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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (3)

Short Titles

Short Titles - House of Representatives

Short Titles as Introduced

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

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes.


Actions Overview (1)

Date
04/06/2017Introduced in House

All Actions (3)

Date
04/07/2017Referred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
04/06/2017Referred to the House Committee on Energy and Commerce.
Action By: House of Representatives
04/06/2017Introduced in House
Action By: House of Representatives

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
House Energy and Commerce04/06/2017 Referred to
House Energy and Commerce Subcommittee on Health04/07/2017 Referred to

No related bill information was received for H.R.2051.


Subjects (5)


Latest Summary (1)

There is one summary for H.R.2051. View summaries

Shown Here:
Introduced in House (04/06/2017)

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.