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

WASHINGTON, JUNE 20, 2012 – The House today approved the final version worked out with the Senate on S. 3187, the Food and Drug Administration Safety and Innovation Act.  Two bills offered by Rep. Cliff Stearns (R-FL) were added to the FDA legislation during consideration of the House version in the Energy and Commerce Committee.  The two bills are 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 that the House and Senate kept my provisions in the final version of the bill,” said Stearns.  “These provisions 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.  In addition, the National Organization for Rare Disorders (NORD) honored Stearns with its National Health Leadership Award for his work with FAST.