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H.R. 5657: Fair Access for Safe and Timely Generics Act of 2014

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H.R. 5657: Fair Access for Safe and Timely Generics Act of 2014

113th Congress · introduced 2014-09-18 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2014-09-18 · official record
  2. Who proposed it: Rep. Stivers, Steve [R-OH-15] · 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

Fair Access for Safe and Timely Generics Act of 2014

Plain summary

Fair Access for Safe and Timely Generics Act of 2014 or the FAST Generics Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug from restricting availability of the drug for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with any aspect of a risk evaluation and mitigation strategy (REMS). Directs the Secretary to authorize product developers to obtain approved drugs for testing if the product developer is a license holder of an approved drug or the Secretary determines the product developer can comply with laws applicable to drug development. Requires the Secretary to authorize a product developer to conduct human clinical trials with an approved drug if the product developer's clinical trial protocol includes protections comparable to the distribution restrictions on the approved drug. Establishes a process for a product developer to obtain reasonable quantities of an approved drug when those quantities are not available commercially. Allows the Secretary to prohibit or limit transfer of an approved drug to a product developer if the transfer poses an imminent hazard to public health. Eliminates license holder liability for claims arising from a product developer's testing of an approved drug. Requires the FDA and the Federal Trade Commission (FTC) to report on noncompliance with this Act. Allows the Secretary to waive the requirement that a drug use a single, shared system of elements to assure safe use with a comparable approved drug if the developer of the drug is unable to finalize terms for a shared system with the license holder of the approved drug.

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

Fair Access for Safe and Timely Generics Act of 2014

Source: Congressional Research Service summary (Introduced in House)

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The strongest published arguments

Arguments for (supporters)

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Arguments against (opponents)

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Alternatives

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

Officials and money

Sponsor: Rep. Stivers, Steve [R-OH-15] · 1 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Peter Welch (D-VT)

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)
Authorization
A law that creates or continues a government program and says what it may do, often with a suggested spending ceiling. An authorization alone does not provide money; a separate appropriation does.

Plain meanings written from linked sources. All words.

Sources

Record fed-us-cong113-hr5657 · catalog fed-us-congress-bills-cong113 · updated 2026-11-15 by psicol fed-bills-cong113