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Lobbying Relationship

Client

Shire Pharmaceuticals LLC

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Lobbying firm

Shire Pharmaceuticals LLC

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  • -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -Expanded Access -Rare Disease awareness -Newborn Screening
  • - Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - HR 4724: Medicare IVIG Access Enhancement Act - Medicare Part D
  • HR 2587/S1194: Medical Nutrition Equity Act of 2017 HR6: Support for Patients and Communities Act 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing
  • Orphan drug tax credit
  • Committee on Foreign Investment in the United States (CFIUS) reform
  • HR 5340/S1390: Stronger Patents Act

Duration: to

General Issues: Pharmacy, Medicare/Medicaid, Health Issues, Taxation/Internal Revenue Code, Trade (Domestic & Foreign), Copyright/Patent/Trademark, Foreign Relations, Medical/Disease Research/Clinical Labs

Spending: about $11,661,000 (But it's complicated. Here's why.)

Agencies lobbied since 2007: House of Representatives, U.S. Senate, Congressional Budget Office (CBO), Drug Enforcement Administration (DEA), Centers For Medicare and Medicaid Services (CMS), Office of Management & Budget (OMB), Food & Drug Administration (FDA), Centers For Medicare and Medicaid Services (CMS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), Health & Human Services - Dept of (HHS), Government Accountability Office (GAO), U.S. Senate,, Veterans Affairs - Dept of (VA), Food & Drug Administration (FDA),, Natl Economic Council (NEC), Executive Office of the President (EOP), Natl Institutes of Health (NIH),, House of Representatives,

Related Foreign Entities: Shire Pharmaceuticals (Basingstoke, GBR); contribution to lobbying: $0; ownership 100%

Bills mentioned

H.R.1628: American Health Care Act of 2017

Sponsor: Diane Black (R-Tenn.)

H.R.2430: FDA Reauthorization Act of 2017

Sponsor: Greg Walden (R-Ore.)

S.934: FDA Reauthorization Act of 2017

Sponsor: Lamar Alexander (R-Tenn.)

S.456: RACE for Children Act

Sponsor: Michael Bennet (D-Colo.)

H.R.1231: RACE for Children Act

Sponsor: Michael McCaul (R-Texas)

S.204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina...

Sponsor: Ron Johnson (R-Wis.)

H.R.878: Right to Try Act of 2017

Sponsor: Andy Biggs (R-Ariz.)

H.R.2368: Right to Try Act

Sponsor: Brian Fitzpatrick (R-Pa.)

H.R.2026: Pharmaceutical Information Exchange Act

Sponsor: Brett Guthrie (R-Ky.)

H.R.2376: Drug Diversion and Counterfeit Crackdown Act of 2017

Sponsor: Leonard Lance (R-N.J.)

H.R.1703: Medical Product Communications Act of 2017

Sponsor: Morgan Griffith (R-Va.)

H.R.3172: Medicare IVIG Demonstration Extension Act of 2017

Sponsor: Kevin Brady (R-Texas)

S.524: Comprehensive Addiction and Recovery Act of 2016

Sponsor: Sheldon Whitehouse (D-R.I.)

H.R.953: Comprehensive Addiction and Recovery Act of 2015

Sponsor: F. James Sensenbrenner (R-Wis.)

H.R.6: 21st Century Cures Act

Sponsor: Fred Upton (R-Mich.)

H.R.909: Andrea Sloan CURE Act

Sponsor: Michael McCaul (R-Texas)

S.2912: Trickett Wendler Right to Try Act of 2016

Sponsor: Ron Johnson (R-Wis.)

S.1878: Advancing Hope Act of 2016

Sponsor: Bob Casey (D-Pa.)

H.R.1537: Advancing Hope Act of 2015

Sponsor: G. K. Butterfield (D-N.C.)

H.R.971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Sponsor: Gus Bilirakis (R-Fla.)

S.1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Sponsor: Orrin G. Hatch (R-Utah)

S.275: Medicare Home Infusion Site of Care Act of 2015

Sponsor: Johnny Isakson (R-Ga.)

H.R.605: Medicare Home Infusion Site of Care Act of 2015

Sponsor: Eliot L. Engel (D-N.Y.)

S.2689: REGROW Act

Sponsor: Mark Steven Kirk (R-Ill.)

H.R.2515: Anna Westin Act of 2015

Sponsor: Ted Deutch (D-Fla.)

S.1865: Anna Westin Act of 2015

Sponsor: Amy Klobuchar (D-Minn.)

H.R.9: Innovation Act

Sponsor: Robert W. Goodlatte (R-Va.)

S.632: STRONG Patents Act of 2015

Sponsor: Christopher A. Coons (D-Del.)

S.2041: Promoting Life-Saving New Therapies for Neonates Act of 2015

Sponsor: Bob Casey (D-Pa.)

S.481: Improving Regulatory Transparency for New Medical Therapies Act

Sponsor: Orrin G. Hatch (R-Utah)

S.1767: Combination Product Regulatory Fairness Act of 2016

Sponsor: Johnny Isakson (R-Ga.)

H.R.3742: Access to Marketplace Insurance Act

Sponsor: Kevin Cramer (R-N.D.)

H.R.5805: Andrea Sloan CURE Act

Sponsor: Michael McCaul (R-Texas)

H.R.1281: Newborn Screening Saves Lives Reauthorization Act of 2014

Sponsor: Lucille Roybal-Allard (D-Calif.)

H.J.RES.59: Continuing Appropriations Resolution, 2014

Sponsor: Harold Rogers (R-Ky.)

H.R.2672: Preserving Access to Orphan Drugs Act of 2011

Sponsor: Jim Gerlach (R-Pa.)

S.1423: Preserving Access to Orphan Drugs Act of 2011

Sponsor: Patrick J. Toomey (R-Pa.)

H.R.8: American Taxpayer Relief Act of 2012

Sponsor: Dave Camp (R-Mich.)

S.481: Federal Response to Eliminate Eating Disorders Act

Sponsor: Tom Harkin (D-Iowa)

H.R.2245: Preserving Access to Life-Saving Medications Act of 2011

Sponsor: Diana DeGette (D-Colo.)

H.R.3839: Drug Shortage Prevention Act of 2012

Sponsor: John Carney (D-Del.)

H.R.5651: Food and Drug Administration Reform Act of 2012

Sponsor: Fred Upton (R-Mich.)

S.296: Preserving Access to Life-Saving Medications Act

Sponsor: Amy Klobuchar (D-Minn.)

S.3187: Food and Drug Administration Safety and Innovation Act

Sponsor: Tom Harkin (D-Iowa)

H.R.3737: ULTRA

Sponsor: Cliff Stearns (R-Fla.)

H.R.4132: FAST Act

Sponsor: Cliff Stearns (R-Fla.)

S.606: Creating Hope Act of 2011

Sponsor: Bob Casey (D-Pa.)

S.2113: TREAT Act

Sponsor: Kay Hagan (D-N.C.)

H.R.3590: Patient Protection and Affordable Care Act

Sponsor: Charles B. Rangel (D-N.Y.)

H.R.4872: Health Care and Education Reconciliation Act of 2010

Sponsor: John M. Spratt Jr. (D-S.C.)

H.R.1548: Pathway for Biosimilars Act

Sponsor: Anna G. Eshoo (D-Calif.)

H.R.1427: Promoting Innovation and Access to Life-Saving Medicine Act

Sponsor: Henry A. Waxman (D-Calif.)

H.R.3200: America's Affordable Health Choices Act of 2009

Sponsor: John D. Dingell (D-Mich.)

H.R.5629: Pathway for Biosimilars Act

Sponsor: Anna G. Eshoo (D-Calif.)

H.R.1: An Act to provide for reconciliation pursuant to titles II and V of the...

Sponsor: Kevin Brady (R-Texas)

H.R.1892: Bipartisan Budget Act of 2018

Sponsor: John B. Larson (D-Conn.)

H.R.6: SUPPORT for Patients and Communities Act

Sponsor: Greg Walden (R-Ore.)

H.R.4724: Medicare IVIG Access Enhancement Act

Sponsor: George Holding (R-N.C.)

H.R.2587: Medical Nutrition Equity Act of 2017

Sponsor: John Delaney (D-Md.)

S.1194: Medical Nutrition Equity Act of 2017

Sponsor: Bob Casey (D-Pa.)

H.R.5340: STRONGER Patents Act of 2018

Sponsor: Steve Stivers (R-Ohio)

S.1390: STRONGER Patents Act of 2017

Sponsor: Christopher A. Coons (D-Del.)

H.R.4170: Disclosing Foreign Influence Act

Sponsor: Mike Johnson (R-La.)

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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?
Joff Masukawa Senior Director, Govt. Relations and Public Policy
Mark Lenker Staff, Sen. Committee on Government Affairs Senior Legis. Asst., Rep.Curt Weldon
John Greissing Legal Fellow, Counsel, S. Committee on Judiciary
Jed Perry n/a
Engel Burns n/a
Edward Buckley n/a
Engle Burns n/a
Carrie Burke n/a
Julie Letwat n/a
Theresa Dixon n/a
Margaret Mann n/a

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.

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Registration

Source: Clerk of the U.S. House of Representatives and Secretary of the Senate

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