Why reauthorization of PDUFA matters

Last night, the Prescription Drug User Fee Act (PDUFA), was reauthorized by the House of Representatives. PDUFA provides the U.S. Food and Drug Administration (FDA) with necessary resources to meet performance goals for the regulatory review of new medicines. PDUFA has helped the U.S. maintain its global leadership in regulatory review and introduction of safe, effective new medicines.

Reauthorizing of PDUFA will enhance FDA’s efficiency and bring innovative, lifesaving treatments to patients. Already, thanks in part to the PDUFA program, more than 1,500 new drugs and biologics, including treatments for cancer, rare diseases, cardiovascular, neurological and infectious diseases have been brought forward to patients.

As the Senate now considers this important legislation, here are a few resources to help better explain why PDUFA is good for patients: 

• Find out how PDUFA benefits patients and advances medical innovation in this fact sheet.
• Get the facts on how PDUFA harnesses real-world evidence to provide patients with innovative, new medicines.
• Read about ways PDUFA seeks to incorporate the patient voice into the drug evaluation process, and learn why this critical to developing new medicines.

America’s biopharmaceutical researchers and scientists are continually working to advance science and find new treatments and cures for some of the most vexing diseases of our time. PDUFA along with the Biosimilar and Generic Drug User Fee Acts is crucial to patients in need of life-saving treatments and enhancing the competitive market in biopharmaceutical innovation.

Learn more and get the facts at PhRMA.org/PDUFA.