H.R.2841 - FAST Generics Act of 2015114th Congress (2015-2016)
|Sponsor:||Rep. Stivers, Steve [R-OH-15] (Introduced 06/18/2015)|
|Committees:||House - Energy and Commerce|
|Latest Action:||House - 06/19/2015 Referred to the Subcommittee on Health. (All Actions)|
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Summary: H.R.2841 — 114th Congress (2015-2016)All Information (Except Text)
Introduced in House (06/18/2015)
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.