Statement in Support of the Prescription Drug User Fee Act (PDUFA)
The Sjögren's Syndrome Foundation strongly urges the reauthorization of the Prescription Drug User Fee Act (PDUFA) to ensure timely approval of new and safe medications by the U.S. Food and Drug Administration (FDA). Millions of patients, including those who suffer from the second most common autoimmune rheumatic disease, Sjögren's, will suffer needlessly if PDUFA is not reauthorized.
Because of the increased number and complexity of drugs entering regulatory review in this modern era, user fees are critical to enable the FDA to keep pace with the approval process. Before the initial passage of PDUFA in 1992, most medicines were approved outside the U.S. due to the lengthy time it took to get drug reviews through the FDA. Following PDUFA, drug approval time was reduced in half and more than 1500 drugs have been authorized by the FDA. PDUFA encourages scientific innovation and makes it possible for our country to bring new treatments to market for the many patients who desperately need them.