United States 115th Congress Status: In Committee 1 R cosponsors

HR 2051 — FAST Generics Act of 2017

Last action — Referred to the Subcommittee on Health.

  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed House
  4. 4
    Passed Senate
  5. 5
    To Executive
  6. 6
    Enacted

This bill died with 115th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there are no live odds of enactment. It would have to be reintroduced in the current session to move again.

In plain language

The bill aims to ensure competitive access to drugs and biological products for developers.

This legislation seeks to amend the Federal Food, Drug, and Cosmetic Act to facilitate access for eligible product developers to approved drugs and biological products. The goal is to support the development of new and generic drugs and biosimilars by preventing competitive access restrictions.

What this means for you
  • Workers: The bill may facilitate job creation in the pharmaceutical development sector by encouraging more product innovation.
  • Consumers: Consumers could benefit from increased availability of affordable generic drugs and biosimilars.

Summary

Fair Access for Safe and Timely Generics Act of 2017 or the FAST Generics Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS). Upon request, the license holder of a medication that is not subject to a REMS must provide a product developer with the medication for testing. For a medication subject to a REMS, a product developer must have FDA authorization to obtain the medication before the license holder must provide it. The FDA may authorize a product developer to conduct testing and clinical trials with the medication. A wholesaler or specialty distributor who receives a request from a product developer for a medication for testing may not disclose to the license holder the identity of the product developer. The FDA may prohibit or limit transfer of a medication to a product developer if the transfer poses an imminent hazard to public health. License holders are not liable for claims arising from a product developer testing a medication. The FDA may waive the requirement that a medication use a single, shared system of elements to assure safe use with a comparable approved medication if the product developer is unable to finalize terms for a shared system with the license holder of the approved medication.

Bill Text

Action History

  1. Introduced in House

  2. Introduced in House

  3. Referred to the House Committee on Energy and Commerce.

  4. Referred to the Subcommittee on Health.

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

healthcare health-insurance
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Frequently asked questions

What does HR 2051 do?
Fair Access for Safe and Timely Generics Act of 2017 or the FAST Generics Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS). Upon request, the license holder of a medication that is not subject to a REMS must provide a product developer with the medication for testing. For a medication subject to a REMS, a product developer must have FDA authorization to obtain the medication before the license holder must provide it. The FDA may authorize a product developer to conduct testing and clinical trials with the medication. A wholesaler or specialty distributor who receives a request from a product developer for a medication for testing may not disclose to the license holder the identity of the product developer. The FDA may prohibit or limit transfer of a medication to a product developer if the transfer poses an imminent hazard to public health. License holders are not liable for claims arising from a product developer testing a medication. The FDA may waive the requirement that a medication use a single, shared system of elements to assure safe use with a comparable approved medication if the product developer is unable to finalize terms for a shared system with the license holder of the approved medication.
Who sponsors HR 2051?
HR 2051 is sponsored by McKinley, David B. (Republican).
What is the current status of HR 2051?
This bill died with 115th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 2051?
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