The Academy of Physicians in Clinical Research (APCR) Board of Trustees unanimously adopted official policy supporting the reauthorization of the Prescription Drug User Fee Act (PDUFA) by the US Senate. PDUFA V was last reauthorized, on July 9, 2012, as part of the Food and Drug Administration Safety Innovation Act and is authorized through September of 2017. On August 3, 2017 the US Senate reapproved PDUFA for another five years as part of the Food and Drug Administration Reauthorization Act in a vote of 94-1.
The PDUFA was created by Congress in 1992 and authorizes the Food and Drug Administration (FDA) to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug review process. PDUFA was enacted to address concerns about unacceptable delays in the FDA regulatory review of new medicines. At that time, the United States had one of the slowest review and approval processes in the developed world, and as a result, patients experienced delays accessing new therapies. PDUFA has provided the FDA with stable and predictable funding by supplementing Congressional appropriations with pharmaceutical manufacturer user fees that allow the FDA to more quickly bring new medicines to patients. PDUFA must be reauthorized every five years.
The APCR supports the fast and efficient regulatory review by the FDA when reviewing new drugs and biologics. To accomplish this, APCR advocates for the timely reauthorization of PDUFA by the United State Congress. Pharmaceutical manufacturer user fees provide the FDA with stable and predictable funding that allows the FDA to safely and efficiently decrease drug review periods while enhancing safety and efficacy standards. PDUFA maintains a continued focus on patient safety, high standards for regulatory review, and promoting timely access to safe and efficient innovative medicines for patients. APCR calls upon the FDA to proactively address long term needs as the number of innovative drugs and biologics entering the development and regulatory pipeline rapidly increases.
To see the official APCR policy, click here.