Issues affecting biotechnology firms engaged in developing gene therapies, including:
the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program;
Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices;
Changes to the Orphan Drug Act; and,
Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDA AAP-approved products under certain circumstances.)
Efforts to enact a so-called "reasonable pricing clause" in NIH licenses and CRADAs
Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics.
Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform.
Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products.
Efforts to impose "reasonable pricing clauses" on patent licenses from NIH-grantees to commercial partners.
The ongoing PTO-FDA collaboration on drug pricing.
Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Duration: September 3, 2018
to
December 31, 2023
General Issues: Health Issues , Trade (Domestic & Foreign) , Copyright/Patent/Trademark , Immigration , Taxation/Internal Revenue Code
Spending: about $1,705,000 (But it's complicated. Here's why.)
It can be tricky to figure out how much an organization spent on a particular lobbying engagement. The law only requires lobbyists to report the amount they were paid for federal lobbying each quarter rounded to the nearest $10,000—and if it's less than $3,000 in a given quarter (or less than $13,000 for organizations with in-house lobbyists), they don't have to disclose it at all. Plus, some organizations include spending that doesn’t belong in the report—for instance, money spent lobbying state governments or other legal work.
Agencies lobbied since 2018: U.S. Senate, House of Representatives, Patent & Trademark Office (PTO), Health & Human Services - Dept of (HHS), Food & Drug Administration (FDA), Centers For Medicare and Medicaid Services (CMS), Natl Institutes of Health (NIH), Justice - Dept of (DOJ), State - Dept of (DOS), Homeland Security - Dept of (DHS)
Lobbyists
Lobbyists named here were listed on a filing related to this lobbying engagement. They may not be working on it now. Occasionally, a single lobbyist whose name is spelled two different ways on filings may be represented twice here.
Lobbyist
Covered positions?
Bruce Artim
HHS detailee to U.S. Senate Judiciary Committee (1995-2006)(Staff Director/Chief Counsel 2003- 2004)
HHS/PHS/NIH Employee 1986 - 1995
Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)
Disclosures Filed
Once a lobbying engagement begins, the lobbyist or firm is required to file updates four times a year. Those updates sometimes change which lobbyists are involved or add new issues being discussed. When lobbyists stop working for a client, the firm is also supposed to file a report disclosing the end of the relationship.
4th Quarter, 2023
REGENXBIO in-house lobbying effort was terminated on Jan. 22
Original Filing: 301537679.xml
Lobbying Issues
Issues affecting biotechnology firms engaged in developing gene therapies, including:
the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program;
Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices;
Changes to the Orphan Drug Act; and,
Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDA AAP-approved products under certain circumstances.)
Efforts to enact a so-called "reasonable pricing clause" in NIH licenses and CRADAs
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS) Natl Institutes of Health (NIH)
Lobbying Issues
Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics.
Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform.
Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products.
Efforts to impose "reasonable pricing clauses" on patent licenses from NIH-grantees to commercial partners.
The ongoing PTO-FDA collaboration on drug pricing.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ) Food & Drug Administration (FDA) Natl Institutes of Health (NIH)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
Lobbying Issues
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Agencies Lobbied
U.S. House of Representatives U.S. Senate
Type of Issue
Taxation/Internal Revenue Code
3rd Quarter, 2023
In Q3, REGENXBIO had in-house lobbyists. The report was filed on Oct. 16, 2023.
Original Filing: 301501894.xml
Lobbying Issues
Issues affecting biotechnology firms engaged in developing gene therapies, including:
the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program;
Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices;
Changes to the Orphan Drug Act; and,
Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDA AAP-approved products under certain circumstances.)
Efforts to enact a so-called "reasonable pricing clause" in NIH licenses and CRADAs
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS) Natl Institutes of Health (NIH)
Lobbying Issues
Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics.
Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform.
Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products.
Efforts to impose "reasonable pricing clauses" on patent licenses from NIH-grantees to commercial partners.
The ongoing PTO-FDA collaboration on drug pricing.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ) Food & Drug Administration (FDA) Natl Institutes of Health (NIH)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
Lobbying Issues
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Agencies Lobbied
U.S. House of Representatives U.S. Senate
Type of Issue
Taxation/Internal Revenue Code
2nd Quarter, 2023
In Q2, REGENXBIO had in-house lobbyists. The report was filed on July 19, 2023.
Original Filing: 301483296.xml
Lobbying Issues
Issues affecting biotechnology firms engaged in developing gene therapies, including:
the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program;
Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices;
Changes to the Orphan Drug Act; and,
Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDAcAAP-approved products under certain circumstances.)
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics.
Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform.
Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products
The ongoing PTO-FDA collaboration on drug pricing
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ) Food & Drug Administration (FDA)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
Lobbying Issues
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
Agencies Lobbied
U.S. House of Representatives U.S. Senate
Type of Issue
Taxation/Internal Revenue Code
1st Quarter, 2023
In Q1, REGENXBIO had in-house lobbyists. The report was filed on April 19, 2023.
Original Filing: 301458522.xml
Lobbying Issues
Issues related to biotechnology firms engaged in developing gene therapies, including:
Successor legislation to the 117th Congress Guthrie-Schrader MVP Act (H.R. 7389) authorizing value based payments under the Medicaid program;
Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices;
Changes to the Orphan Drug Act; and,
Amendments to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics.
Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations.
Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products
The ongoing PTO-FDA collaboration on drug pricing
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ) Food & Drug Administration (FDA)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
Lobbying Issues
Proposals to allow the direct expensing on R&D expenditures, including the Hassan-Young bill, S.866, he American Innovation and Jobs Act.
Agencies Lobbied
U.S. House of Representatives U.S. Senate
Type of Issue
Taxation/Internal Revenue Code
4th Quarter, 2022
In Q4, REGENXBIO had in-house lobbyists. The report was filed on Jan. 18, 2023.
Original Filing: 301432100.xml
Lobbying Issues
Legislative proposals contained in year end Omnibus Appropriations Bill (H.R. 2617) including certain unenacted PDUFA "riders" such as clinical trial diversity and the FDA accelerated approval program.(H.R. 6696 and H.R. 6963.)
In addition, provisions in the omnibus bill related to the funding of newborn screening programs as well as the enactment of a National Academy of Medicine study of NBS.
Continued work on Value Based Agreement (VBA) legislation, H.R.7389, introduced by Reps. Schrader, Guthrie and Mullin on 4/4/22.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Proposed Covid-19 IP waivers under consideration by the U.S. Congress, Biden Administration, World Health Organization and World Trade Organization, including proposals to expand the waiver beyond vaccines to therapeutics and diagnostic products.
Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734.
IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions.
S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping)
S.1425/H.R. 2883 (citizen petitions)
S.1428/H.R.2891 (Rx patent settlements)
Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
Lobbying Issues
Legislative proposals to reinstate direct expensing of R&D investment such as considered but not included in the year end Omnibus Appropriations bill, H.R.2167.
Agencies Lobbied
U.S. House of Representatives U.S. Senate
Type of Issue
Taxation/Internal Revenue Code
3rd Quarter, 2022
In Q3, REGENXBIO had in-house lobbyists. The report was filed on Oct. 15, 2022.
Original Filing: 301404821.xml
Lobbying Issues
Legislative proposals to reauthorize the FDA Prescription Drug User Fee Act (PDUFA),S.4348 and H.R. 7667, including "rider"amendments such as those pertaining to the FDA accelerated approval pathway (H.R. 6696 and H.R. 6963.
Development of Value Based Agreement (VBA) legislation, H.R.7389, introduced by Reps. Schrader, Guthrie and Mullin on 4/4/22.
Newborn Screening Act reauthorization legislation: H.R. 482 and S.350.
Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill and in any revised versions of drug pricing legislation Congress is considering in 2022.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Proposed Covid-19 IP waivers under consideration by the U.S. Congress, Biden Administration, World Health Organization and World Trade Organization, including proposals to expand the waiver beyond vaccines to therapeutics and diagnostic products.
Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734.
IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code.
S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping)
S.1425/H.R. 2883 (citizen petitions)
S.1428/H.R.2891 (Rx patent settlements)
Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
Lobbying Issues
Legislative proposals to reinstate direct expensing of R&D investment such as included in the draft Senate version of the Build Back Better legislation and in some versions of the "U.S.- China" competitiveness legislation. Potential inclusion of the R&D expensing provision in any appropriation vehicles.
Agencies Lobbied
U.S. House of Representatives U.S. Senate
Type of Issue
Taxation/Internal Revenue Code
2nd Quarter, 2022
In Q2, REGENXBIO had in-house lobbyists. The report was filed on July 20, 2022.
Original Filing: 301392174.xml
Lobbying Issues
Legislative proposals to reauthorize the FDA Prescription Drug User Fee Act (PDUFA),S.4348 and H.R. 7667, including "rider"amendments such as those pertaining to the FDA accelerated approval pathway (H.R. 6696 and H.R. 6963.
Development of Value Based Agreement (VBA) legislation, H.R.7389, introduced by Reps. Schrader, Guthrie and Mullin on 4/4/22.
Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill and in any revised versions of drug pricing legislation Congress is considering in 2022.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Proposed Covid-19 IP waivers under consideration by the U.S. Congress, Biden Administration, World Health Organization and World Trade Organization.
Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Reform of Section 101 of the patent code.
IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code.
S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping)
S.1425/H.R. 2883 (citizen petitions)
S.1428/H.R.2891 (Rx patent settlements)
Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
Lobbying Issues
Legislative proposals to reinstate direct expensing of R&D investment such as included in the draft Senate version of the Build Back Better legislation and in some versions of the "U.S.- China" competitiveness legislation.
Agencies Lobbied
U.S. House of Representatives U.S. Senate
Type of Issue
Taxation/Internal Revenue Code
1st Quarter, 2022
In Q1, REGENXBIO had in-house lobbyists. The report was filed on April 20, 2022.
Original Filing: 301372235.xml
Lobbying Issues
Legislative proposals to reauthorize the FDA Prescription Drug User Fee Act (PDUFA) discussed at the February 3rd hearing of the House Energy & Commerce Committee.
Legislative discussed at the March 17th hearing of the House Energy & Commerce Committee as potential riders to the PDUFA bill, including:
H.R. 6696, the Accelerating Access for Patients Act;
H.R. 6963, the Accelerating Approval Integrity Act;
H.R. 6000, the CURES 2.0 Act;
H.R. 1730, the Speeding Therapy Access Today Act;
H.R. 6888, the Helping Experts Accelerate Rare Treatments Act;
Development of Value Based Agreement (VBA) legislation, including proposals under discussion by Rep. Schrader, Guthrie and Mullin.
Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill and in any revised versions of drug pricing legislation Congress is considering in 2022.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Proposed Covid-19 IP waivers under consideration by the U.S. Congress, Biden Administration, World Health Organization and World Trade Organization.
Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Reform of Section 101 of the patent code.
IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code.
S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping)
S.1425/H.R. 2883 (citizen petitions)
S.1428/H.R.2891 (Rx patent settlements)
Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
Lobbying Issues
Legislative proposals to reinstate direct expensing of R&D investment such as included in the draft Senate version of the Build Back Better legislation.
Type of Issue
Taxation/Internal Revenue Code
4th Quarter, 2021
In Q4, REGENXBIO had in-house lobbyists. The report was filed on Jan. 17, 2022.
Original Filing: 301324571.xml
Lobbying Issues
Development of Value Based Agreement (VBA) legislation.
Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill. Advocated in favor of a VBA amendment offered during the House E&C markup of the BBB bill. Participated in strategy sessions related to confirmation hearing for the Commissioner of Food and Drugs nominee.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Proposed Covid-19 IP waivers under consideration by the U.S. Congress, Biden Administration, World Health Organization and World Trade Organization.
Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Reform of Section 101 of the patent code.
IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code.
S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping)
S.1425/H.R. 2883 (citizen petitions)
S.1428/H.R.2891 (Rx patent settlements)
Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
3rd Quarter, 2021
REGENXBIO amended a lobbying report for in-house lobbying in Q32021 on Dec. 14, 2021
Original Filing: 301319086.xml
Lobbying Issues
Development of Value Based Agreement (VBA) legislation.
Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill
Health care provisions of the Covid-19 relief reconciliation bill, H.R. 1319, the American Rescue Plan Act of 2021.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Proposed Covid-19 IP waiver under consideration by the U.S. Congress, Biden Administration and World Trade Administration.
Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Reform of Section 101 of the patent code.
IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code.
S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping)
S.1425/H.R. 2883 (citizen petitions)
S.1428/H.R.2891 (Rx patent settlements)
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
3rd Quarter, 2021
In Q3, REGENXBIO had in-house lobbyists. The report was filed on Oct. 29, 2021.
Original Filing: 301316537.xml
Lobbying Issues
Development of Value Based Agreement (VBA) legislation.
Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill
Health care provisions of the Covid-19 relief reconciliation bill, H.R. 1319, the American Rescue Plan Act of 2021.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Proposed Covid-19 IP waiver under consideration by the U.S. Congress, Biden Administration and World Trade Administration.
Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Reform of Section 101 of the patent code.
IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code.
S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping)
S.1425/H.R. 2883 (citizen petitions)
S.1428/H.R.2891 (Rx patent settlements)
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
2nd Quarter, 2021
In Q2, REGENXBIO had in-house lobbyists. The report was filed on July 20, 2021.
Original Filing: 301289674.xml
Lobbying Issues
Development of Value Based Agreement (VBA) legislation.
Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.)
Health care provisions of the Covid-19 relief reconciliation bill, H.R. 1319, the American Rescue Plan Act of 2021.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Proposed Covid-19 IP waiver under consideration by the U.S. Congress, Biden Administration and World Trade Administration.
Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Reform of Section 101 of the patent code.
IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
1st Quarter, 2021
In Q1, REGENXBIO had in-house lobbyists. The report was filed on April 21, 2021.
Original Filing: 301268653.xml
Lobbying Issues
Development of Value Based Agreement (VBA) legislation.
Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.)
Health care provisions of the Covid-19 relief reconciliation bill, H.R. 1319, the American Rescue Plan Act of 2021.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Proposed Covid-19 IP waiver under consideration by the U.S. Congress, Biden Administration and World Trade Administration.
Retention of 12 years of regulatory data protection for biologics in international trade agreements.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Reform of Section 101 of the patent code.
IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
4th Quarter, 2020
In Q4, REGENXBIO had in-house lobbyists. The report was filed on Jan. 21, 2021.
Original Filing: 301242895.xml
Lobbying Issues
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules. With respect to the pandemic relief legislation, lobbied on issues related to certain proposals potentially affecting the reimbursement of gene therapies by the Medicare and Medicaid programs. This includes responding to the CMS regulatory proposal with respect to value based agreements and providing feedback on how this proposed rule affects legislation on VBAs pending in the Senate and being planned in the House. Activities included responding to Interim Final Rule known as the "Most Favored Nation" reimbursement system for certain Part B drugs.
Met with HHS Deputy Assistant Secretary for Legislation (Health) on matters pertaining to newborn screening legislation and the operation of the newborn screening advisory committee. In addition, working to achieve the reauthorization of the soon-expiring Pediatric Priority Review Voucher legislation.
Identify issues and allies with respect to the upcoming FDA User Fee reauthorization legislation (PDUFA VII) and the under development CURES 2.0 legislative initiative. Identified issues relevant to possible participation in NIH-FDA-FNIH Bespoke Gene Therapy Consortium.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement. Planned trade related activities for new Administration and 117th Congress.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy.
Met with the Assistant Attorney General for the Antitrust Division and other Antitrust Division officials with representatives of the Section 101 cross-coalition on patent reform issues. Followed up with the AAG for Antitrust and Antitrust Division staff on issues related to the anti-competitive effects of current U.S. case law and PTO administrative actions related to subject matter patentability.
Assisted Senior Vice President and Chief Patent Counsel in her participation on joint DOJ(ATR)-PTO Workshop on Competition Issues in the Life Sciences. Participated in meetings of the Section 101 Workgroup and Senate staff in preparation for discussion of legislative response to certain patent issues related to Section 101.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries.
Analyzed and planned response to an Executive Order restricting immigration of highly-qualified non-U.S. citizen scientists and clinical trial patients.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
3rd Quarter, 2020
In Q3, REGENXBIO had in-house lobbyists. The report was filed on Oct. 20, 2020.
Original Filing: 301217188.xml
Lobbying Issues
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules. With respect to the pandemic relief legislation, lobbied on issues related to certain proposals potentially affecting the reimbursement of gene therapies by the Medicare and Medicaid programs. This includes responding to the CMS regulatory proposal with respect to value based agreements and providing feedback on how this proposed rule affects legislation on VBAs pending in the Senate and being planned in the House.
Met with HHS Deputy Assistant Secretary for Legislation (Health) on matters pertaining to newborn screening legislation and the operation of the newborn screening advisory committee. In addition, working to achieve the reauthorization of the soon-expiring Pediatric Priority Review Voucher legislation.
Identify issues and allies with respect to the upcoming FDA User Fee reauthorization legislation (PDUFA VII) and the under development CURES 2.0 legislative initiative. Identified issues relevant to possible participation in NIH-FDA-FNIH Bespoke Gene Therapy Consortium.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy.
Met with the Assistant Attorney General for the Antitrust Division and other Antitrust Division officials with representatives of the Section 101 cross-coalition on patent reform issues. Followed up with the AAG for Antitrust and Antitrust Division staff on issues related to the anti-competitive effects of current U.S. case law and PTO administrative actions related to subject matter patentability.
Assisted Senior Vice President and Chief Patent Counsel in her participation on joint DOJ(ATR)-PTO Workshop on Competition Issues in the Life Sciences
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries.
Analyzed and planned response to an Executive Order restricting immigration of highly-qualified non-U.S. citizen scientists and clinical trial patients.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
2nd Quarter, 2020
In Q2, REGENXBIO had in-house lobbyists. The report was filed on July 20, 2020.
Original Filing: 301201957.xml
Lobbying Issues
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules. With respect to the pandemic relief legislation, lobbied on issued related to certain proposals potentially affecting the reimbursement of gene therapies by the Medicare and Medicaid programs. This includes responding to the CMS regulatory proposal with respect to value based agreements and providing feedback on how this proposed rule affects legislation on VBAs pending in the Senate and being planned in the House.
Met with HHS Deputy Assistant Secretary for Legislation (Health) on matters pertaining to newborn screening legislation and the operation of the newborn screening advisory committee. In addition, working to achieve the reauthorization of the soon-expiring Pediatric Priority Review Voucher legislation.
Identify issues and allies with respect to the upcoming FDA User Fee reauthorization legislation (PDUFA VII) and the under development CURES 2.0 legislative initiative.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy.
Met with the Assistant Attorney General for the Antitrust Division and other Antitrust Division officials with representatives of the Section 101 cross-coalition on patent reform issues. Followed up with the AAG for Antitrust and Antitrust Division staff on issues related to the anti-competitive effects of current U.S. case law and PTO administrative actions related to subject matter patentability.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries.
Analyzed and planned response to an Executive Order restricting immigration of highly-qualified non-U.S. citizen scientists and clinical trial patients.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
1st Quarter, 2020
In Q1, REGENXBIO had in-house lobbyists. The report was filed on April 20, 2020.
Original Filing: 301173297.xml
Lobbying Issues
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules. With respect to the pandemic relief legislation, lobbied on issued related to certain proposals potentially affecting the reimbursement of gene therapies by the Medicare and Medicaid programs.
Met with HHS Deputy Assistant Secretary for Legislation (Health) on matters pertaining to newborn screening legislation and the operation of the newborn screening advisory committee.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy.
Met with the Assistant Attorney General for the Antitrust Division and other Antitrust Division officials with representatives of the Section 101 cross-coalition on patent reform issues.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Justice - Dept of (DOJ)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
4th Quarter, 2019
In Q4, REGENXBIO had in-house lobbyists. The report was filed on Jan. 31, 2020.
Original Filing: 301131052.xml
Lobbying Issues
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
3rd Quarter, 2019
In Q3, REGENXBIO had in-house lobbyists. The report was filed on Oct. 21, 2019.
Original Filing: 301077124.xml
Lobbying Issues
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Copyright/Patent/Trademark
Lobbying Issues
Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries.
Agencies Lobbied
U.S. Senate U.S. House of Representatives State - Dept of (DOS) Homeland Security - Dept of (DHS)
2nd Quarter, 2019
In Q2, REGENXBIO had in-house lobbyists. The report was filed on Aug. 6, 2019.
Original Filing: 301060701.xml
Lobbying Issues
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS) Food & Drug Administration (FDA) Centers For Medicare and Medicaid Services (CMS)
Lobbying Issues
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Copyright/Patent/Trademark
1st Quarter, 2019
In Q1, REGENXBIO had in-house lobbyists. The report was filed on April 19, 2019.
Original Filing: 301031670.xml
Lobbying Issues
Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO) Health & Human Services - Dept of (HHS)
Lobbying Issues
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Trade (Domestic & Foreign)
Lobbying Issues
Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights.
Agencies Lobbied
U.S. Senate U.S. House of Representatives Patent & Trademark Office (PTO)
Type of Issue
Copyright/Patent/Trademark
4th Quarter, 2018
In Q4, REGENXBIO did no lobbying for itself. The report was filed on March 25, 2019.
Original Filing: 301021829.xml
3rd Quarter, 2018
In Q3, REGENXBIO did no lobbying for itself. The report was filed on March 25, 2019.
Original Filing: 301021828.xml
Source: Clerk of the U.S. House of Representatives and Secretary of the Senate