H.R. 2051 · 115th Congress
FAST Generics Act of 2017
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Never voted on. It didn't reach a floor vote before the 115th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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McKinleySponsor13 cosponsors · 9 D, 4 R
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Welch
DD
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DeGette
KS
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Schrader
SS
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Stivers
DL
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Lipinski
JF
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Fortenberry
JS
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Schakowsky
JR
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Renacci
MC
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Cartwright
RK
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Khanna
ML
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Lujan Grisham
DJ
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Joyce
AB
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Bera1 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 2017 or the FAST Generics Act of 2017
What it does: CRS summary · Introduced in House · Apr 6, 2017
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: FAST Generics Act of 2017
Also known as: Fair Access for Safe and Timely Generics Act of 2017
Latest action (Apr 7, 2017): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Apr 6, 2017
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.