Next iteration of PDUFA will shape biopharmaceutical drug development

SILVER SPRING, Md. - The Food and Drug Administration on Wednesday held a public meeting on the reauthorization of the Prescription Drug User Fee Act for fiscal years 2018 through 2022. The current legislative authority for PDUFA expires in September 2017. 

 

At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years.

 

This will be the sixth reiteration of PDUFA. 

 

"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," both the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization released in a joint statement. "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," the associations noted. "It also initiated the Patient-Focused Drug Development program to better incorporate patient input throughout the drug development and regulatory review processes."

 

But there has been a lot of changes in the drug development process, especially as the biopharmaceutical industry advances, requiring support policies that scientifically integrate the patient perspective in innovative drug development and regulatory decision-making.

 

"PDUFA VI can play a critical role in continuing to advance an effective, science-based U.S. regulatory review program that helps ensure that biopharmaceutical companies can continue to bring innovative medicines to patients," the associations concluded.