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Amicus CEO Represents BIO on Rare Diseases at U.S. Senate Committee on Health, Education, Labor and Pensions Bipartisan Hearing
Date:7/21/2010

CRANBURY, N.J., July 21 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: FOLD) announced today that the Company's Chairman and CEO, John F. Crowley, testified on behalf of the Biotechnology Industry Organization (BIO) at the Senate Committee on Health, Education, Labor and Pensions bipartisan, full committee hearing focused on rare and neglected diseases held on Wednesday, July 21 on Capitol Hill. Mr. Crowley, a member of the Board of Directors of BIO, provided background and perspectives on the current state of drug development for orphan products. He also made a series of recommendations to the Committee regarding the establishment of additional incentives for companies to develop more treatments for rare and neglected diseases.

During his testimony, Mr. Crowley discussed the unprecedented success of the Orphan Drug Act (ODA) of 1983 and its market-based incentives for biotechnology and pharmaceutical companies to develop products for rare diseases. Crowley made several recommendations on new policies for the Committee's consideration to accelerate the development of treatments for rare and neglected diseases that will complement and advance the objectives of the ODA and facilitate the availability of the next generation of orphan products for children.  

These recommendations included:

  • Improving the U.S. Food and Drug Administration (FDA) regulatory environment for pediatric rare diseases;
  • Establishing a separate Division of Genetic and Metabolic Disorders at FDA;
  • Urging FDA to publish further guidance regarding increased use of surrogate endpoints for pro
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