PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in House · Mar 5, 2012
Faster Access to Specialized Treatments Act or FAST Act - Expresses the sense of Congress that the Food and Drug Administration (FDA) should apply specified accelerated approval and the fast track provisions to expedite the development and availability of treatments for serious or life-threatening diseases or conditions while maintaining appropriate safety and effectiveness standards.
Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a new drug, to include as a fast track product a new drug, either alone or in combination with one or more other drugs, that is intended for the treatment of a serious or life-threatening disease or condition.
Permits the Secretary to approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, upon a determination that the product has an effect on: (1) a surrogate endpoint that is reasonably likely to predict clinical benefit; or (2) on a clinical endpoint, including an endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.
Showing the opening paragraphs of the official summary.
Directs the Secretary, in conjunction with other planned reviews of the new drug review process, to contract with an independent entity with expertise in assessing biopharmaceutical development and regulatory review programs to evaluate the FDA's application of the fast track processes on the development and availability of innovative treatments for patients suffering from serious or life-threatening conditions.
People & committees
Rep. Stearns, Cliff [R-FL-6] · R–FL
Legislative record
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Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Aug 14, 2025. Consult Congress.gov for the current record.
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