844 -- Short on Competition Act | Poliscope

Short on Competition Act

844

116th Congress

Health

In Committee

Legislative Progress

✓

Introduced

Committee

Floor Vote

Other Chamber

Enacted

Introduced

March 14, 2019

Latest Action

March 14, 2019

Primary Sponsor

Amy KlobucharDemocratic(MN)

Momentum (last 30 days)

score

0 actions · 0 new cosponsors · 0 votes

Speed vs cohort

0pct

0d open

vs 5,086 other S bills in the 116th — cohort avg 30d

Summary

Short on Competition Act This bill requires the Food and Drug Administration (FDA) to provide temporary authorization to import certain prescription drugs facing shortages or in a marginally competitive drug market. Specifically, the FDA shall authorize importation of an eligible drug that is lifesaving, life-sustaining, or intended to treat or prevent a debilitating condition. To be eligible, a drug must (1) be facing a shortage, (2) require a prescription, (3) have received market authorization in certain foreign countries, and (4) have the same active ingredient as the drug for which there is a shortage in the United States. The drug's manufacturer must also seek FDA approval for the drug as a generic drug. The import authorization shall be for three years or until the shortage no longer applies, whichever occurs first. Importation shall begin within 60 days of the FDA receiving an application that meets all of the applicable requirements. The FDA may deny importation of a drug for reasons related to safety or effectiveness. Drugs in marginally competitive markets must be treated as being in a shortage for the purposes of this bill and for the purposes of expedited inspections and review. A drug is in a marginally competitive market if (1) there are fewer than five holders of approved applications for commercially available brand-name or generic versions of the drug, (2) the drug has been approved for at least 10 years, and (3) the patents on the drug's active ingredients have expired.

Lobbying filings that explicitly cite this bill (50)

These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.

Filing registrants (10)

TARPLIN, DOWNS & YOUNG, LLC (6)GOVERNMENT COUNSEL, LLC (4)AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP) (4)ASSOCIATION FOR ACCESSIBLE MEDICINES (1)BIOTECHNOLOGY INNOVATION ORGANIZATION (5)BRISTOL-MYERS SQUIBB COMPANY (11)GSK (FKA GLAXOSMITHKLINE INC.) (1)PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (1)PREMIER, INC. (11)TAKEDA PHARMACEUTICALS AMERICA INC (1)

Subjects (4)

Congressional oversight

Drug safety, medical device, and laboratory regulation

Prescription drugs

Trade restrictions

Actions (2)

March 14, 2019

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

March 14, 2019

Introduced in Senate

Committees

Committee	Chamber	Activity	Date
Health, Education, Labor, and Pensions Committee	Senate	Referred to	March 14, 2019

Text Versions

Version	Date	Links
Introduced in Senate	March 14, 2019	XML

Cosponsors (3)

Name	Party	State
Chuck Grassley	Republican	IA
Mike Lee	Republican	UT
Richard J. Durbin	Democratic	IL

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Sources: Congress.gov

Cited source text, amounts, lobbyists, and targets

Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)

Client expense: $540,000 · Firm income: Not reported

S. 844

DUANNE PEARSON SHARA SIEGEL SOUMI SAHA THOMAS RATLIFF mr BLAIR CHILDS

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PREMIER, INC.client→PREMIER, INC.

2020 · fourth_quarter · Health Issues