H.R. 2841 · 114th Congress
FAST Generics Act of 2015
Key: what the circles and colors mean
Each circle is a bill. The ring fills as it moves through Congress:
Under the number: the Yea · Nay count of its final (or latest) recorded vote. On a member's page, the small badge is how that member voted: Y Yea / Aye, N Nay / No, P Present, – Not voting.
Gold and violet are only for Yea and Nay; they never mean a party. A member's party is the letter on their photo.
Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
StiversSponsor9 cosponsors · 5 D, 4 R
R
McKinley
JR
R
Renacci
JS
D
Schakowsky
PT
R
Tiberi
PW
D
Welch
DD
D
DeGette
MC
D
Cartwright
JF
R
Fortenberry
MK
D
Kaptur5 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Fair Access for Safe and Timely Generics Act of 2015 or the FAST Generics Act of 2015
What it does: CRS summary · Introduced in House · Jun 18, 2015
Fair Access for Safe and Timely Generics Act of 2015 or the FAST Generics Act of 2015
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 the medication.
The FDA may waive the requirement that a drug use a single, shared system of elements to assure safe use with a comparable approved drug if the product developer is unable to finalize terms for a shared system with the license holder of the approved drug.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: FAST Generics Act of 2015
Also known as: Fair Access for Safe and Timely Generics Act of 2015
Latest action (Jun 19, 2015): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Jun 18, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.