HR 2051 · 115th Congress · Health

FAST Generics Act of 2017

Introduced 2017-04-06· Sponsored by Rep. McKinley, David B. [R-WV-1]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Health.(2017-04-07)

Plain Language Summary

[AI summary unavailable — showing source text] 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…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (13)

9 Democrats4 Republicans