US Congress House Bill 2841 (Prior Session Legislation)

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Spectrum: Bipartisan Bill
Status: Introduced on June 18 2015 - 25% progression, died in committee
Action: 2015-06-19 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

FAST Generics Act of 2015 Fair Access for Safe and Timely 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.

FAST Generics Act of 2015 Fair Access for Safe and Timely Generics Act of 2015

Rep. Steve Stivers [R-OH]	Sen. Peter Welch [D-VT]	Rep. David McKinley [R-WV]	Rep. Janice Schakowsky [D-IL]
Rep. James Renacci [R-OH]	Rep. Patrick Tiberi [R-OH]	Rep. Diana DeGette [D-CO]	Rep. Jeff Fortenberry [R-NE]
Rep. Matthew Cartwright [D-PA]	Rep. Marcy Kaptur [D-OH]

Date	Chamber	Action
2015-06-19	House	Referred to the Subcommittee on Health.
2015-06-18	House	Referred to the House Committee on Energy and Commerce.
2015-06-18	House	Introduced in House

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/house-bill/2841/all-info
Text	https://www.congress.gov/114/bills/hr2841/BILLS-114hr2841ih.pdf