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H.R. 4784: Lower Drug Costs through Competition Act

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H.R. 4784: Lower Drug Costs through Competition Act

114th Congress · introduced 2016-03-17 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2016-03-17 · official record
  2. Who proposed it: Rep. Schrader, Kurt [D-OR-5] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
  5. If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Lower Drug Costs through Competition Act

Plain summary

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 FY2018, 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 end of FY2021. The FDA must periodically report on generic drug applications filed before FY2017 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.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Lower Drug Costs through Competition Act

Source: Congressional Research Service summary (Introduced in House)

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The strongest published arguments

Arguments for (supporters)

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Schrader, Kurt [D-OR-5] · 16 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Gus M. Bilirakis (R-FL), Scott H. Peters (D-CA), Seth Moulton (D-MA), James A. Himes (D-CT), Jim Costa (D-CA), Ami Bera (D-CA)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)
Bill
A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).

Plain meanings written from linked sources. All words.

Sources

Record fed-us-cong114-hr4784 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114