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H.R.4132 - FAST Act

To amend section 506 of the Federal Food, Drug, and Cosmetic Act to expedited approval of drugs for serious or life-threatening diseases or conditions. view all titles (3)

All Bill Titles

  • Official: To amend section 506 of the Federal Food, Drug, and Cosmetic Act to expedited approval of drugs for serious or life-threatening diseases or conditions. as introduced.
  • Short: FAST Act as introduced.
  • Short: Faster Access to Specialized Treatments Act as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
03/05/12
 
 
 
 
 
 
 

Sponsor

S000822

Representative

Clifford Stearns

R-FL

View Co-Sponsors (21)

Official Summary

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-thre

Official Summary

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. 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.

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Organizations Supporting H.R.4132

  • Alnylam Pharmaceuticals
  • National Brain Tumor Society
  • Biotechnology Industry Organization
  • National Venture Capital Association
  • Parkinson's Action Network
  • Lymphangiomatosis and Gorham’s Disease Alliance
  • ...and 4 more. See all.

Organizations Opposing H.R.4132

  • None via MapLight at this time.


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