Cliff Stearns: “The authorization of the FDA user fees will simply provide stability at FDA's new product review as companies submit new…”

“The authorization of the FDA user fees will simply provide stability at FDA's new product review as companies submit new and innovative devices and drugs for their approval. I'm especially proud that in this bill I had a piece of legislation called the Faster Access to Specialized Treatments--FAST--Act, which is H.R. 4132. It was included in the FDA Reform Act. This act modernizes the FDA accelerated approval pathways to reflect the 20 years of science developed since accelerated approval was first established in 1992. So think of that: since 1992, with this bill that I've included in our FDA bill, it will accelerate approval through the FDA. It will simply allow new drugs to get to market faster for people who are 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. This act will save lives. I would like to enter, Mr. Speaker, this letter of support for FAST signed by over 150 rare-disease groups into the Record. I'm also glad that the FDA Reform Act includes the Expanding and Promoting Expertise in Review of Rare Treatments Act, EXPERRT Act, H.R. 4156. This will help FDA consult with medical experts when evaluating drugs dealing with rare disease such as cystic fibrosis. As the cofounder of the Cystic Fibrosis Caucus, I'm glad we're giving this tool to the FDA. Mr. Speaker, I support passage of the FDA Reform Act. March 23, 2012. Hon. Cliff Stearns, U.S.…”