S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012

A bill to provide for the expedited development and evaluation of drugs designated as breakthrough drugs. view all titles (2)

All Bill Titles

  • Official: A bill to provide for the expedited development and evaluation of drugs designated as breakthrough drugs. as introduced.
  • Short: Advancing Breakthrough Therapies for Patients Act of 2012 as introduced.

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Introduced
 
Senate
Passes
 
House
Passes
 
President
Signs
 

 
03/25/12
 
 
 
 
 
 
 

Official Summary

3/26/2012--Introduced.Advancing Breakthrough Therapies for Patients Act of 2012 - 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 drug, to expedite the drug's development and review if: (1)

Official Summary

3/26/2012--Introduced.Advancing Breakthrough Therapies for Patients Act of 2012 - 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 drug, to expedite the drug's development and review if:
(1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and
(2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Authorizes the drug's sponsor to request the Secretary to designate the drug as a breakthrough therapy. Requires the Secretary, within 60 days of such request, to determine whether the drug meets such criteria and, if so, make such designation, followed by appropriate actions to expedite its development and review for approval. Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations. Requires the Secretary to contract with an independent entity to evaluate the manner by which the Food and Drug Administration (FDA) has applied the processes for the breakthrough therapy determination, and the impact of such processes on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions. Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved.

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Organizations Supporting S.2236

  • Onyx Pharmaceuticals
  • Treat ALS Now
  • Accelerate Brain Cancer Cure
  • Accelerate Cure/Treatments for Alzheimers Disease
  • Adenoid Cystic Carcinoma Research Foundation
  • AHAF Alzheimer's Disease Research
  • ...and 40 more. See all.

Organizations Opposing S.2236

  • None via MapLight at this time.


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