H.R.4156 - Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012

To amend the Federal Food, Drug, and Cosmetic Act to strengthen the ability of the Food and Drug Administration to seek advice from external experts regarding rare diseases, the burden of rare diseases, and the unmet medical needs of individuals with rare diseases. view all titles (3)

All Bill Titles

  • Short: Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 as introduced.
  • Short: EXPERRT Act of 2012 as introduced.
  • Official: To amend the Federal Food, Drug, and Cosmetic Act to strengthen the ability of the Food and Drug Administration to seek advice from external experts regarding rare diseases, the burden of rare diseases, and the unmet medical needs of individuals with rare diseases. as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
03/07/12
 
 
 
 
 
 
 

Sponsor

Senator

Edward Markey

D-MA

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Official Summary

Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 or EXPERRT Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to establish a program for consultation with external experts to inform and strength

Official Summary

Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 or EXPERRT Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to establish a program for consultation with external experts to inform and strengthen the Food and Drug Administration's (FDA's) review of drugs and biologic products for rare diseases and drugs and biologic products that are genetically targeted. Requires, under such program, each review division within the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research to seek the opinion of external experts on topics that may include:
(1) rare diseases;
(2) the severity of rare diseases;
(3) the unmet medical need associated with rare diseases;
(4) the willingness and ability of individuals with a rare disease to participate in clinical trials;
(5) an assessment of the benefits and risks, including side effects, of current and investigational therapies;
(6) the design of clinical trials for rare disease populations and subpopulations; and
(7) demographics and the clinical description of patient populations. Allows external experts to request the opportunity to meet with a review division regarding any such topic. Authorizes the Secretary to determine the timing of each consultation, which may occur prior to, or following, the filing of an investigational new drug application, a new drug application, or a biologies license application. Requires the experts consulted to be considered special government employees.

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