Cliff Stearns: “My colleagues, this reauthorization of the FDA's user fees will provide stability for the FDA's new product review as…”

“My colleagues, this reauthorization of the FDA's user fees will provide stability for the FDA's new product review as companies submit new and innovative drugs, medical devices, and biologics for approval. I am especially proud that my bill, the Faster Access to Specialized Treatments, H.R. 4132, FAST, was included in the FDA Reform Act. FAST modernizes the FDA's accelerated approval pathway to reflect scientific developments that have occurred over the past 20 years. This will allow for new drugs 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. FAST will save lives. I am pleased also that the bill includes the EXPERRT Act, H.R. 4156. This will help the FDA consult with medical experts when evaluating drugs designed for rare diseases, such as cystic fibrosis. As the cofounder of the Cystic Fibrosis Caucus, I am glad we are finally providing this tool to the FDA. I obviously support the passage of this bill. Mr. Speaker, the Food and Drug Administration Safety and Innovation Act (S. 3187) is based on user fee negotiations between FDA and the prescription drug, generic drug, biologic, and medical device industry. This reauthorization of the FDA user fees will provide stability with FDA's new product review as companies submit new and innovative devices and drugs for approval.…”