Looking ahead to PDUFA VI

Next Monday, PhRMA and BIO will participate alongside patient advocates and key stakeholders in the U.S. Food and Drug Administration’s (FDA) public meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA VI).

Established in 1992 to address concerns about unacceptable delays in the FDA’s regulatory review of new medicines for patients, PDUFA has provided greater consistency, certainty and predictability for the FDA’s human drug review program and has helped bring over 1,500 new safe and effective innovative medicines to patients. PDUFA VI builds upon the successes of previous PDUFA agreements with continued focus on ensuring patient safety, maintaining the FDA’s high standards for regulatory review and ultimately promoting timely access to safe and effective innovative medicines, including treatments for patients with rare, serious or life-threatening diseases.

PhRMA looks forward to working with Congress, the administration, patient and medical provider groups, the FDA and all stakeholders to ensure timely reauthorization of this important program. PDUFA is a shining example of successful public policy, and its reauthorization will support biopharmaceutical innovation and help to bring the next generation of new medicines and potential cures to patients.

Want to learn more about PDUFA VI and its key provisions? Check out our PDUFA VI fact sheet and recent blog post What you need to know about PDUFA VI.