US Congress House Bill 2051 (Prior Session Legislation)

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Spectrum: Slight Partisan Bill (Democrat 9-5)
Status: Introduced on April 6 2017 - 25% progression, died in committee
Action: 2017-04-07 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

FAST Generics Act of 2017 Fair Access for Safe and Timely 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.

FAST Generics Act of 2017 Fair Access for Safe and Timely Generics Act of 2017

Rep. David McKinley [R-WV]	Sen. Peter Welch [D-VT]	Rep. Steve Stivers [R-OH]	Rep. Kurt Schrader [D-OR]
Rep. Diana DeGette [D-CO]	Rep. Daniel Lipinski [D-IL]	Rep. Janice Schakowsky [D-IL]	Rep. Jeff Fortenberry [R-NE]
Rep. James Renacci [R-OH]	Rep. Matthew Cartwright [D-PA]	Rep. Ro Khanna [D-CA]	Rep. Michelle Lujan Grisham [D-NM]
Rep. David Joyce [R-OH]	Rep. Ami Bera [D-CA]

Date	Chamber	Action
2017-04-07	House	Referred to the Subcommittee on Health.
2017-04-06	House	Referred to the House Committee on Energy and Commerce.
2017-04-06	House	Introduced in House

Type	Source
Summary	https://www.congress.gov/bill/115th-congress/house-bill/2051/all-info
Text	https://www.congress.gov/115/bills/hr2051/BILLS-115hr2051ih.pdf