21 USC 355 Note: Any information or documentary material that may have been filed pursuant to the pharmaceutical agreement notification
About This Project
This project uses data compiled by the Sunshine in Government initiative, a coalition of journalism and transparency groups. SGI compiled data from federal agency annual FOIA reports to track how often b(3) exemptions were used. SGI also standardized the exemptions since some agencies used slightly different citations of the same laws. In some cases, agencies listed general laws without specifying a section under which information was withheld. This project does not include information from agencies that use no b(3) exemptions in 2008 or 2009. ProPublica compiled information about FOIA denials.
| Department | Claims |
|---|---|
| Federal Trade Commission | 3.0 |
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V--DRUGS AND DEVICES
Part A--Drugs and Devices
Sec. 355. New drugs
(a) Necessity of effective approval of application
No person shall introduce or deliver for introduction into
interstate commerce any new drug, unless an approval of an application
filed pursuant to subsection (b) or (j) of this section is effective
with respect to such drug.
(b) Filing application; contents
(1) Any person may file with the Secretary an application with
respect to any drug subject to the provisions of subsection (a) of this
section. Such person shall submit to the Secretary as a part of the
application (A) full reports of investigations which have been made to
show whether or not such drug is safe for use and whether such drug is
effective in use; (B) a full list of the articles used as components of
such drug; (C) a full statement of the composition of such drug; (D) a
full description of the methods used in, and the facilities and controls
used for, the manufacture, processing, and packing of such drug; (E)
such samples of such drug and of the articles used as components thereof
as the Secretary may require; (F) specimens of the labeling proposed to
be used for such drug, and (G) any assessments required under section
355c of this title. The applicant shall file with the application the
patent number and the expiration date of any patent which claims the
drug for which the applicant submitted the application or which claims a
method of using such drug and with respect to which a claim of patent
infringement could reasonably be asserted if a person not licensed by
the owner engaged in the manufacture, use, or sale of the drug. If an
application is filed under this subsection for a drug and a patent which
claims such drug or a method of using such drug is issued after the
filing date but before approval of the application, the applicant shall
amend the application to include the information required by the
preceding sentence. Upon approval of the application, the Secretary
shall publish information submitted under the two preceding sentences.
The Secretary shall, in consultation with the Director of the National
Institutes of Health and with representatives of the drug manufacturing
industry, review and develop guidance, as appropriate, on the inclusion
of women and minorities in clinical trials required by clause (A).
(2) An application submitted under paragraph (1) for a drug for
which the investigations described in clause (A) of such paragraph and
relied upon by the applicant for approval of the application were not
conducted by or for the applicant and for which the applicant has not
obtained a right of reference or use from the person by or for whom the
investigations were conducted shall also include--
(A) a certification, in the opinion of the applicant and to the
best of his knowledge, with respect to each patent which claims the
drug for which such investigations were conducted or which claims a
use for such drug for which the applicant is seeking approval under
this subsection and for which information is required to be filed
under paragraph (1) or subsection (c) of this section--
(i) that such patent information has not been filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will expire, or
(iv) that such patent is invalid or will not be infringed by
the manufacture, use, or sale of the new drug for which the
application is submitted; and
(B) if with respect to the drug for which investigations
described in paragraph (1)(A) were conducted information was filed
under paragraph (1) or subsection (c) of this section for a method
of use patent which does not claim a use for which the applicant is
seeking approval under this subsection, a statement that the method
of use patent does not claim such a use.
(3) Notice of opinion that patent is invalid or will not be
infringed.--
(A) Agreement to give notice.--An applicant that makes a
certification described in paragraph (2)(A)(iv) shall include in the
application a statement that the applicant will give notice as
required by this paragraph.
(B) Timing of notice.--An applicant that makes a certification
described in paragraph (2)(A)(iv) shall give notice as required
under this paragraph--
(i) if the certification is in the application, not later
than 20 days after the date of the postmark on the notice with
which the Secretary informs the applicant that the application
has been filed; or
(ii) if the certification is in an amendment or supplement
to the application, at the time at which the applicant submits
the amendment or supplement, regardless of whether the applicant
has already given notice with respect to another such
certification contained in the application or in an amendment or
supplement to the application.
(C) Recipients of notice.--An applicant required under this
paragraph to give notice shall give notice to--
(i) each owner of the patent that is the subject of the
certification (or a representative of the owner designated to
receive such a notice); and
(ii) the holder of the approved application under this
subsection for the drug that is claimed by the patent or a use
of which is claimed by the patent (or a representative of the
holder designated to receive such a notice).
(D) Contents of notice.--A notice required under this paragraph
shall--
(i) state that an application that contains data from
bioavailability or bioequivalence studies has been submitted
under this subsection for the drug with respect to which the
certification is made to obtain approval to engage in the
commercial manufacture, use, or sale of the drug before the
expiration of the patent referred to in the certification; and
(ii) include a detailed statement of the factual and legal
basis of the opinion of the applicant that the patent is invalid
or will not be infringed.
(4)(A) An applicant may not amend or supplement an application
referred to in paragraph (2) to seek approval of a drug that is a
different drug than the drug identified in the application as submitted
to the Secretary.
(B) With respect to the drug for which such an application is
submitted, nothing in this subsection or subsection (c)(3) of this
section prohibits an applicant from amending or supplementing the
application to seek approval of a different strength.
(5)(A) The Secretary shall issue guidance for the individuals who
review applications submitted under paragraph (1) or under section 262
of title 42, which shall relate to promptness in conducting the review,
technical excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which shall apply
equally to all individuals who review such applications.
(B) The Secretary shall meet with a sponsor of an investigation or
an applicant for approval for a drug under this subsection or section
262 of title 42 if the sponsor or applicant makes a reasonable written
request for a meeting for the purpose of reaching agreement on the
design and size of clinical trials intended to form the primary basis of
an effectiveness claim. The sponsor or applicant shall provide
information necessary for discussion and agreement on the design and
size of the clinical trials. Minutes of any such meeting shall be
prepared by the Secretary and made available to the sponsor or applicant
upon request.
(C) Any agreement regarding the parameters of the design and size of
clinical trials of a new drug under this paragraph that is reached
between the Secretary and a sponsor or applicant shall be reduced to
writing and made part of the administrative record by the Secretary.
Such agreement shall not be changed after the testing begins, except--
(i) with the written agreement of the sponsor or applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing division, that a
substantial scientific issue essential to determining the safety or
effectiveness of the drug has been identified after the testing has
begun.
(D) A decision under subparagraph (C)(ii) by the director shall be
in writing and the Secretary shall provide to the sponsor or applicant
an opportunity for a meeting at which the director and the sponsor or
applicant will be present and at which the director will document the
scientific issue involved.
(E) The written decisions of the reviewing division shall be binding
upon, and may not di
rectly or indirectly be changed by, the field or compliance division
personnel unless such field or compliance division personnel demonstrate
to the reviewing division why such decision should be modified.
(F) No action by the reviewing division may be delayed because of
the unavailability of information from or action by field personnel
unless the reviewing division determines that a delay is necessary to
assure the marketing of a safe and effective drug.
(G) For purposes of this paragraph, the reviewing division is the
division responsible for the review of an application for approval of a
drug under this subsection or section 262 of title 42 (including all
scientific and medical matters, chemistry, manufacturing, and controls).
(c) Period for approval of application; period for, notice, and
expedition of hearing; period for issuance of order
(1) Within one hundred and eighty days after the filing of an
application under subsection (b) of this section, or such additional
period as may be agreed upon by the Secretary and the applicant, the
Secretary shall either--
(A) approve the application if he then finds that none of the
grounds for denying approval specified in subsection (d) of this
section applies, or
(B) give the applicant notice of an opportunity for a hearing
before the Secretary under subsection (d) of this section on the
question whether such application is approvable. If the applicant
elects to accept the opportunity for hearing by written request
within thirty days after such notice, such hearing shall commence
not more than ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree. Any such
hearing shall thereafter be conducted on an expedited basis and the
Secretary's order thereon shall be issued within ninety days after
the date fixed by the Secretary for filing final briefs.
(2) If the patent information described in subsection (b) of this
section could not be filed with the submission of an application under
subsection (b) of this section because the application was filed before
the patent information was required under subsection (b) of this section
or a patent was issued after the application was approved under such
subsection, the holder of an approved application shall file with the
Secretary the patent number and the expiration date of any patent which
claims the drug for which the application was submitted or which claims
a method of using such drug and with respect to which a claim of patent
infringement could reasonably be asserted if a person not licensed by
the owner engaged in the manufacture, use, or sale of the drug. If the
holder of an approved application could not file patent information
under subsection (b) of this section because it was not required at the
time the application was approved, the holder shall file such
information under this subsection not later than thirty days after
September 24, 1984, and if the holder of an approved application could
not file patent information under subsection (b) of this section because
no patent had been issued when an application was filed or approved, the
holder shall file such information under this subsection not later than
thirty days after the date the patent involved is issued. Upon the
submission of patent information under this subsection, the Secretary
shall publish it.
(3) The approval of an application filed under subsection (b) of
this section which contains a certification required by paragraph (2) of
such subsection shall be made effective on the last applicable date
determined by applying the following to each certification made under
subsection (b)(2)(A) of this section:
(A) If the applicant only made a certification described in
clause (i) or (ii) of subsection (b)(2)(A) of this section or in
both such clauses, the approval may be made effective immediately.
(B) If the applicant made a certification described in clause
(iii) of subsection (b)(2)(A) of this section, the approval may be
made effective on the date certified under clause (iii).
(C) If the applicant made a certification described in clause
(iv) of subsection (b)(2)(A) of this section, the approval shall be
made effective immediately unless, before the expiration of 45 days
after the date on which the notice described in subsection (b)(3) of
this section is received, an action is brought for infringement of
the patent that is the subject of the certification and for which
information was submitted to the Secretary under paragraph (2) or
subsection (b)(1) of this section before the date on which the
application (excluding an amendment or supplement to the
application) was submitted. If such an action is brought before the
expiration of such days, the approval may be made effective upon the
expiration of the thirty-month period beginning on the date of the
receipt of the notice provided under subsection (b)(3) of this
section or such shorter or longer period as the court may order
because either party to the action failed to reasonably cooperate in
expediting the action, except that--
(i) if before the expiration of such period the district
court decides that the patent is invalid or not infringed
(including any substantive determination that there is no cause
of action for patent infringement or invalidity), the approval
shall be made effective on--
(I) the date on which the court enters judgment
reflecting the decision; or
(II) the date of a settlement order or consent decree
signed and entered by the court stating that the patent that
is the subject of the certification is invalid or not
infringed;
(ii) if before the expiration of such period the district
court decides that the patent has been infringed--
(I) if the judgment of the district court is appealed,
the approval shall be made effective on--
(aa) the date on which the court of appeals decides
that the patent is invalid or not infringed (including
any substantive determination that there is no cause of
action for patent infringement or invalidity); or
(bb) the date of a settlement order or consent
decree signed and entered by the court of appeals
stating that the patent that is the subject of the
certification is invalid or not infringed; or
(II) if the judgment of the district court is not
appealed or is affirmed, the approval shall be made
effective on the date specified by the district court in a
court order under section 271(e)(4)(A) of title 35;
(iii) if before the expiration of such period the court
grants a preliminary injunction prohibiting the applicant from
engaging in the commercial manufacture or sale of the drug until
the court decides the issues of patent validity and infringement
and if the court decides that such patent is invalid or not
infringed, the approval shall be made effective as provided in
clause (i); or
(iv) if before the expiration of such period the court
grants a preliminary injunction prohibiting the applicant from
engaging in the commercial manufacture or sale of the drug until
the court decides the issues of patent validity and infringement
and if the court decides that such patent has been infringed,
the approval shall be made effective as provided in clause (ii).
In such an action, each of the parties shall reasonably cooperate in
expediting the action.
(D) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement action.--
(I) In general.--No action may be brought under section
2201 of title 28 by an applicant referred to in subsection
(b)(2) of this section for a declaratory judgment with
respect to a patent which is the subject of the
certification referred to in subparagraph (C) unless--
(aa) the 45-day period referred to in such
subparagraph has expired;
(bb) neither the owner of such patent nor the holder
of the approved application under subsection (b) of this
section for the drug that is claimed by the patent or a
use of which is claimed by the patent brought a civil
action against the applicant for infringement of the
patent before the expiration of such period; and
(cc) in any case in which the notice provided under
paragraph (2)(B) relates to noninfringement, the notice
was accompanied by a document described in subclause
(III).
(II) Filing of civil action.--If the conditions
described in items (aa), (bb), and as applicable, (cc) of
subclause (I) have been met, the applicant referred to in
such subclause may, in accordance with section 2201 of title
28, bring a civil action under such section against the
owner or holder referred to in such subclause (but not
against any owner or holder that has brought such a civil
action against the applicant, unless that civil action was
dismissed without prejudice) for a declaratory judgment that
the patent is invalid or will not be infringed by the drug
for which the applicant seeks approval, except that such
civil action may be brought for a declaratory judgment that
the patent will not be infringed only in a case in which the
condition described in subclause (I)(cc) is applicable. A
civil action referred to in this subclause shall be brought
in the judicial district where the defendant has its
principal place of business or a regular and established
place of business.
(III) Offer of confidential access to application.--For
purposes of subclause (I)(cc), the document described in
this subclause is a document providing an offer of
confidential access to the application that is in the
custody of the applicant referred to in subsection (b)(2) of
this section for the purpose of determining whether an
action referred to in subparagraph (C) should be brought.
The document providing the offer of confidential access
shall contain such restrictions as to persons entitled to
access, and on the use and disposition of any information
accessed, as would apply had a protective order been entered
for the purpose of protecting trade secrets and other
confidential business information. A request for access to
an application under an offer of confidential access shall
be considered acceptance of the offer of confidential access
with the restrictions as to persons entitled to access, and
on the use and disposition of any information accessed,
contained in the offer of confidential access, and those
restrictions and other terms of the offer of confidential
access shall be considered terms of an enforceable contract.
Any person provided an offer of confidential access shall
review the application for the sole and limited purpose of
evaluating possible infringement of the patent that is the
subject of the certification under subsection (b)(2)(A)(iv)
of this section and for no other purpose, and may not
disclose information of no relevance to any issue of patent
infringement to any person other than a person provided an
offer of confidential access. Further, the application may
be redacted by the applicant to remove any information of no
relevance to any issue of patent infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the patent or the holder
of the approved application under subsection (b) of this
section for the drug that is claimed by the patent or a use
of which is claimed by the patent brings a patent
infringement action against the applicant, the applicant may
assert a counterclaim seeking an order requiring the holder
to correct or delete the patent information submitted by the
holder under subsection (b) of this section or this
subsection on the ground that the patent does not claim
either--
(aa) the drug for which the application was
approved; or
(bb) an approved method of using the drug.
(II) No independent cause of action.--Subclause (I) does
not authorize the assertion of a claim described in
subclause (I) in any civil action or proceeding other than a
counterclaim described in subclause (I).
(iii) No damages.--An applicant shall not be entitled to
damages in a civil action under clause (i) or a counterclaim
under clause (ii).
(E)(i) If an application (other than an abbreviated new drug
application) submitted under subsection (b) of this section for a
drug, no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under subsection (b) of this section, was approved
during the period beginning January 1, 1982, and ending on September
24, 1984, the Secretary may not make the approval of another
application for a drug for which the investigations described in
clause (A) of subsection (b)(1) of this section and relied upon by
the applicant for approval of the application were not conducted by
or for the applicant and for which the applicant has not obtained a
right of reference or use from the person by or for whom the
investigations were conducted effective before the expiration of ten
years from the date of the approval of the application previously
approved under subsection (b) of this section.
(ii) If an application submitted under subsection (b) of this
section for a drug, no active ingredient (including any ester or
salt of the active ingredient) of which has been approved in any
other application under subsection (b) of this section, is approved
after September 24, 1984, no application which refers to the drug
for which the subsection (b) application was submitted and for which
the investigations described in clause (A) of subsection (b)(1) of
this section and relied upon by the applicant for approval of the
application were not conducted by or for the applicant and for which
the applicant has not obtained a right of reference or use from the
person by or for whom the investigations were conducted may be
submitted under subsection (b) of this section before the expiration
of five years from the date of the approval of the application under
subsection (b) of this section, except that such an application may
be submitted under subsection (b) of this section after the
expiration of four years from the date of the approval of the
subsection (b) application if it contains a certification of patent
invalidity or noninfringement described in clause (iv) of subsection
(b)(2)(A) of this section. The approval of such an application shall
be made effective in accordance with this paragraph except that, if
an action for patent infringement is commenced during the one-year
period beginning forty-eight months after the date of the approval
of the subsection (b) application, the thirty-month period referred
to in subparagraph (C) shall be extended by such amount of time (if
any) which is required for seven and one-half years to have elapsed
from the date of approval of the subsection (b) application.
(iii) If an application submitted under subsection (b) of this
section for a drug, which includes an active ingredient (including
any ester or salt of the active ingredient) that has been approved
in another application approved under subsection (b) of this
section, is approved after September 24, 1984, and if such
application contains reports of new clinical investigations (other
than bioavailability studies) essential to the approval of the
application and conducted or sponsored by the applicant, the
Secretary may not make the approval of an application submitted
under subsection (b) of this section for the conditions of approval
of such drug in the approved subsection (b) application effective
before the expiration of three years from the date of the approval
of the application under subsection (b) of this section if the
investigations described in clause (A) of subsection (b)(1) of this
section and relied upon by the applicant for approval of the
application were not conducted by or for the applicant and if the
applicant has not obtained a right of reference or use from the
person by or for whom the investigations were conducted.
(iv) If a supplement to an application approved under subsection
(b) of this section is approved after September 24, 1984, and the
supplement contains reports of new clinical investigations (other
than bioavailabilty \1\ studies) essential to the approval of the
supplement and conducted or sponsored by the person submitting the
supplement, the Secretary may not make the approval of an
application submitted under subsection (b) of this section for a
change approved in the supplement effective before the expiration of
three years from the date of the approval of the supplement under
subsection (b) of this section if the investigations described in
clause (A) of subsection (b)(1) of this section and relied upon by
the applicant for approval of the application were not conducted by
or for the applicant and if the applicant has not obtained a right
of reference or use from the person by or for whom the
investigations were conducted.
---------------------------------------------------------------------------
\1\ So in original. Probably should be ``bioavailability''.
---------------------------------------------------------------------------
(v) If an application (or supplement to an application)
submitted under subsection (b) of this section for a drug, which
includes an active ingredient (including any ester or salt of the
active ingredient) that has been approved in another application
under subsection (b) of this section, was approved during the period
beginning January 1, 1982, and ending on September 24, 1984, the
Secretary may not make the approval of an application submitted
under this subsection and for which the investigations described in
clause (A) of subsection (b)(1) of this section and relied upon by
the applicant for approval of the application were not conducted by
or for the applicant and for which the applicant has not obtained a
right of reference or use from the person by or for whom the
investigations were conducted and which refers to the drug for which
the subsection (b) application was submitted effective before the
expiration of two years from September 24, 1984.
(4) A drug manufactured in a pilot or other small facility may be
used to demonstrate the
safety and effectiveness of the drug and to obtain approval for the drug
prior to manufacture of the drug in a larger facility, unless the
Secretary makes a determination that a full scale production facility is
necessary to ensure the safety or effectiveness of the drug.
(d) Grounds for refusing application; approval of application;
``substantial evidence'' defined
If the Secretary finds, after due notice to the applicant in
accordance with subsection (c) of this section and giving him an
opportunity for a hearing, in accordance with said subsection, that (1)
the investigations, reports of which are required to be submitted to the
Secretary pursuant to subsection (b) of this section, do not include
adequate tests by all methods reasonably applicable to show whether or
not such drug is safe for use under the conditions prescribed,
recommended, or suggested in the proposed labeling thereof; (2) the
results of such tests show that such drug is unsafe for use under such
conditions or do not show that such drug is safe for use under such
conditions; (3) the methods used in, and the facilities and controls
used for, the manufacture, processing, and packing of such drug are
inadequate to preserve its identity, strength, quality, and purity; (4)
upon the basis of the information submitted to him as part of the
application, or upon the basis of any other information before him with
respect to such drug, he has insufficient information to determine
whether such drug is safe for use under such conditions; or (5)
evaluated on the basis of the information submitted to him as part of
the application and any other information before him with respect to
such drug, there is a lack of substantial evidence that the drug will
have the effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the proposed
labeling thereof; or (6) the application failed to contain the patent
information prescribed by subsection (b) of this section; or (7) based
on a fair evaluation of all material facts, such labeling is false or
misleading in any particular; he shall issue an order refusing to
approve the application. If, after such notice and opportunity for
hearing, the Secretary finds that clauses (1) through (6) do not apply,
he shall issue an order approving the application. As used in this
subsection and subsection (e) of this section, the term ``substantial
evidence'' means evidence consisting of adequate and well-controlled
investigations, including clinical investigations, by experts qualified
by scientific training and experience to evaluate the effectiveness of
the drug involved, on the basis of which it could fairly and responsibly
be concluded by such experts that the drug will have the effect it
purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling or proposed
labeling thereof. If the Secretary determines, based on relevant
science, that data from one adequate and well-controlled clinical
investigation and confirmatory evidence (obtained prior to or after such
investigation) are sufficient to establish effectiveness, the Secretary
may consider such data and evidence to constitute substantial evidence
for purposes of the preceding sentence.
(e) Withdrawal of approval; grounds; immediate suspension upon finding
imminent hazard to public health
The Secretary shall, after due notice and opportunity for hearing to
the applicant, withdraw approval of an application with respect to any
drug under this section if the Secretary finds (1) that clinical or
other experience, tests, or other scientific data show that such drug is
unsafe for use under the conditions of use upon the basis of which the
application was approved; (2) that new evidence of clinical experience,
not contained in such application or not available to the Secretary
until after such application was approved, or tests by new methods, or
tests by methods not deemed reasonably applicable when such application
was approved, evaluated together with the evidence available to the
Secretary when the application was approved, shows that such drug is not
shown to be safe for use under the conditions of use upon the basis of
which the application was approved; or (3) on the basis of new
information before him with respect to such drug, evaluated together
with the evidence available to him when the application was approved,
that there is a lack of substantial evidence that the drug will have the
effect it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling thereof; or (4)
the patent information prescribed by subsection (c) of this section was
not filed within thirty days after the receipt of written notice from
the Secretary specifying the failure to file such information; or (5)
that the application contains any untrue statement of a material fact:
Provided, That if the Secretary (or in his absence the officer acting as
Secretary) finds that there is an imminent hazard to the public health,
he may suspend the approval of such application immediately, and give
the applicant prompt notice of his action and afford the applicant the
opportunity for an expedited hearing under this subsection; but the
authority conferred by this proviso to suspend the approval of an
application shall not be delegated. The Secretary may also, after due
notice and opportunity for hearing to the applicant, withdraw the
approval of an application submitted under subsection (b) or (j) of this
section with respect to any drug under this section if the Secretary
finds (1) that the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately failed
to maintain such records or to make required reports, in accordance with
a regulation or order under subsection (k) of this section or to comply
with the notice requirements of section 360(k)(2) of this title, or the
applicant has refused to permit access to, or copying or verification
of, such records as required by paragraph (2) of such subsection; or (2)
that on the basis of new information before him, evaluated together with
the evidence before him when the application was approved, the methods
used in, or the facilities and controls used for, the manufacture,
processing, and packing of such drug are inadequate to assure and
preserve its identity, strength, quality, and purity and were not made
adequate within a reasonable time after receipt of written notice from
the Secretary specifying the matter complained of;
or (3) that on the basis of new information before him, evaluated
together with the evidence before him when the application was approved,
the labeling of such drug, based on a fair evaluation of all material
facts, is false or misleading in any particular and was not corrected
within a reasonable time after receipt of written notice from the
Secretary specifying the matter complained of. Any order under this
subsection shall state the findings upon which it is based.
(f) Revocation of order refusing, withdrawing or suspending approval of
application
Whenever the Secretary finds that the facts so require, he shall
revoke any previous order under subsection (d) or (e) of this section
refusing, withdrawing, or suspending approval of an application and
shall approve such application or reinstate such approval, as may be
appropriate.
(g) Service of orders
Orders of the Secretary issued under this section shall be served
(1) in person by any officer or employee of the department designated by
the Secretary or (2) by mailing the order by registered mail or by
certified mail addressed to the applicant or respondent at his last-
known address in the records of the Secretary.
(h) Appeal from order
An appeal may be taken by the applicant from an order of the
Secretary refusing or withdrawing approval of an application under this
section. Such appeal shall be taken by filing in the United States court
of appeals for the circuit wherein such applicant resides or has his
principal place of business, or in the United States Court of Appeals
for the District of Columbia Circuit, within sixty days after the entry
of such order, a written petition praying that the order of the
Secretary be set aside. A copy of such petition shall be forthwith
transmitted by the clerk of the court to the Secretary, or any officer
designated by him for that purpose, and thereupon the Secretary shall
certify and file in the court the record upon which the order complained
of was entered, as provided in section 2112 of title 28. Upon the filing
of such petition such court shall have exclusive jurisdiction to affirm
or set aside such order, except that until the filing of the record the
Secretary may modify or set aside his order. No objection to the order
of the Secretary shall be considered by the court unless such objection
shall have been urged before the Secretary or unless there were
reasonable grounds for failure so to do. The finding of the Secretary as
to the facts, if supported by substantial evidence, shall be conclusive.
If any person shall apply to the court for leave to adduce additional
evidence, and shall show to the satisfaction of the court that such
additional evidence is material and that there were reasonable grounds
for failure to adduce such evidence in the proceeding before the
Secretary, the court may order such additional evidence to be taken
before the Secretary and to be adduced upon the hearing in such manner
and upon such terms and conditions as to the court may seem proper. The
Secretary may modify his findings as to the facts by reason of the
additional evidence so taken, and he shall file with the court such
modified findings which, if supported by substantial evidence, shall be
conclusive, and his recommendation, if any, for the setting aside of the
original order. The judgment of the court affirming or setting aside any
such order of the Secretary shall be final, subject to review by the
Supreme Court of the United States upon certiorari or certification as
provided in section 1254 of title 28. The commencement of proceedings
under this subsection shall not, unless specifically ordered by the
court to the contrary, operate as a stay of the Secretary's order.
(i) Exemptions of drugs for research; discretionary and mandatory
conditions; direct reports to Secretary
(1) The Secretary shall promulgate regulations for exempting from
the operation of the foregoing subsections of this section drugs
intended solely for investigational use by experts qualified by
scientific training and experience to investigate the safety and
effectiveness of drugs. Such regulations may, within the discretion of
the Secretary, among other conditions relating to the protection of the
public health, provide for conditioning such exemption upon--
(A) the submission to the Secretary, before any clinical testing
of a new drug is undertaken, of reports, by the manufacturer or the
sponsor of the investigation of such drug, of preclinical tests
(including tests on animals) of such drug adequate to justify the
proposed clinical testing;
(B) the manufacturer or the sponsor of the investigation of a
new drug proposed to be distributed to investigators for clinical
testing obtaining a signed agreement from each of such investigators
that patients to whom the drug is administered will be under his
personal supervision, or under the supervision of investigators
responsible to him, and that he will not supply such drug to any
other investigator, or to clinics, for administration to human
beings;
(C) the establishment and maintenance of such records, and the
making of such reports to the Secretary, by the manufacturer or the
sponsor of the investigation of such drug, of data (including but
not limited to analytical reports by investigators) obtained as the
result of such investigational use of such drug, as the Secretary
finds will enable him to evaluate the safety and effectiveness of
such drug in the event of the filing of an application pursuant to
subsection (b) of this section; and
(D) the submission to the Secretary by the manufacturer or the
sponsor of the investigation of a new drug of a statement of intent
regarding whether the manufacturer or sponsor has plans for
assessing pediatric safety and efficacy.
(2) Subject to paragraph (3), a clinical investigation of a new drug
may begin 30 days after the Secretary has received from the manufacturer
or sponsor of the investigation a submission containing such information
about the drug and the clinical investigation, including--
(A) information on design of the investigation and adequate
reports of basic information, certified by the applicant to be
accurate
reports, necessary to assess the safety of the drug for use in
clinical investigation; and
(B) adequate information on the chemistry and manufacturing of
the drug, controls available for the drug, and primary data
tabulations from animal or human studies.
(3)(A) At any time, the Secretary may prohibit the sponsor of an
investigation from conducting the investigation (referred to in this
paragraph as a ``clinical hold'') if the Secretary makes a determination
described in subparagraph (B). The Secretary shall specify the basis for
the clinical hold, including the specific information available to the
Secretary which served as the basis for such clinical hold, and confirm
such determination in writing.
(B) For purposes of subparagraph (A), a determination described in
this subparagraph with respect to a clinical hold is that--
(i) the drug involved represents an unreasonable risk to the
safety of the persons who are the subjects of the clinical
investigation, taking into account the qualifications of the
clinical investigators, information about the drug, the design of
the clinical investigation, the condition for which the drug is to
be investigated, and the health status of the subjects involved; or
(ii) the clinical hold should be issued for such other reasons
as the Secretary may by regulation establish (including reasons
established by regulation before November 21, 1997).
(C) Any written request to the Secretary from the sponsor of an
investigation that a clinical hold be removed shall receive a decision,
in writing and specifying the reasons therefor, within 30 days after
receipt of such request. Any such request shall include sufficient
information to support the removal of such clinical hold.
(4) Regulations under paragraph (1) shall provide that such
exemption shall be conditioned upon the manufacturer, or the sponsor of
the investigation, requiring that experts using such drugs for
investigational purposes certify to such manufacturer or sponsor that
they will inform any human beings to whom such drugs, or any controls
used in connection therewith, are being administered, or their
representatives, that such drugs are being used for investigational
purposes and will obtain the consent of such human beings or their
representatives, except where it is not feasible or it is contrary to
the best interests of such human beings. Nothing in this subsection
shall be construed to require any clinical investigator to submit
directly to the Secretary reports on the investigational use of drugs.
(j) Abbreviated new drug applications
(1) Any person may file with the Secretary an abbreviated
application for the approval of a new drug.
(2)(A) An abbreviated application for a new drug shall contain--
(i) information to show that the conditions of use prescribed,
recommended, or suggested in the labeling proposed for the new drug
have been previously approved for a drug listed under paragraph (7)
(hereinafter in this subsection referred to as a ``listed drug'');
(ii)(I) if the listed drug referred to in clause (i) has only
one active ingredient, information to show that the active
ingredient of the new drug is the same as that of the listed drug;
(II) if the listed drug referred to in clause (i) has more than
one active ingredient, information to show that the active
ingredients of the new drug are the same as those of the listed
drug, or
(III) if the listed drug referred to in clause (i) has more than
one active ingredient and if one of the active ingredients of the
new drug is different and the application is filed pursuant to the
approval of a petition filed under subparagraph (C), information to
show that the other active ingredients of the new drug are the same
as the active ingredients of the listed drug, information to show
that the different active ingredient is an active ingredient of a
listed drug or of a drug which does not meet the requirements of
section 321(p) of this title, and such other information respecting
the different active ingredient with respect to which the petition
was filed as the Secretary may require;
(iii) information to show that the route of administration, the
dosage form, and the strength of the new drug are the same as those
of the listed drug referred to in clause (i) or, if the route of
administration, the dosage form, or the strength of the new drug is
different and the application is filed pursuant to the approval of a
petition filed under subparagraph (C), such information respecting
the route of administration, dosage form, or strength with respect
to which the petition was filed as the Secretary may require;
(iv) information to show that the new drug is bioequivalent to
the listed drug referred to in clause (i), except that if the
application is filed pursuant to the approval of a petition filed
under subparagraph (C), information to show that the active
ingredients of the new drug are of the same pharmacological or
therapeutic class as those of the listed drug referred to in clause
(i) and the new drug can be expected to have the same therapeutic
effect as the listed drug when administered to patients for a
condition of use referred to in clause (i);
(v) information to show that the labeling proposed for the new
drug is the same as the labeling approved for the listed drug
referred to in clause (i) except for changes required because of
differences approved under a petition filed under subparagraph (C)
or because the new drug and the listed drug are produced or
distributed by different manufacturers;
(vi) the items specified in clauses (B) through (F) of
subsection (b)(1) of this section;
(vii) a certification, in the opinion of the applicant and to
the best of his knowledge, with respect to each patent which claims
the listed drug referred to in clause (i) or which claims a use for
such listed drug for which the applicant is seeking approval under
this subsection and for which information is required to be filed
under subsection (b) or (c) of this section--
(I) that such patent information has not been filed,
(II) that such patent has expired,
(III) of the date on which such patent will expire, or
(IV) that such patent is invalid or will not be infringed by
the manufacture, use, or sale of the new drug for which the
application is submitted; and
(viii) if with respect to the listed drug referred to in clause
(i) information was filed under subsection (b) or (c) of this
section for a method of use patent which does not claim a use for
which the applicant is seeking approval under this subsection, a
statement that the method of use patent does not claim such a use.
The Secretary may not require that an abbreviated application contain
information in addition to that required by clauses (i) through (viii).
(B) Notice of opinion that patent is invalid or will not be
infringed.--
(i) Agreement to give notice.--An applicant that makes a
certification described in subparagraph (A)(vii)(IV) shall include
in the application a statement that the applicant will give notice
as required by this subparagraph.
(ii) Timing of notice.--An applicant that makes a certification
described in subparagraph (A)(vii)(IV) shall give notice as required
under this subparagraph--
(I) if the certification is in the application, not later
than 20 days after the date of the postmark on the notice with
which the Secretary informs the applicant that the application
has been filed; or
(II) if the certification is in an amendment or supplement
to the application, at the time at which the applicant submits
the amendment or supplement, regardless of whether the applicant
has already given notice with respect to another such
certification contained in the application or in an amendment or
supplement to the application.
(iii) Recipients of notice.--An applicant required under this
subparagraph to give notice shall give notice to--
(I) each owner of the patent that is the subject of the
certification (or a representative of the owner designated to
receive such a notice); and
(II) the holder of the approved application under subsection
(b) of this section for the drug that is claimed by the patent
or a use of which is claimed by the patent (or a representative
of the holder designated to receive such a notice).
(iv) Contents of notice.--A notice required under this
subparagraph shall--
(I) state that an application that contains data from
bioavailability or bioequivalence studies has been submitted
under this subsection for the drug with respect to which the
certification is made to obtain approval to engage in the
commercial manufacture, use, or sale of the drug before the
expiration of the patent referred to in the certification; and
(II) include a detailed statement of the factual and legal
basis of the opinion of the applicant that the patent is invalid
or will not be infringed.
(C) If a person wants to submit an abbreviated application for a new
drug which has a different active ingredient or whose route of
administration, dosage form, or strength differ from that of a listed
drug, such person shall submit a petition to the Secretary seeking
permission to file such an application. The Secretary shall approve or
disapprove a petition submitted under this subparagraph within ninety
days of the date the petition is submitted. The Secretary shall approve
such a petition unless the Secretary finds--
(i) that investigations must be conducted to show the safety and
effectiveness of the drug or of any of its active ingredients, the
route of administration, the dosage form, or strength which differ
from the listed drug; or
(ii) that any drug with a different active ingredient may not be
adequately evaluated for approval as safe and effective on the basis
of the information required to be submitted in an abbreviated
application.
(D)(i) An applicant may not amend or supplement an application to
seek approval of a drug referring to a different listed drug from the
listed drug identified in the application as submitted to the Secretary.
(ii) With respect to the drug for which an application is submitted,
nothing in this subsection prohibits an applicant from amending or
supplementing the application to seek approval of a different strength.
(iii) Within 60 days after December 8, 2003, the Secretary shall
issue guidance defining the term ``listed drug'' for purposes of this
subparagraph.
(3)(A) The Secretary shall issue guidance for the individuals who
review applications submitted under paragraph (1), which shall relate to
promptness in conducting the review, technical excellence, lack of bias
and conflict of interest, and knowledge of regulatory and scientific
standards, and which shall apply equally to all individuals who review
such applications.
(B) The Secretary shall meet with a sponsor of an investigation or
an applicant for approval for a drug under this subsection if the
sponsor or applicant makes a reasonable written request for a meeting
for the purpose of reaching agreement on the design and size of
bioavailability and bioequivalence studies needed for approval of such
application. The sponsor or applicant shall provide information
necessary for discussion and agreement on the design and size of such
studies. Minutes of any such meeting shall be prepared by the Secretary
and made available to the sponsor or applicant.
(C) Any agreement regarding the parameters of design and size of
bioavailability and bioequivalence studies of a drug under this
paragraph that is reached between the Secretary and a sponsor or
applicant shall be reduced to writing and made part of the
administrative record by the Secretary. Such agreement shall not be
changed after the testing begins, except--
(i) with the written agreement of the sponsor or applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of
the reviewing division, that a substantial scientific issue
essential to determining the safety or effectiveness of the drug has
been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director shall be
in writing and the Secretary shall provide to the sponsor or applicant
an opportunity for a meeting at which the director and the sponsor or
applicant will be present and at which the director will document the
scientific issue involved.
(E) The written decisions of the reviewing division shall be binding
upon, and may not directly or indirectly be changed by, the field or
compliance office personnel unless such field or compliance office
personnel demonstrate to the reviewing division why such decision should
be modified.
(F) No action by the reviewing division may be delayed because of
the unavailability of information from or action by field personnel
unless the reviewing division determines that a delay is necessary to
assure the marketing of a safe and effective drug.
(G) For purposes of this paragraph, the reviewing division is the
division responsible for the review of an application for approval of a
drug under this subsection (including scientific matters, chemistry,
manufacturing, and controls).
(4) Subject to paragraph (5), the Secretary shall approve an
application for a drug unless the Secretary finds--
(A) the methods used in, or the facilities and controls used
for, the manufacture, processing, and packing of the drug are
inadequate to assure and preserve its identity, strength, quality,
and purity;
(B) information submitted with the application is insufficient
to show that each of the proposed conditions of use have been
previously approved for the listed drug referred to in the
application;
(C)(i) if the listed drug has only one active ingredient,
information submitted with the application is insufficient to show
that the active ingredient is the same as that of the listed drug;
(ii) if the listed drug has more than one active ingredient,
information submitted with the application is insufficient to show
that the active ingredients are the same as the active ingredients
of the listed drug, or
(iii) if the listed drug has more than one active ingredient and
if the application is for a drug which has an active ingredient
different from the listed drug, information submitted with the
application is insufficient to show--
(I) that the other active ingredients are the same as the
active ingredients of the listed drug, or
(II) that the different active ingredient is an active
ingredient of a listed drug or a drug which does not meet the
requirements of section 321(p) of this title,
or no petition to file an application for the drug with the
different ingredient was approved under paragraph (2)(C);
(D)(i) if the application is for a drug whose route of
administration, dosage form, or strength of the drug is the same as
the route of administration, dosage form, or strength of the listed
drug referred to in the application, information submitted in the
application is insufficient to show that the route of
administration, dosage form, or strength is the same as that of the
listed drug, or
(ii) if the application is for a drug whose route of
administration, dosage form, or strength of the drug is different
from that of the listed drug referred to in the application, no
petition to file an application for the drug with the different
route of administration, dosage form, or strength was approved under
paragraph (2)(C);
(E) if the application was filed pursuant to the approval of a
petition under paragraph (2)(C), the application did not contain the
information required by the Secretary respecting the active
ingredient, route of administration, dosage form, or strength which
is not the same;
(F) information submitted in the application is insufficient to
show that the drug is bioequivalent to the listed drug referred to
in the application or, if the application was filed pursuant to a
petition approved under paragraph (2)(C), information submitted in
the application is insufficient to show that the active ingredients
of the new drug are of the same pharmacological or therapeutic class
as those of the listed drug referred to in paragraph (2)(A)(i) and
that the new drug can be expected to have the same therapeutic
effect as the listed drug when administered to patients for a
condition of use referred to in such paragraph;
(G) information submitted in the application is insufficient to
show that the labeling proposed for the drug is the same as the
labeling approved for the listed drug referred to in the application
except for changes required because of differences approved under a
petition filed under paragraph (2)(C) or because the drug and the
listed drug are produced or distributed by different manufacturers;
(H) information submitted in the application or any other
information available to the Secretary shows that (i) the inactive
ingredients of the drug are unsafe for use under the conditions
prescribed, recommended, or suggested in the labeling proposed for
the drug, or (ii) the composition of the drug is unsafe under such
conditions because of the type or quantity of inactive ingredients
included or the manner in which the inactive ingredients are
included;
(I) the approval under subsection (c) of this section of the
listed drug referred to in the application under this subsection has
been withdrawn or suspended for grounds described in the first
sentence of subsection (e) of this section, the Secretary has
published a notice of opportunity for hearing to withdraw approval
of the listed drug under subsection (c) of this section for grounds
described in the first sentence of subsection (e) of this section,
the approval under this subsection of the listed drug referred to in
the application under this subsection has been withdrawn or
suspended under paragraph (6), or the Secretary has determined that
the listed drug has been withdrawn from sale for safety or
effectiveness reasons;
(J) the application does not meet any other requirement of
paragraph (2)(A); or
(K) the application contains an untrue statement of material
fact.
(5)(A) Within one hundred and eighty days of the initial receipt of
an application under paragraph (2) or within such additional period as
may be agreed upon by the Secretary and the applicant, the Secretary
shall approve or disapprove the application.
(B) The approval of an application submitted under paragraph (2)
shall be made effective on the last applicable date determined by
applying the following to each certification made under paragraph
(2)(A)(vii):
(i) If the applicant only made a certification described in
subclause (I) or (II) of paragraph (2)(A)(vii) or in both such
subclauses, the approval may be made effective immediately.
(ii) If the applicant made a certification described in
subclause (III) of paragraph (2)(A)(vii), the approval may be made
effective on the date certified under subclause (III).
(iii) If the applicant made a certification described in
subclause (IV) of paragraph (2)(A)(vii), the approval shall be made
effective immediately unless, before the expiration of 45 days after
the date on which the notice described in paragraph (2)(B) is
received, an action is brought for infringement of the patent that
is the subject of the certification and for which information was
submitted to the Secretary under subsection (b)(1) or (c)(2) of this
section before the date on which the application (excluding an
amendment or supplement to the application), which the Secretary
later determines to be substantially complete, was submitted. If
such an action is brought before the expiration of such days, the
approval shall be made effective upon the expiration of the thirty-
month period beginning on the date of the receipt of the notice
provided under paragraph (2)(B)(i) or such shorter or longer period
as the court may order because either party to the action failed to
reasonably cooperate in expediting the action, except that--
(I) if before the expiration of such period the district
court decides that the patent is invalid or not infringed
(including any substantive determination that there is no cause
of action for patent infringement or invalidity), the approval
shall be made effective on--
(aa) the date on which the court enters judgment
reflecting the decision; or
(bb) the date of a settlement order or consent decree
signed and entered by the court stating that the patent that
is the subject of the certification is invalid or not
infringed;
(II) if before the expiration of such period the district
court decides that the patent has been infringed--
(aa) if the judgment of the district court is appealed,
the approval shall be made effective on--
(AA) the date on which the court of appeals decides
that the patent is invalid or not infringed (including
any substantive determination that there is no cause of
action for patent infringement or invalidity); or
(BB) the date of a settlement order or consent
decree signed and entered by the court of appeals
stating that the patent that is the subject of the
certification is invalid or not infringed; or
(bb) if the judgment of the district court is not
appealed or is affirmed, the approval shall be made
effective on the date specified by the district court in a
court order under section 271(e)(4)(A) of title 35;
(III) if before the expiration of such period the court
grants a preliminary injunction prohibiting the applicant from
engaging in the commercial manufacture or sale of the drug until
the court decides the issues of patent validity and infringement
and if the court decides that such patent is invalid or not
infringed, the approval shall be made effective as provided in
subclause (I); or
(IV) if before the expiration of such period the court
grants a preliminary injunction prohibiting the applicant from
engaging in the commercial manufacture or sale of the drug until
the court decides the issues of patent validity and infringement
and if the court decides that such patent has been infringed,
the approval shall be made effective as provided in subclause
(II).
In such an action, each of the parties shall reasonably cooperate in
expediting the action.
(iv) 180-day exclusivity period.--
(I) Effectiveness of application.--Subject to subparagraph
(D), if the application contains a certification described in
paragraph (2)(A)(vii)(IV) and is for a drug for which a first
applicant has submitted an application containing such a
certification, the application shall be made effective on the
date that is 180 days after the date of the first commercial
marketing of the drug (including the commercial marketing of the
listed drug) by any first applicant.
(II) Definitions.--In this paragraph:
(aa) 180-day exclusivity period.--The term ``180-day
exclusivity period'' means the 180-day period ending on the
day before the date on which an application submitted by an
applicant other than a first applicant could become
effective under this clause.
(bb) First applicant.--As used in this subsection, the
term ``first applicant'' means an applicant that, on the
first day on which a substantially complete application
containing a certification described in paragraph
(2)(A)(vii)(IV) is submitted for approval of a drug, submits
a substantially complete application that contains and
lawfully maintains a certification described in paragraph
(2)(A)(vii)(IV) for the drug.
(cc) Substantially complete application.--As used in
this subsection, the term ``substantially complete
application'' means an application under this subsection
that on its face is sufficiently complete to permit a
substantive review and contains all the information required
by paragraph (2)(A).
(dd) Tentative approval.--
(AA) In general.--The term ``tentative approval''
means notification to an applicant by the Secretary that
an application under this subsection meets the
requirements of paragraph (2)(A), but cannot receive
effective approval because the application does not meet
the requirements of this subparagraph, there is a period
of exclusivity for the listed drug under subparagraph
(F) or section 355a of this title, or there is a 7-year
period of exclusivity for the listed drug under section
360cc of this title.
(BB) Limitation.--A drug that is granted tentative
approval by the Secretary is not an approved drug and
shall not have an effective approval until the Secretary
issues an approval after any necessary additional review
of the application.
(C) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement action.--
(I) In general.--No action may be brought under section 2201
of title 28 by an applicant under paragraph (2) for a
declaratory judgment with respect to a patent which is the
subject of the certification referred to in subparagraph
(B)(iii) unless--
(aa) the 45-day period referred to in such subparagraph
has expired;
(bb) neither the owner of such patent nor the holder of
the approved application under subsection (b) of this
section for the drug that is claimed by the patent or a use
of which is claimed by the patent brought a civil action
against the applicant for infringement of the patent before
the expiration of such period; and
(cc) in any case in which the notice provided under
paragraph (2)(B) relates to noninfringement, the notice was
accompanied by a document described in subclause (III).
(II) Filing of civil action.--If the conditions described in
items (aa), (bb), and as applicable, (cc) of subclause (I) have
been met, the applicant referred to in such subclause may, in
accordance with section 2201 of title 28, bring a civil action
under such section against the owner or holder referred to in
such subclause (but not against any owner or holder that has
brought such a civil action against the applicant, unless that
civil action was dismissed without prejudice) for a declaratory
judgment that the patent is invalid or will not be infringed by
the drug for which the applicant seeks approval, except that
such civil action may be brought for a declaratory judgment that
the patent will not be infringed only in a case in which the
condition described in subclause (I)(cc) is applicable. A civil
action referred to in this subclause shall be brought in the
judicial district where the defendant has its principal place of
business or a regular and established place of business.
(III) Offer of confidential access to application.--For
purposes of subclause (I)(cc), the document described in this
subclause is a document providing an offer of confidential
access to the application that is in the custody of the
applicant under paragraph (2) for the purpose of determining
whether an action referred to in subparagraph (B)(iii) should be
brought. The document providing the offer of confidential access
shall contain such restrictions as to persons entitled to
access, and on the use and disposition of any information
accessed, as would apply had a protective order been entered for
the purpose of protecting trade secrets and other confidential
business information. A request for access to an application
under an offer of confidential access shall be considered
acceptance of the offer of confidential access with the
restrictions as to persons entitled to access, and on the use
and disposition of any information accessed, contained in the
offer of confidential access, and those restrictions and other
terms of the offer of confidential access shall be considered
terms of an enforceable contract. Any person provided an offer
of confidential access shall review the application for the sole
and limited purpose of evaluating possible infringement of the
patent that is the subject of the certification under paragraph
(2)(A)(vii)(IV) and for no other purpose, and may not disclose
information of no relevance to any issue of patent infringement
to any person other than a person provided an offer of
confidential access. Further, the application may be redacted by
the applicant to remove any information of no relevance to any
issue of patent infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the patent or the holder of
the approved application under subsection (b) of this section
for the drug that is claimed by the patent or a use of which is
claimed by the patent brings a patent infringement action
against the applicant, the applicant may assert a counterclaim
seeking an order requiring the holder to correct or delete the
patent information submitted by the holder under subsection (b)
or (c) of this section on the ground that the patent does not
claim either--
(aa) the drug for which the application was approved; or
(bb) an approved method of using the drug.
(II) No independent cause of action.--Subclause (I) does not
authorize the assertion of a claim described in subclause (I) in
any civil action or proceeding other than a counterclaim
described in subclause (I).
(iii) No damages.--An applicant shall not be entitled to damages
in a civil action under clause (i) or a counterclaim under clause
(ii).
(D) Forfeiture of 180-day exclusivity period.--
(i) Definition of forfeiture event.--In this subparagraph, the
term ``forfeiture event'', with respect to an application under this
subsection, means the occurrence of any of the following:
(I) Failure to market.--The first applicant fails to market
the drug by the later of--
(aa) the earlier of the date that is--
(AA) 75 days after the date on which the approval of
the application of the first applicant is made effective
under subparagraph (B)(iii); or
(BB) 30 months after the date of submission of the
application of the first applicant; or
(bb) with respect to the first applicant or any other
applicant (which other applicant has received tentative
approval), the date that is 75 days after the date as of
which, as to each of the patents with respect to which the
first applicant submitted and lawfully maintained a
certification qualifying the first applicant for the 180-day
exclusivity period under subparagraph (B)(iv), at least 1 of
the following has occurred:
(AA) In an infringement action brought against that
applicant with respect to the patent or in a declaratory
judgment action brought by that applicant with respect
to the patent, a court enters a final decision from
which no appeal (other than a petition to the Supreme
Court for a writ of certiorari) has been or can be taken
that the patent is invalid or not infringed.
(BB) In an infringement action or a declaratory
judgment action described in subitem (AA), a court signs
a settlement order or consent decree that enters a final
judgment that includes a finding that the patent is
invalid or not infringed.
(CC) The patent information submitted under
subsection (b) or (c) of this section is withdrawn by
the holder of the application approved under subsection
(b) of this section.
(II) Withdrawal of application.--The first applicant
withdraws the application or the Secretary considers the
application to have been withdrawn as a result of a
determination by the Secretary that the application does not
meet the requirements for approval under paragraph (4).
(III) Amendment of certification.--The first applicant
amends or withdraws the certification for all of the patents
with respect to which that applicant submitted a certification
qualifying the applicant for the 180-day exclusivity period.
(IV) Failure to obtain tentative approval.--The first
applicant fails to obtain tentative approval of the application
within 30 months after the date on which the application is
filed, unless the failure is caused by a change in or a review
of the requirements for approval of the application imposed
after the date on which the application is filed.
(V) Agreement with another applicant, the listed drug
application holder, or a patent owner.--The first applicant
enters into an agreement with another applicant under this
subsection for the drug, the holder of the application for the
listed drug, or an owner of the patent that is the subject of
the certification under paragraph (2)(A)(vii)(IV), the Federal
Trade Commission or the Attorney General files a complaint, and
there is a final decision of the Federal Trade Commission or the
court with regard to the complaint from which no appeal (other
than a petition to the Supreme Court for a writ of certiorari)
has been or can be taken that the agreement has violated the
antitrust laws (as defined in section 12 of title 15, except
that the term includes section 45 of title 15 to the extent that
that section applies to unfair methods of competition).
(VI) Expiration of all patents.--All of the patents as to
which the applicant submitted a certification qualifying it for
the 180-day exclusivity period have expired.
(ii) Forfeiture.--The 180-day exclusivity period described in
subparagraph (B)(iv) shall be forfeited by a first applicant if a
forfeiture event occurs with respect to that first applicant.
(iii) Subsequent applicant.--If all first applicants forfeit the
180-day exclusivity period under clause (ii)--
(I) approval of any application containing a certification
described in paragraph (2)(A)(vii)(IV) shall be made effective
in accordance with subparagraph (B)(iii); and
(II) no applicant shall be eligible for a 180-day
exclusivity period.
(E) If the Secretary decides to disapprove an application, the
Secretary shall give the applicant notice of an opportunity for a
hearing before the Secretary on the question of whether such application
is approvable. If the applicant elects to accept the opportunity for
hearing by written request within thirty days after such notice, such
hearing shall commence not more than ninety days after the expiration of
such thirty days unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an expedited basis and
the Secretary's order thereon shall be issued within ninety days after
the date fixed by the Secretary for filing final briefs.
(F)(i) If an application (other than an abbreviated new drug
application) submitted under subsection (b) of this section for a drug,
no active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application under
subsection (b) of this section, was approved during the period beginning
January 1, 1982, and ending on September 24, 1984, the Secretary may not
make the approval of an application submitted under this subsection
which refers to the drug for which the subsection (b) application was
submitted effective before the expiration of ten years from the date of
the approval of the application under subsection (b) of this section.
(ii) If an application submitted under subsection (b) of this
section for a drug, no active ingredient (including any ester or salt of
the active ingredient) of which has been approved in any other
application under subsection (b) of this section, is approved after
September 24,
1984, no application may be submitted under this subsection which refers
to the drug for which the subsection (b) application was submitted
before the expiration of five years from the date of the approval of the
application under subsection (b) of this section, except that such an
application may be submitted under this subsection after the expiration
of four years from the date of the approval of the subsection (b)
application if it contains a certification of patent invalidity or
noninfringement described in subclause (IV) of paragraph (2)(A)(vii).
The approval of such an application shall be made effective in
accordance with subparagraph (B) except that, if an action for patent
infringement is commenced during the one-year period beginning forty-
eight months after the date of the approval of the subsection (b)
application, the thirty-month period referred to in subparagraph
(B)(iii) shall be extended by such amount of time (if any) which is
required for seven and one-half years to have elapsed from the date of
approval of the subsection (b) application.
(iii) If an application submitted under subsection (b) of this
section for a drug, which includes an active ingredient (including any
ester or salt of the active ingredient) that has been approved in
another application approved under subsection (b) of this section, is
approved after September 24, 1984, and if such application contains
reports of new clinical investigations (other than bioavailability
studies) essential to the approval of the application and conducted or
sponsored by the applicant, the Secretary may not make the approval of
an application submitted under this subsection for the conditions of
approval of such drug in the subsection (b) application effective before
the expiration of three years from the date of the approval of the
application under subsection (b) of this section for such drug.
(iv) If a supplement to an application approved under subsection (b)
of this section is approved after September 24, 1984, and the supplement
contains reports of new clinical investigations (other than
bioavailability studies) essential to the approval of the supplement and
conducted or sponsored by the person submitting the supplement, the
Secretary may not make the approval of an application submitted under
this subsection for a change approved in the supplement effective before
the expiration of three years from the date of the approval of the
supplement under subsection (b) of this section.
(v) If an application (or supplement to an application) submitted
under subsection (b) of this section for a drug, which includes an
active ingredient (including any ester or salt of the active ingredient)
that has been approved in another application under subsection (b) of
this section, was approved during the period beginning January 1, 1982,
and ending on September 24, 1984, the Secretary may not make the
approval of an application submitted under this subsection which refers
to the drug for which the subsection (b) application was submitted or
which refers to a change approved in a supplement to the subsection (b)
application effective before the expiration of two years from September
24, 1984.
(6) If a drug approved under this subsection refers in its approved
application to a drug the approval of which was withdrawn or suspended
for grounds described in the first sentence of subsection (e) of this
section or was withdrawn or suspended under this paragraph or which, as
determined by the Secretary, has been withdrawn from sale for safety or
effectiveness reasons, the approval of the drug under this subsection
shall be withdrawn or suspended--
(A) for the same period as the withdrawal or suspension under
subsection (e) of this section or this paragraph, or
(B) if the listed drug has been withdrawn from sale, for the
period of withdrawal from sale or, if earlier, the period ending on
the date the Secretary determines that the withdrawal from sale is
not for safety or effectiveness reasons.
(7)(A)(i) Within sixty days of September 24, 1984, the Secretary
shall publish and make available to the public--
(I) a list in alphabetical order of the official and proprietary
name of each drug which has been approved for safety and
effectiveness under subsection (c) of this section before September
24, 1984;
(II) the date of approval if the drug is approved after 1981 and
the number of the application which was approved; and
(III) whether in vitro or in vivo bioequivalence studies, or
both such studies, are required for applications filed under this
subsection which will refer to the drug published.
(ii) Every thirty days after the publication of the first list under
clause (i) the Secretary shall revise the list to include each drug
which has been approved for safety and effectiveness under subsection
(c) of this section or approved under this subsection during the thirty-
day period.
(iii) When patent information submitted under subsection (b) or (c)
of this section respecting a drug included on the list is to be
published by the Secretary, the Secretary shall, in revisions made under
clause (ii), include such information for such drug.
(B) A drug approved for safety and effectiveness under subsection
(c) of this section or approved under this subsection shall, for
purposes of this subsection, be considered to have been published under
subparagraph (A) on the date of its approval or September 24, 1984,
whichever is later.
(C) If the approval of a drug was withdrawn or suspended for grounds
described in the first sentence of subsection (e) of this section or was
withdrawn or suspended under paragraph (6) or if the Secretary
determines that a drug has been withdrawn from sale for safety or
effectiveness reasons, it may not be published in the list under
subparagraph (A) or, if the withdrawal or suspension occurred after its
publication in such list, it shall be immediately removed from such
list--
(i) for the same period as the withdrawal or suspension under
subsection (e) of this section or paragraph (6), or
(ii) if the listed drug has been withdrawn from sale, for the
period of withdrawal from sale or, if earlier, the period ending on
the date the Secretary determines that the withdrawal from sale is
not for safety or effectiveness reasons.
A notice of the removal shall be published in the Federal Register.
(8) For purposes of this subsection:
(A)(i) The term ``bioavailability'' means the rate and extent to
which the active ingredient or therapeutic ingredient is absorbed
from a drug and becomes available at the site of drug action.
(ii) For a drug that is not intended to be absorbed into the
bloodstream, the Secretary may assess bioavailability by
scientifically valid measurements intended to reflect the rate and
extent to which the active ingredient or therapeutic ingredient
becomes available at the site of drug action.
(B) A drug shall be considered to be bioequivalent to a listed
drug if--
(i) the rate and extent of absorption of the drug do not
show a significant difference from the rate and extent of
absorption of the listed drug when administered at the same
molar dose of the therapeutic ingredient under similar
experimental conditions in either a single dose or multiple
doses; or
(ii) the extent of absorption of the drug does not show a
significant difference from the extent of absorption of the
listed drug when administered at the same molar dose of the
therapeutic ingredient under similar experimental conditions in
either a single dose or multiple doses and the difference from
the listed drug in the rate of absorption of the drug is
intentional, is reflected in its proposed labeling, is not
essential to the attainment of effective body drug
concentrations on chronic use, and is considered medically
insignificant for the drug.
(C) For a drug that is not intended to be absorbed into the
bloodstream, the Secretary may establish alternative, scientifically
valid methods to show bioequivalence if the alternative methods are
expected to detect a significant difference between the drug and the
listed drug in safety and therapeutic effect.
(9) The Secretary shall, with respect to each application submitted
under this subsection, maintain a record of--
(A) the name of the applicant,
(B) the name of the drug covered by the application,
(C) the name of each person to whom the review of the chemistry
of the application was assigned and the date of such assignment, and
(D) the name of each person to whom the bioequivalence review
for such application was assigned and the date of such assignment.
The information the Secretary is required to maintain under this
paragraph with respect to an application submitted under this subsection
shall be made available to the public after the approval of such
application.
(k) Records and reports; required information; regulations and orders;
access to records
(1) In the case of any drug for which an approval of an application
filed under subsection (b) or (j) of this section is in effect, the
applicant shall establish and maintain such records, and make such
reports to the Secretary, of data relating to clinical experience and
other data or information, received or otherwise obtained by such
applicant with respect to such drug, as the Secretary may by general
regulation, or by order with respect to such application, prescribe on
the basis of a finding that such records and reports are necessary in
order to enable the Secretary to determine, or facilitate a
determination, whether there is or may be ground for invoking subsection
(e) of this section. Regulations and orders issued under this subsection
and under subsection (i) of this section shall have due regard for the
professional ethics of the medical profession and the interests of
patients and shall provide, where the Secretary deems it to be
appropriate, for the examination, upon request, by the persons to whom
such regulations or orders are applicable, of similar information
received or otherwise obtained by the Secretary.
(2) Every person required under this section to maintain records,
and every person in charge or custody thereof, shall, upon request of an
officer or employee designated by the Secretary, permit such officer or
employee at all reasonable times to have access to and copy and verify
such records.
(l) Public disclosure of safety and effectiveness data
Safety and effectiveness data and information which has been
submitted in an application under subsection (b) of this section for a
drug and which has not previously been disclosed to the public shall be
made available to the public, upon request, unless extraordinary
circumstances are shown--
(1) if no work is being or will be undertaken to have the
application approved,
(2) if the Secretary has determined that the application is not
approvable and all legal appeals have been exhausted,
(3) if approval of the application under subsection (c) of this
section is withdrawn and all legal appeals have been exhausted,
(4) if the Secretary has determined that such drug is not a new
drug, or
(5) upon the effective date of the approval of the first
application under subsection (j) of this section which refers to
such drug or upon the date upon which the approval of an application
under subsection (j) of this section which refers to such drug could
be made effective if such an application had been submitted.
(m) ``Patent'' defined
For purposes of this section, the term ``patent'' means a patent
issued by the United States Patent and Trademark Office.
(n) Scientific advisory panels
(1) For the purpose of providing expert scientific advice and
recommendations to the Secretary regarding a clinical investigation of a
drug or the approval for marketing of a drug under this section or
section 262 of title 42, the Secretary shall establish panels of experts
or use panels of experts established before November 21, 1997, or both.
(2) The Secretary may delegate the appointment and oversight
authority granted under section 394 of this title to a director of a
center or successor entity within the Food and Drug Administration.
(3) The Secretary shall make appointments to each panel established
under paragraph (1) so that each panel shall consist of--
(A) members who are qualified by training and experience to
evaluate the safety and effectiveness of the drugs to be referred to
the panel and who, to the extent feasible, possess skill and
experience in the development, manufacture, or utilization of such
drugs;
(B) members with diverse expertise in such fields as clinical
and administrative medicine, pharmacy, pharmacology,
pharmacoeconomics, biological and physical sciences, and other
related professions;
(C) a representative of consumer interests, and a representative
of interests of the drug manufacturing industry not directly
affected by the matter to be brought before the panel; and
(D) two or more members who are specialists or have other
expertise in the particular disease or condition for which the drug
under review is proposed to be indicated.
Scientific, trade, and consumer organizations shall be afforded an
opportunity to nominate individuals for appointment to the panels. No
individual who is in the regular full-time employ of the United States
and engaged in the administration of this chapter may be a voting member
of any panel. The Secretary shall designate one of the members of each
panel to serve as chairman thereof.
(4) Each member of a panel shall publicly disclose all conflicts of
interest that member may have with the work to be undertaken by the
panel. No member of a panel may vote on any matter where the member or
the immediate family of such member could gain financially from the
advice given to the Secretary. The Secretary may grant a waiver of any
conflict of interest requirement upon public disclosure of such conflict
of interest if such waiver is necessary to afford the panel essential
expertise, except that the Secretary may not grant a waiver for a member
of a panel when the member's own scientific work is involved.
(5) The Secretary shall, as appropriate, provide education and
training to each new panel member before such member participates in a
panel's activities, including education regarding requirements under
this chapter and related regulations of the Secretary, and the
administrative processes and procedures related to panel meetings.
(6) Panel members (other than officers or employees of the United
States), while attending meetings or conferences of a panel or otherwise
engaged in its business, shall be entitled to receive compensation for
each day so engaged, including traveltime, at rates to be fixed by the
Secretary, but not to exceed the daily equivalent of the rate in effect
for positions classified above grade GS-15 of the General Schedule.
While serving away from their homes or regular places of business, panel
members may be allowed travel expenses (including per diem in lieu of
subsistence) as authorized by section 5703 of title 5, for persons in
the Government service employed intermittently.
(7) The Secretary shall ensure that scientific advisory panels meet
regularly and at appropriate intervals so that any matter to be reviewed
by such a panel can be presented to the panel not more than 60 days
after the matter is ready for such review. Meetings of the panel may be
held using electronic communication to convene the meetings.
(8) Within 90 days after a scientific advisory panel makes
recommendations on any matter under its review, the Food and Drug
Administration official responsible for the matter shall review the
conclusions and recommendations of the panel, and notify the affected
persons of the final decision on the matter, or of the reasons that no
such decision has been reached. Each such final decision shall be
documented including the rationale for the decision.
(June 25, 1938, ch. 675, Sec. 505, 52 Stat. 1052; Pub. L. 86-507,
Sec. 1(18), June 11, 1960, 74 Stat. 201; Pub. L. 87-781, title I,
Secs. 102(b)-(d), 103(a), (b), 104(a)-(d)(2), Oct. 10, 1962, 76
Stat. 781-783, 784, 785; Pub. L. 92-387, Sec. 4(d), Aug. 16, 1972, 86
Stat. 562; Pub. L. 98-417, title I, Secs. 101, 102(a)-(b)(5), 103,
104, Sept. 24, 1984, 98 Stat. 1585, 1592, 1593, 1597; Pub. L. 102-282,
Sec. 5, May 13, 1992, 106 Stat. 161; Pub. L. 103-80, Sec. 3(n), Aug. 13,
1993, 107 Stat. 777; Pub. L. 105-115, title I, Secs. 115, 117, 119,
120, 124(a), Nov. 21, 1997, 111 Stat. 2313, 2315, 2316, 2318, 2324; Pub.
L. 106-113, div. B, Sec. 1000(a)(9) [title IV, Sec. 4732(b)(11)], Nov.
29, 1999, 113 Stat. 1536, 1501A-584; Pub. L. 107-109, Sec. 15(c)(1),
Jan. 4, 2002, 115 Stat. 1420; Pub. L. 108-155, Sec. 2(b)(1), Dec. 3,
2003, 117 Stat. 1941; Pub. L. 108-173, title XI, Secs. 1101(a), (b),
1102(a), 1103(a), Dec. 8, 2003, 117 Stat. 2448, 2452, 2457, 2460.)
References in Text
The General Schedule, referred to in subsec. (n)(6), is set out
under section 5332 of Title 5, Government Organization and Employees.
Amendments
2003--Subsec. (b)(1). Pub. L. 108-155, in second sentence,
substituted ``(F)'' for ``and (F)'' and inserted ``, and (G) any
assessments required under section 355c of this title'' before period at
end.
Subsec. (b)(3). Pub. L. 108-173, Sec. 1101(b)(1)(A), added par. (3)
and struck out former par. (3) which, in subpar. (A), required an
applicant making a certification under par. (2)(A)(iv) to include
statement that applicant will give notice to each owner of the patent
which is the subject of the certification and to the holder of the
approved application, in subpar. (B), directed that notice state that an
application has been submitted and include a detailed statement of the
applicant's opinion that the patent is not valid or will not be
infringed, and, in subpar. (C), provided that if an application is
amended, notice shall be given when the amended application is
submitted.
Subsec. (b)(4), (5). Pub. L. 108-173, Sec. 1101(b)(1)(B), added par.
(4) and redesignated former par. (4) as (5).
Subsec. (c)(3). Pub. L. 108-173, Sec. 1101(b)(2)(A), substituted
``by applying the following to each certification made under subsection
(b)(2)(A) of this section'' for ``under the following'' in introductory
provisions.
Subsec. (c)(3)(C). Pub. L. 108-173, Sec. 1101(b)(2)(B)(iii), which
directed the substitution of ``subsection (b)(3) of this section'' for
``paragraph (3)(B)'' in third sentence, could not be executed because
such words do not appear. See note below.
Pub. L. 108-173, Sec. 1101(b)(2)(B)(ii)(VI), in concluding
provisions, struck out ``Until the expiration of forty-five days from
the date the notice made under paragraph (3)(B) is received, no action
may be brought under section 2201 of title 28 for a declaratory judgment
with respect to the patent. Any action brought under
such section 2201 shall be brought in the judicial district where the
defendant has its principal place of business or a regular and
established place of business.'' after ``expediting the action.''
Pub. L. 108-173, Sec. 1101(b)(2)(B)(i), (ii)(I), in first sentence
of introductory provisions, substituted ``unless, before the expiration
of 45 days after the date on which the notice described in subsection
(b)(3) of this section is received, an action is brought for
infringement of the patent that is the subject of the certification and
for which information was submitted to the Secretary under paragraph (2)
or subsection (b)(1) of this section before the date on which the
application (excluding an amendment or supplement to the application)
was submitted'' for ``unless an action is brought for infringement of a
patent which is the subject of the certification before the expiration
of forty-five days from the date the notice provided under paragraph
(3)(B) is received'' and, in second sentence of introductory provisions,
substituted ``subsection (b)(3) of this section'' for ``paragraph
(3)(B)''.
Subsec. (c)(3)(C)(i). Pub. L. 108-173, Sec. 1101(b)(2)(B)(ii)(II),
added cl. (i) and struck out former cl. (i) which read as follows: ``if
before the expiration of such period the court decides that such patent
is invalid or not infringed, the approval may be made effective on the
date of the court decision,''.
Subsec. (c)(3)(C)(ii). Pub. L. 108-173, Sec. 1101(b)(2)(B)(ii)(III),
added cl. (ii) and struck out former cl. (ii) which read as follows:
``if before the expiration of such period the court decides that such
patent has been infringed, the approval may be made effective on such
date as the court orders under section 271(e)(4)(A) of title 35, or''.
Subsec. (c)(3)(C)(iii). Pub. L. 108-173, Sec. 1101(b)(2)(B)(ii)(IV),
substituted ``as provided in clause (i); or'' for ``on the date of such
court decision.''
Subsec. (c)(3)(C)(iv). Pub. L. 108-173, Sec. 1101(b)(2)(B)(ii)(V),
added cl. (iv).
Subsec. (c)(3)(D), (E). Pub. L. 108-173, Sec. 1101(b)(2)(C), (D),
added subpar. (D) and redesignated former subpar. (D) as (E).
Subsec. (j)(2)(B). Pub. L. 108-173, Sec. 1101(a)(1)(A), added
subpar. (B) and struck out former subpar. (B) which, in cl. (i),
required that an applicant making a certification under subpar.
(A)(vii)(IV) include in the application a statement that notice would be
given to each owner of the patent and the holder of the approved
application, in cl. (ii), required that notice would state that an
application had been submitted and that it would include a detailed
statement of the basis of the applicant's opinion, and, in cl. (iii),
directed that notice of an amended application be given when the amended
application had been submitted.
Subsec. (j)(2)(D). Pub. L. 108-173, Sec. 1101(a)(1)(B), added
subpar. (D).
Subsec. (j)(5)(B). Pub. L. 108-173, Sec. 1101(a)(2)(A)(i),
substituted ``by applying the following to each certification made under
paragraph (2)(A)(vii)'' for ``under the following'' in introductory
provisions.
Subsec. (j)(5)(B)(iii). Pub. L. 108-173,
Sec. 1101(a)(2)(A)(ii)(II)(ee), which directed amendment of the second
sentence of subsec. (j)(5)(B)(iii) by striking ``Until the expiration''
and all that follows in the matter after and below subclause (IV), was
executed by striking ``Until the expiration of forty-five days from the
date the notice made under paragraph (2)(B)(i) is received, no action
may be brought under section 2201 of title 28, for a declaratory
judgment with respect to the patent. Any action brought under section
2201 shall be brought in the judicial district where the defendant has
its principal place of business or a regular and established place of
business.'' after ``expediting the action.'' in concluding provisions,
to reflect the probable intent of Congress.
Pub. L. 108-173, Sec. 1101(a)(2)(A)(ii)(I), in introductory
provisions, substituted ``unless, before the expiration of 45 days after
the date on which the notice described in paragraph (2)(B) is received,
an action is brought for infringement of the patent that is the subject
of the certification and for which information was submitted to the
Secretary under subsection (b)(1) or (c)(2) of this section before the
date on which the application (excluding an amendment or supplement to
the application), which the Secretary later determines to be
substantially complete, was submitted'' for ``unless an action is
brought for infringement of a patent which is the subject of the
certification before the expiration of forty-five days from the date the
notice provided under paragraph (2)(B)(i) is received''.
Subsec. (j)(5)(B)(iii)(I). Pub. L. 108-173,
Sec. 1101(a)(2)(A)(ii)(II)(aa), added subcl. (I) and struck out former
subcl. (I) which read as follows: ``if before the expiration of such
period the court decides that such patent is invalid or not infringed,
the approval shall be made effective on the date of the court
decision,''.
Subsec. (j)(5)(B)(iii)(II). Pub. L. 108-173,
Sec. 1101(a)(2)(A)(ii)(II)(bb), added subcl. (II) and struck out former
subcl. (II) which read as follows: ``if before the expiration of such
period the court decides that such patent has been infringed, the
approval shall be made effective on such date as the court orders under
section 271(e)(4)(A) of title 35, or''.
Subsec. (j)(5)(B)(iii)(III). Pub. L. 108-173,
Sec. 1101(a)(2)(A)(ii)(II)(cc), substituted ``as provided in subclause
(I); or'' for ``on the date of such court decision.''
Subsec. (j)(5)(B)(iii)(IV). Pub. L. 108-173,
Sec. 1101(a)(2)(A)(ii)(II)(dd), added subcl. (IV).
Subsec. (j)(5)(B)(iv). Pub. L. 108-173, Sec. 1102(a)(1), added cl.
(iv) and struck out former cl. (iv) which read as follows: ``If the
application contains a certification described in subclause (IV) of
paragraph (2)(A)(vii) and is for a drug for which a previous application
has been submitted under this subsection continuing such a
certification, the application shall be made effective not earlier than
one hundred and eighty days after--
``(I) the date the Secretary receives notice from the applicant
under the previous application of the first commercial marketing of
the drug under the previous application, or
``(II) the date of a decision of a court in an action described
in clause (iii) holding the patent which is the subject of the
certification to be invalid or not infringed,
whichever is earlier.''
Subsec. (j)(5)(C). Pub. L. 108-173, Sec. 1101(a)(2)(B), (C), added
subpar. (C). Former subpar. (C) redesignated (E).
Subsec. (j)(5)(D). Pub. L. 108-173, Sec. 1102(a)(2), added subpar.
(D).
Pub. L. 108-173, Sec. 1101(a)(2)(B), redesignated subpar. (D) as
(F).
Subsec. (j)(5)(E), (F). Pub. L. 108-173, Sec. 1101(a)(2)(B),
redesignated subpars. (C) and (D) as (E) and (F), respectively.
Subsec. (j)(8)(A). Pub. L. 108-173, Sec. 1103(a)(1), added subpar.
(A) and struck out former subpar. (A) which read as follows: ``The term
`bioavailability' means the rate and extent to which the active
ingredient or therapeutic ingredient is absorbed from a drug and becomes
available at the site of drug action.''
Subsec. (j)(8)(C). Pub. L. 108-173, Sec. 1103(a)(2), added subpar.
(C).
2002--Subsec. (i)(1)(D). Pub. L. 107-109 added subpar. (D).
1999--Subsec. (m). Pub. L. 106-113 substituted ``United States
Patent and Trademark Office'' for ``Patent and Trademark Office of the
Department of Commerce''.
1997--Subsec. (b)(1). Pub. L. 105-115, Sec. 115(b), inserted at end
``The Secretary shall, in consultation with the Director of the National
Institutes of Health and with representatives of the drug manufacturing
industry, review and develop guidance, as appropriate, on the inclusion
of women and minorities in clinical trials required by clause (A).''
Subsec. (b)(4). Pub. L. 105-115, Sec. 119(a), added par. (4).
Subsec. (c)(4). Pub. L. 105-115, Sec. 124(a), added par. (4).
Subsec. (d). Pub. L. 105-115, Sec. 115(a), inserted at end ``If the
Secretary determines, based on relevant science, that data from one
adequate and well-con
trolled clinical investigation and confirmatory evidence (obtained prior
to or after such investigation) are sufficient to establish
effectiveness, the Secretary may consider such data and evidence to
constitute substantial evidence for purposes of the preceding
sentence.''
Subsec. (i). Pub. L. 105-115, Sec. 117, inserted ``(1)'' after
``(i)'', redesignated former pars. (1) to (3) as subpars. (A) to (C),
respectively, of par. (1), added pars. (2) to (4), and struck out
closing provisions which read as follows: ``Such regulations shall
provide that such exemption shall be conditioned upon the manufacturer,
or the sponsor of the investigation, requiring that experts using such
drugs for investigational purposes certify to such manufacturer or
sponsor that they will inform any human beings to whom such drugs, or
any controls used in connection therewith, are being administered, or
their representatives, that such drugs are being used for
investigational purposes and will obtain the consent of such human
beings or their representatives, except where they deem it not feasible
or, in their professional judgment, contrary to the best interests of
such human beings. Nothing in this subsection shall be construed to
require any clinical investigator to submit directly to the Secretary
reports on the investigational use of drugs.''
Subsec. (j)(2)(A)(i). Pub. L. 105-115, Sec. 119(b)(2)(A),
substituted ``paragraph (7)'' for ``paragraph (6)''.
Subsec. (j)(3). Pub. L. 105-115, Sec. 119(b)(1)(B), added par. (3).
Former par. (3) redesignated (4).
Subsec. (j)(4). Pub. L. 105-115, Sec. 119(b)(1)(A), (2)(B),
redesignated par. (3) as (4) and in introductory provisions substituted
``paragraph (5)'' for ``paragraph (4)''. Former par. (4) redesignated
(5).
Subsec. (j)(4)(I). Pub. L. 105-115, Sec. 119(b)(2)(C), substituted
``paragraph (6)'' for ``paragraph (5)''.
Subsec. (j)(5), (6). Pub. L. 105-115, Sec. 119(b)(1)(A),
redesignated pars. (4) and (5) as (5) and (6), respectively. Former par.
(6) redesignated (7).
Subsec. (j)(7). Pub. L. 105-115, Sec. 119(b)(1)(A), (2)(D),
redesignated par. (6) as (7) and in subpar. (C) substituted ``paragraph
(6)'' for ``paragraph (5)'' in two places. Former par. (7) redesignated
(8).
Subsec. (j)(8), (9). Pub. L. 105-115, Sec. 119(b)(1)(A),
redesignated pars. (7) and (8) as (8) and (9), respectively.
Subsec. (n). Pub. L. 105-115, Sec. 120, added subsec. (n).
1993--Subsec. (j)(6)(A)(ii). Pub. L. 103-80, Sec. 3(n)(1)(A),
substituted ``Secretary'' for ``Secretry''.
Subsec. (j)(6)(A)(iii). Pub. L. 103-80, Sec. 3(n)(1)(B), inserted
comma after ``published by the Secretary''.
Subsec. (k)(1). Pub. L. 103-80, Sec. 3(n)(2), substituted ``section.
Regulations'' for ``section: Provided, however, That regulations''.
1992--Subsec. (j)(8). Pub. L. 102-282 added par. (8).
1984--Subsec. (a). Pub. L. 98-417, Sec. 102(b)(1), inserted ``or
(j)'' after ``subsection (b)''.
Subsec. (b). Pub. L. 98-417, Secs. 102(a)(1), 103(a), designated
existing provisions of subsec. (b) as par. (1) thereof and redesignated
existing cls. (1) through (6) of such par. (1) as cls. (A) through (F)
thereof, respectively, inserted requirement that the applicant file with
the application the patent number and the expiration date of any patent
which claims the drug for which the applicant submitted the application
or which claims a method of using such drug and with respect to which a
claim of patent infringement could reasonably by asserted if a person
not licensed by the owner engaged in the manufacture, use, or sale of
the drug, that the applicant amend the application to include such
information if an application is filed under this subsection for a drug
and a patent which claims such drug or a method of using such drug is
issued after the filing date but before approval of the application, and
that upon approval of the application, the Secretary publish the
information submitted, and added pars. (2) and (3).
Subsec. (c). Pub. L. 98-417, Secs. 102(a)(2), (b)(2), 103(b),
designated existing provisions of subsec. (c) as par. (1) thereof and in
par. (1) as so designated substituted ``subsection (b) of this section''
for ``this subsection'' and redesignated former pars. (1) and (2) as
subpars. (A) and (B), respectively, and added pars. (2) and (3).
Subsec. (d)(6), (7). Pub. L. 98-417, Sec. 102(a)(3)(A), added cl.
(6) relating to the failure of the application to contain the patent
information prescribed by subsec. (b) of this section, and redesignated
former cl. (6) as (7).
Subsec. (e). Pub. L. 98-417, Sec. 102(a)(3)(B), in first sentence,
added a new cl. (4) relating to the failure to file the patent
information prescribed by subsec. (c) of this section within 30 days
after the receipt of written notice from the Secretary specifying the
failure to file such information, and redesignated former cl. (4) as
(5).
Pub. L. 98-417, Sec. 102(b)(3), (4), in second sentence, inserted in
provisions preceding cl. (1) ``submitted under subsection (b) or (j) of
this section'' and in cl. (1) substituted ``under subsection (k) of this
section or to comply with the notice requirements of section 360(k)(2)
of this title'' for ``under subsection (j) of this section or to comply
with the notice requirements of section 360(j)(2) of this title''.
Subsecs. (j), (k). Pub. L. 98-417, Sec. 101, added subsec. (j) and
redesignated former subsec. (j) as (k).
Subsec. (k)(1). Pub. L. 98-417, Sec. 102(b)(5), substituted ``under
subsection (b) or (j) of this section'' for ``pursuant to this
section''.
Subsecs. (l), (m). Pub. L. 98-417, Sec. 104, added subsecs. (l) and
(m).
1972--Subsec. (e). Pub. L. 92-387 inserted ``or to comply with the
notice requirements of section 360(j)(2) of this title'' in cl. (1) of
second sentence relating to the maintenance of records.
1962--Subsec. (a). Pub. L. 87-781, Sec. 104(a), inserted ``an
approval of'' before ``an application''.
Subsec. (b). Pub. L. 87-781, Sec. 102(b), inserted ``and whether
such drug is effective in use'' after ``is safe for use''.
Subsec. (c). Pub. L. 87-781, Sec. 104(b), substituted provisions
requiring the Secretary, within 180 days after filing an application, or
such additional period as the Secretary and the applicant agree upon, to
either approve the application, if meeting the requirements of subsec.
(d) of this section, or give notice of opportunity for hearing on
question of whether such application is approvable, and providing that
if applicant requests hearing in writing within 30 days, the hearing
shall begin within 90 days after expiration of said 30 days, unless the
Secretary and applicant agree otherwise, that such hearing shall be
expedited, and that the Secretary's order shall be issued within 90 days
after date for filing final briefs, for provisions which had an
application become effective on the sixtieth day after filing thereof
unless prior thereto the Secretary postponed the date by written notice
to such time, but not more than 180 days after filing, as the Secretary
deemed necessary to study and investigate the application.
Subsec. (d). Pub. L. 87-781, Sec. 102(c), inserted references to
subsec. (c), added cls. (5) and (6), provided that if after notice and
opportunity for hearing, the Secretary finds that cls. (1) to (6) do not
apply, he shall approve the application, and defined ``substantial
evidence'' as used in this subsection and subsec. (e) of this section.
Subsec. (e). Pub. L. 87-781, Sec. 102(d), amended subsec. (e)
generally, and among other changes, directed the Secretary to withdraw
approval of an application if by tests, other scientific data or
experience, or new evidence of clinical experience not contained in the
application or available at the time of its approval, the drug is shown
to be unsafe, or on the basis of new information, there is shown a lack
of substantial evidence that the drug has the effect it is represented
to have, and provided that if the Secretary, or acting Secretary, finds
there is an imminent hazard to the public health, he may suspend
approval immediately, notify the applicant, and give him opportunity for
an expedited hearing, that the Secretary may withdraw approval if the
applicant fails to establish a system for maintaining required records,
or has repeatedly or deliberately failed to maintain records and make
reports, or has refused access to, or copying or verification of such
records, or if the Secretary finds on new evidence that the methods,
facilities and controls in the manufacturing, processing, and packing
are inadequate to assure
and preserve the drugs' identity, strength, quality and purity, and were
not made adequate within a reasonable time after receipt of written
notice thereof, or finds on new evidence, that the labeling is false or
misleading and was not corrected within a reasonable time after receipt
of written notice thereof.
Subsec. (f). Pub. L. 87-781, Sec. 104(c), substituted provisions
requiring the Secretary to revoke any previous order under subsecs. (d)
or (e) of this section refusing, withdrawing, or suspending approval of
an application and to approve such application or reinstate such
approval, for provisions which required him to revoke an order refusing
effectiveness to an application.
Subsec. (h). Pub. L. 87-781, Sec. 104(d)(1), (2), inserted ``as
provided in section 2112 of title 28'', and ``except that until the
filing of the record the Secretary may modify or set aside his order'',
substituted ``or withdrawing approval of an application under this
section'' for ``to permit the application to become effective, or
suspending the effectiveness of the application'', ``United States court
of appeals for the circuit'' for ``district court of the United States
within any district'', ``Court of Appeals for the District of Columbia
Circuit'' for ``District Court for the District of Columbia'',
``transmitted by the clerk of the court to'' for ``served upon'', and
``by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28'' for ``as
provided in sections 225, 346, and 347 of title 28, as amended, and in
section 7, as amended, of the Act entitled `An Act to establish a Court
of Appeals for the District of Columbia', approved February 9, 1893'',
and eliminated ``upon'' before ``any officer designated'', ``a
transcript of'' before ``the record'' and ``and decree'' before ``of the
court affirming''.
Subsec. (i). Pub. L. 87-781, Sec. 103(b), inserted ``the foregoing
subsections of'' after ``operation of'', and ``and effectiveness'' after
``safety'', and provided that the regulations may condition exemptions
upon the submission of reports of preclinical tests to justify the
proposed clinical testing, upon the obtaining by the manufacturer or
sponsor of the investigation of a new drug of a signed agreement from
each of the investigators that patients to whom the drug is administered
will be under his supervision or under investigators responsible to him,
and that he will not supply such drug to any other investigator, or to
clinics, for administration to human beings, or upon the establishment
and maintenance of records and reports of data obtained by the
investigational use of such drug, as the Secretary finds will enable him
to evaluate the safety and effectiveness of such drug, and provided that
the regulations shall condition an exemption upon the manufacturer or
sponsor of the investigation requiring that experts using such drugs
certify that they will inform humans to whom such drugs or any controls
connected therewith are administered, or their representatives, and will
obtain the consent of such people where feasible and not contrary to the
best interests of such people, and that reports on the investigational
use of drugs are not required to be submitted directly to the Secretary.
Subsec. (j). Pub. L. 87-781, Sec. 103(a), added subsec. (j).
1960--Subsec. (g). Pub. L. 86-507 inserted ``or by certified mail''
after ``registered mail''.
Effective Date of 2003 Amendments
Pub. L. 108-173, title XI, Sec. 1101(c), Dec. 8, 2003, 117 Stat.
2456, provided that:
``(1) In general.--Except as provided in paragraphs (2) and (3), the
amendments made by subsections (a) and (b) [amending this section] apply
to any proceeding under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) that is pending on or after the date of the
enactment of this Act [Dec. 8, 2003] regardless of the date on which the
proceeding was commenced or is commenced.
``(2) Notice of opinion that patent is invalid or will not be
infringed.--The amendments made by subsections (a)(1) and (b)(1) apply
with respect to any certification under subsection (b)(2)(A)(iv) or
(j)(2)(A)(vii)(IV) of section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) submitted on or after August 18, 2003, in
an application filed under subsection (b) or (j) of that section or in
an amendment or supplement to an application filed under subsection (b)
or (j) of that section.
``(3) Effective date of approval.--The amendments made by
subsections (a)(2)(A)(ii)(I) and (b)(2)(B)(i) apply with respect to any
patent information submitted under subsection (b)(1) or (c)(2) of
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)
on or after August 18, 2003.''
Pub. L. 108-173, title XI, Sec. 1102(b), Dec. 8, 2003, 117 Stat.
2460, provided that:
``(1) In general.--Except as provided in paragraph (2), the
amendment made by subsection (a) [amending this section] shall be
effective only with respect to an application filed under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the
date of the enactment of this Act [Dec. 8, 2003] for a listed drug for
which no certification under section 505(j)(2)(A)(vii)(IV) of that Act
was made before the date of the enactment of this Act.
``(2) Collusive agreements.--If a forfeiture event described in
section 505(j)(5)(D)(i)(V) of that Act occurs in the case of an
applicant, the applicant shall forfeit the 180-day period under section
505(j)(5)(B)(iv) of that Act without regard to when the first
certification under section 505(j)(2)(A)(vii)(IV) of that Act for the
listed drug was made.
``(3) Decision of a court when the 180-day exclusivity period has
not been triggered.--With respect to an application filed before, on, or
after the date of the enactment of this Act [Dec. 8, 2003] for a listed
drug for which a certification under section 505(j)(2)(A)(vii)(IV) of
that Act was made before the date of the enactment of this Act and for
which neither of the events described in subclause (I) or (II) of
section 505(j)(5)(B)(iv) of that Act (as in effect on the day before the
date of the enactment of this Act) has occurred on or before the date of
the enactment of this Act, the term `decision of a court' as used in
clause (iv) of section 505(j)(5)(B) of that Act means a final decision
of a court from which no appeal (other than a petition to the Supreme
Court for a writ of certiorari) has been or can be taken.''
Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as
otherwise provided, see section 4 of Pub. L. 108-155, set out as an
Effective Date note under section 355c of this title.
Effective Date of 1999 Amendment
Amendment by Pub. L. 106-113 effective 4 months after Nov. 29, 1999,
see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-113, set out
as a note under section 1 of Title 35, Patents.
Effective Date of 1997 Amendment
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997,
except as otherwise provided, see section 501 of Pub. L. 105-115, set
out as a note under section 321 of this title.
Effective Date of 1984 Amendment
Section 105 of Pub. L. 98-417 provided that:
``(a) The Secretary of Health and Human Services shall promulgate,
in accordance with the notice and comment requirements of section 553 of
title 5, United States Code, such regulations as may be necessary for
the administration of section 505 of the Federal Food, Drug, and
Cosmetic Act [this section], as amended by sections 101, 102, and 103 of
this Act, within one year of the date of enactment of this Act [Sept.
24, 1984].
``(b) During the period beginning sixty days after the date of the
enactment of this Act [Sept. 24, 1984], and ending on the date
regulations promulgated under subsection (a) take effect, abbreviated
new drug applications may be submitted in accordance with the provisions
of section 314.2 of title 21 of the Code of Federal Regulations and
shall be considered as suitable for any
drug which has been approved for safety and effectiveness under section
505(c) of the Federal Food, Drug, and Cosmetic Act [subsec. (c) of this
section] before the date of the enactment of this Act. If any such
provision is inconsistent with the requirements of section 505(j) of the
Federal Food, Drug, and Cosmetic Act, the Secretary shall consider the
application under the applicable requirements of such section. The
Secretary of Health and Human Services may not approve such an
abbreviated new drug application which is filed for a drug which is
described in sections 505(c)(3)(D) and 505(j)(4)(D) of the Federal Food,
Drug, and Cosmetic Act, except in accordance with such section.''
Effective Date of 1972 Amendment
Amendment by Pub. L. 92-387 effective on first day of sixth month
beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set out
as a note under section 360 of this title.
Effective Date of 1962 Amendment
Amendment by Pub. L. 87-781 effective on first day of seventh
calendar month following October 1962, see section 107 of Pub. L. 87-
781, set out as a note under section 321 of this title.
Construction of Amendments by Pub. L. 102-282
Amendment by Pub. L. 102-282 not to preclude any other civil,
criminal, or administrative remedy provided under Federal or State law,
including any private right of action against any person for the same
action subject to any action or civil penalty under an amendment made by
Pub. L. 102-282, see section 7 of Pub. L. 102-282, set out as a note
under section 335a of this title.
Transfer of Functions
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under section
321 of this title.
Effect of Amendment by Pub. L. 108-173 on Abbreviated New Drug
Applications
Pub. L. 108-173, title XI, Sec. 1103(b), Dec. 8, 2003, 117 Stat.
2461, provided that: ``The amendment made by subsection (a) [amending
this section] does not alter the standards for approval of drugs under
section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)).''
Federal Trade Commission Review
Pub. L. 108-173, title XI, subtitle B, Dec. 8, 2003, 117 Stat. 2461,
provided that:
``SEC. 1111. DEFINITIONS.
``In this subtitle:
``(1) ANDA.--The term `ANDA' means an abbreviated drug
application, as defined under section 201(aa) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 321(aa)].
``(2) Assistant attorney general.--The term `Assistant Attorney
General' means the Assistant Attorney General in charge of the
Antitrust Division of the Department of Justice.
``(3) Brand name drug.--The term `brand name drug' means a drug
for which an application is approved under section 505(c) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c)], including
an application referred to in section 505(b)(2) of such Act [21
U.S.C. 355(b)(2)].
``(4) Brand name drug company.--The term `brand name drug
company' means the party that holds the approved application
referred to in paragraph (3) for a brand name drug that is a listed
drug in an ANDA, or a party that is the owner of a patent for which
information is submitted for such drug under subsection (b) or (c)
of section 505 of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 355(b), (c)].
``(5) Commission.--The term `Commission' means the Federal Trade
Commission.
``(6) Generic drug.--The term `generic drug' means a drug for
which an application under section 505(j) of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 355(j)] is approved.
``(7) Generic drug applicant.--The term `generic drug applicant'
means a person who has filed or received approval for an ANDA under
section 505(j) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 355(j)].
``(8) Listed drug.--The term `listed drug' means a brand name
drug that is listed under section 505(j)(7) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 355(j)(7)].
``SEC. 1112. NOTIFICATION OF AGREEMENTS.
``(a) Agreement With Brand Name Drug Company.--
``(1) Requirement.--A generic drug applicant that has submitted
an ANDA containing a certification under section
505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 355(j)(2)(A)(vii)(IV)] and a brand name drug company that
enter into an agreement described in paragraph (2) shall each file
the agreement in accordance with subsection (c). The agreement shall
be filed prior to the date of the first commercial marketing of the
generic drug that is the subject of the ANDA.
``(2) Subject matter of agreement.--An agreement described in
this paragraph between a generic drug applicant and a brand name
drug company is an agreement regarding--
``(A) the manufacture, marketing or sale of the brand name
drug that is the listed drug in the ANDA involved;
``(B) the manufacture, marketing, or sale of the generic
drug for which the ANDA was submitted; or
``(C) the 180-day period referred to in section
505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 355(j)(5)(B)(iv)] as it applies to such ANDA or to any
other ANDA based on the same brand name drug.
``(b) Agreement With Another Generic Drug Applicant.--
``(1) Requirement.--A generic drug applicant that has submitted
an ANDA containing a certification under section
505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 355(j)(2)(A)(vii)(IV)] with respect to a listed drug and
another generic drug applicant that has submitted an ANDA containing
such a certification for the same listed drug shall each file the
agreement in accordance with subsection (c). The agreement shall be
filed prior to the date of the first commercial marketing of either
of the generic drugs for which such ANDAs were submitted.
``(2) Subject matter of agreement.--An agreement described in
this paragraph between two generic drug applicants is an agreement
regarding the 180-day period referred to in section 505(j)(5)(B)(iv)
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
355(j)(5)(B)(iv)] as it applies to the ANDAs with which the
agreement is concerned.
``(c) Filing.--
``(1) Agreement.--The parties that are required in subsection
(a) or (b) to file an agreement in accordance with this subsection
shall file with the Assistant Attorney General and the Commission
the text of any such agreement, except that such parties are not
required to file an agreement that solely concerns--
``(A) purchase orders for raw material supplies;
``(B) equipment and facility contracts;
``(C) employment or consulting contracts; or
``(D) packaging and labeling contracts.
``(2) Other agreements.--The parties that are required in
subsection (a) or (b) to file an agreement in accordance with this
subsection shall file with the Assistant Attorney General and the
Commission the text of any agreements between the parties that are
not described in such subsections and are contingent
upon, provide a contingent condition for, or are otherwise related
to an agreement that is required in subsection (a) or (b) to be
filed in accordance with this subsection.
``(3) Description.--In the event that any agreement required in
subsection (a) or (b) to be filed in accordance with this subsection
has not been reduced to text, each of the parties involved shall
file written descriptions of such agreement that are sufficient to
disclose all the terms and conditions of the agreement.
``SEC. 1113. FILING DEADLINES.
``Any filing required under section 1112 shall be filed with the
Assistant Attorney General and the Commission not later than 10 business
days after the date the agreements are executed.
``SEC. 1114. DISCLOSURE EXEMPTION.
``Any information or documentary material filed with the Assistant
Attorney General or the Commission pursuant to this subtitle shall be
exempt from disclosure under section 552 of title 5, United States Code,
and no such information or documentary material may be made public,
except as may be relevant to any administrative or judicial action or
proceeding. Nothing in this section is intended to prevent disclosure to
either body of the Congress or to any duly authorized committee or
subcommittee of the Congress.
``SEC. 1115. ENFORCEMENT.
``(a) Civil Penalty.--Any brand name drug company or generic drug
applicant which fails to comply with any provision of this subtitle
shall be liable for a civil penalty of not more than $11,000, for each
day during which such entity is in violation of this subtitle. Such
penalty may be recovered in a civil action brought by the United States,
or brought by the Commission in accordance with the procedures
established in section 16(a)(1) of the Federal Trade Commission Act (15
U.S.C. 56(a) [15 U.S.C. 56(a)(1)]).
``(b) Compliance and Equitable Relief.--If any brand name drug
company or generic drug applicant fails to comply with any provision of
this subtitle, the United States district court may order compliance,
and may grant such other equitable relief as the court in its discretion
determines necessary or appropriate, upon application of the Assistant
Attorney General or the Commission.
``SEC. 1116. RULEMAKING.
``The Commission, with the concurrence of the Assistant Attorney
General and by rule in accordance with section 553 of title 5, United
States Code, consistent with the purposes of this subtitle--
``(1) may define the terms used in this subtitle;
``(2) may exempt classes of persons or agreements from the
requirements of this subtitle; and
``(3) may prescribe such other rules as may be necessary and
appropriate to carry out the purposes of this subtitle.
``SEC. 1117. SAVINGS CLAUSE.
``Any action taken by the Assistant Attorney General or the
Commission, or any failure of the Assistant Attorney General or the
Commission to take action, under this subtitle shall not at any time bar
any proceeding or any action with respect to any agreement between a
brand name drug company and a generic drug applicant, or any agreement
between generic drug applicants, under any other provision of law, nor
shall any filing under this subtitle constitute or create a presumption
of any violation of any competition laws.
``SEC. 1118. EFFECTIVE DATE.
``This subtitle shall--
``(1) take effect 30 days after the date of the enactment of
this Act [Dec. 8, 2003]; and
``(2) shall apply to agreements described in section 1112 that
are entered into 30 days after the date of the enactment of this
Act.''
Report on Patient Access to New Therapeutic Agents for Pediatric Cancer
Pub. L. 107-109, Sec. 15(d), Jan. 4, 2002, 115 Stat. 1421, provided
that: ``Not later than January 31, 2003, the Secretary of Health and
Human Services, acting through the Commissioner of Food and Drugs and in
consultation with the Director of the National Institutes of Health,
shall submit to the Committee on Health, Education, Labor, and Pensions
of the Senate and the Committee on Energy and Commerce of the House of
Representatives a report on patient access to new therapeutic agents for
pediatric cancer, including access to single patient use of new
therapeutic agents.''
Data Requirements for Drugs and Biologics
Section 118 of Pub. L. 105-115 provided that: ``Within 12 months
after the date of enactment of this Act [Nov. 21, 1997], the Secretary
of Health and Human Services, acting through the Commissioner of Food
and Drugs, shall issue guidance that describes when abbreviated study
reports may be submitted, in lieu of full reports, with a new drug
application under section 505(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(b)) and with a biologics license application under
section 351 of the Public Health Service Act (42 U.S.C. 262) for certain
types of studies. Such guidance shall describe the kinds of studies for
which abbreviated reports are appropriate and the appropriate
abbreviated report formats.''
Requirements for Review of Approval Procedures and Current Good
Manufacturing Practices for Positron Emission Technology
Section 121(c) of Pub. L. 105-115 provided that:
``(1) Procedures and requirements.--
``(A) In general.--In order to take account of the special
characteristics of positron emission tomography drugs and the
special techniques and processes required to produce these drugs,
not later than 2 years after the date of enactment of this Act [Nov.
21, 1997], the Secretary of Health and Human Services shall
establish--
``(i) appropriate procedures for the approval of positron
emission tomography drugs pursuant to section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
``(ii) appropriate current good manufacturing practice
requirements for such drugs.
``(B) Considerations and consultation.--In establishing the
procedures and requirements required by subparagraph (A), the
Secretary of Health and Human Services shall take due account of any
relevant differences between not-for-profit institutions that
compound the drugs for their patients and commercial manufacturers
of the drugs. Prior to establishing the procedures and requirements,
the Secretary of Health and Human Services shall consult with
patient advocacy groups, professional associations, manufacturers,
and physicians and scientists licensed to make or use positron
emission tomography drugs.
``(2) Submission of new drug applications and abbreviated new drug
applications.--
``(A) In general.--Except as provided in subparagraph (B), the
Secretary of Health and Human Services shall not require the
submission of new drug applications or abbreviated new drug
applications under subsection (b) or (j) of section 505 (21 U.S.C.
355), for compounded positron emission tomography drugs that are not
adulterated drugs described in section 501(a)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) (as amended by
subsection (b)), for a period of 4 years after the date of enactment
of this Act [Nov. 21, 1997], or for 2 years after the date on which
the Secretary establishes procedures and requirements under
paragraph (1), whichever is longer.
``(B) Exception.--Nothing in this Act [see Short Title of 1997
Amendment note set out under section
301 of this title] shall prohibit the voluntary submission of such
applications or the review of such applications by the Secretary of
Health and Human Services. Nothing in this Act shall constitute an
exemption for a positron emission tomography drug from the
requirements of regulations issued under section 505(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)).''
``Compounded Positron Emission Topography Drug'' Defined
Section 121(e) of Pub. L. 105-115 provided that: ``As used in this
section [amending sections 321 and 351 of this title and enacting
provisions set out as notes under this section and section 351 of this
title], the term `compounded positron emission tomography drug' has the
meaning given the term in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321).''
Requirements for Radiopharmaceuticals
Section 122 of Pub. L. 105-115 provided that:
``(a) Requirements.--
``(1) Regulations.--
``(A) Proposed regulations.--Not later than 180 days after
the date of enactment of this Act [Nov. 21, 1997], the Secretary
of Health and Human Services, after consultation with patient
advocacy groups, associations, physicians licensed to use
radiopharmaceuticals, and the regulated industry, shall issue
proposed regulations governing the approval of
radiopharmaceuticals. The regulations shall provide that the
determination of the safety and effectiveness of such a
radiopharmaceutical under section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public
Health Service Act (42 U.S.C. 262) shall include consideration
of the proposed use of the radiopharmaceutical in the practice
of medicine, the pharmacological and toxicological activity of
the radiopharmaceutical (including any carrier or ligand
component of the radiopharmaceutical), and the estimated
absorbed radiation dose of the radiopharmaceutical.
``(B) Final regulations.--Not later than 18 months after the
date of enactment of this Act, the Secretary shall promulgate
final regulations governing the approval of the
radiopharmaceuticals.
``(2) Special rule.--In the case of a radiopharmaceutical, the
indications for which such radiopharmaceutical is approved for
marketing may, in appropriate cases, refer to manifestations of
disease (such as biochemical, physiological, anatomic, or
pathological processes) common to, or present in, one or more
disease states.
``(b) Definition.--In this section, the term `radiopharmaceutical'
means--
``(1) an article--
``(A) that is intended for use in the diagnosis or
monitoring of a disease or a manifestation of a disease in
humans; and
``(B) that exhibits spontaneous disintegration of unstable
nuclei with the emission of nuclear particles or photons; or
``(2) any nonradioactive reagent kit or nuclide generator that
is intended to be used in the preparation of any such article.''
Special Rule
Section 123(f) of Pub. L. 105-115 provided that: ``The Secretary of
Health and Human Services shall take measures to minimize differences in
the review and approval of products required to have approved biologics
license applications under section 351 of the Public Health Service Act
(42 U.S.C. 262) and products required to have approved new drug
applications under section 505(b)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)(1)).''
Transition
Section 125(d) of Pub. L. 105-115 provided that:
``(1) In general.--An application that was approved by the Secretary
of Health and Human Services before the date of the enactment of this
Act [Nov. 21, 1997] for the marketing of an antibiotic drug under
section 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357),
as in effect on the day before the date of the enactment of this Act,
shall, on and after such date of enactment, be considered to be an
application that was submitted and filed under section 505(b) of such
Act (21 U.S.C. 355(b)) and approved for safety and effectiveness under
section 505(c) of such Act (21 U.S.C. 355(c)), except that if such
application for marketing was in the form of an abbreviated application,
the application shall be considered to have been filed and approved
under section 505(j) of such Act (21 U.S.C. 355(j)).
``(2) Exception.--The following subsections of section 505 (21
U.S.C. 355) shall not apply to any application for marketing in which
the drug that is the subject of the application contains an antibiotic
drug and the antibiotic drug was the subject of any application for
marketing received by the Secretary of Health and Human Services under
section 507 of such Act (21 U.S.C. 357) before the date of the enactment
of this Act [Nov. 21, 1997]:
``(A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii),
(j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and
``(ii) The third and fourth sentences of subsection (b)(1)
(regarding the filing and publication of patent information); and
``(B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if
the investigations relied upon by the applicant for approval of the
application were not conducted by or for the applicant and for which
the applicant has not obtained a right of reference or use from the
person by or for whom the investigations were conducted.
``(3) Publication.--For purposes of this section, the Secretary is
authorized to make available to the public the established name of each
antibiotic drug that was the subject of any application for marketing
received by the Secretary for Health and Human Services under section
507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357) before
the date of enactment of this Act [Nov. 21, 1997].''
Termination of Advisory Panels
Advisory panels established after Jan. 5, 1973, to terminate not
later than the expiration of the 2-year period beginning on the date of
their establishment, unless, in the case of a panel established by the
President or an officer of the Federal Government, such panel is renewed
by appropriate action prior to the expiration of such 2-year period, or
in the case of a panel established by Congress, its duration is
otherwise provided for by law. See sections 3(2) and 14 of Pub. L. 92-
463, Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to Title
5, Government Organization and Employees.
Appeals Taken Prior to October 10, 1962
Section 104(d)(3) of Pub. L. 87-781 made amendments to subsec. (h)
of this section inapplicable to any appeal taken prior to Oct. 10, 1962.