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HR 5657 113th Congress House Health Administrative remedies Competition and antitrust Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Intellectual property Licensing and registrations Medical research Prescription drugs Product development and innovation Retail and wholesale trades

FAST Generics Act of 2014

Introduced: September 18, 2014 See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Sep 19, 2014
Referred to the Subcommittee on Health.
Sep 18, 2014
Referred to the House Committee on Energy and Commerce.
Sep 18, 2014
Introduced in House
 Plain-English summary Congressional Research Service

Fair Access for Safe and Timely Generics Act of 2014 or the FAST Generics Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug from restricting availability of the drug for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with any aspect of a risk evaluation and mitigation strategy (REMS).

Directs the Secretary to authorize product developers to obtain approved drugs for testing if the product developer is a license holder of an approved drug or the Secretary determines the product developer can comply with laws applicable to drug development.

Requires the Secretary to authorize a product developer to conduct human clinical trials with an approved drug if the product developer's clinical trial protocol includes protections comparable to the distribution restrictions on the approved drug.

Establishes a process for a product developer to obtain reasonable quantities of an approved drug when those quantities are not available commercially.

Allows the Secretary to prohibit or limit transfer of an approved drug to a product developer if the transfer poses an imminent hazard to public health.

Eliminates license holder liability for claims arising from a product developer's testing of an approved drug.

Requires the FDA and the Federal Trade Commission (FTC) to report on noncompliance with this Act.

Allows the Secretary to waive the requirement that a drug use a single, shared system of elements to assure safe use with a comparable approved drug if the developer of the drug is unable to finalize terms for a shared system with the license holder of the approved drug.

What's happening now September 19, 2014

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2