BILL INCLUDES STEARNS’ PROPOSAL TO MODERNIZE FDA’S APPROVAL OF NEW DRUGS AND TREATMENTS AND A BILL FOR FDA CONSULTATION WITH OUTSIDE EXPERTS ON RARE DISEASES

WASHINGTON, MAY 30, 2012 – The House today approved H.R. 5651, the Food and Drug Administration Reform Act, which includes the provisions of two bills offered by Stearns: H.R. 4132, the Faster Access to Specialized Treatments (FAST) Act; and H.R. 4156, the Expanding and Promoting Expertise in Review of Rare Treatments Act (EXPERRT) Act.  “I’m grateful to my fellow House members for approving my two bills that were added to the FDA Reform Act during committee consideration.  These two bills will make the FDA more effective in improving the availability of new drugs, treatments, and expertise for the American people.”

Explained Stearns, “the FAST Act modernizes the FDA Accelerated Approval pathway to reflect the 20 years of science developed since Accelerated Approval was first established in 1992.  This will allow new drugs to get to market faster for people suffering from rare diseases.  There are 30 million Americans suffering from one of over 7,000 rare diseases but only 250 currently have any treatment.  In addition, the EXPERRT Act will help FDA consult with medical experts when evaluating drugs dealing with rare diseases, such as Cystic Fibrosis.  As the cofounder of the Cystic Fibrosis Caucus, I’m glad we’re giving this tool to FDA.”

More than 150 rare disease groups have endorsed the FAST Act and Stearns efforts on behalf of those with rare diseases and disorders.  The National Organization for Rare Disorders (NORD) recently recognized Stearns with its National Health Leadership Award for his work to reform the FDA.