BIO/PhRMA view progress on PDUFA reauthorization

Reauthorization of the US Prescription Drug User Fee Act (PDUFA) has made meaningful improvements to the regulatory program, say trade groups Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO).

In a joint statement, they noted that, “for more than 20 years, PDUFA has helped the Food and Drug Administration fulfill its central mission of protecting and promoting public health by allowing the agency to keep pace with the rapid increase in the number and complexity of innovative drugs and biologics requiring regulatory review.”

“PDUFA V refocused the program on its original intent – patient access to life-saving medicines. It made meaningful improvements to the human drug review program such as increased communication between FDA and biopharmaceutical companies during drug development and regulatory review to promote regulatory transparency and predictability. It also initiated the Patient-Focused Drug Development program to better incorporate patient input throughout the drug development and regulatory review processes,” they stated.