HR 5657 · 113th Congress · Health

FAST Generics Act of 2014

Introduced 2014-09-18· Sponsored by Rep. Stivers, Steve [R-OH-15]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Health.(2014-09-19)

Plain Language Summary

[AI summary unavailable — showing source text] 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 t…

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

Cosponsors (1)

1 Democrat