H.R. 749 · 115th Congress
Lower Drug Costs through Competition Act
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Never voted on. It didn't reach a floor vote before the 115th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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SchraderSponsor24 cosponsors · 16 D, 8 R
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Bilirakis
AB
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Bera
JC
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Cooper
JC
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Costa
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Lipinski
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Moulton
BP
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Posey
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Peters
KS
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Sinema
CP
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Peterson
TO
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O’Halleran
BG
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Guthrie
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Bishop
HC
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Cuellar
DS
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Soto
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Walz
CC
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Crist
BS
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Schneider
DB
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Bacon
JF
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Fortenberry
JG
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González-Colón
JG
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Gottheimer
GG
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Gianforte
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Knight9 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not…
What it does: CRS summary · Introduced in House · Jan 30, 2017
Lower Drug Costs through Competition Act
This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications.
The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 180 days. The FDA may expedite the inspection of a facility proposed to manufacture such a drug.
Beginning FY2019, the FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application once the drug has a sustained market presence. A voucher may be used to have the FDA review and take action upon a generic drug application within 180 days of submission. The FDA must establish an additional user fee for applications subject to a voucher. This voucher program is terminated at the start of FY2024.
The FDA must periodically report on generic drug applications filed before FY2018 that are still pending.
For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations.
The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Lower Drug Costs through Competition Act
Latest action (Feb 3, 2017): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Jan 30, 2017
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.