FAST Generics Act of 2014

Summary

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.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 18 September 2014

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• Introduced in House (PDF)

  Introduced in House · EN · 18 September 2014

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• Introduced in House

  summary · EN · 18 September 2014

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