Announcement of PDUFA Agreement in Congress Supports Biomedical Innovation, Helps Patients

Biotechnology Industry Organization (BIO) President and CEO, Dr. Michelle McMurry-Heath, released the following statement following the announcement that Congress reached an agreement on the Prescription Drug User Fee Act (PDUFA):

“For 30 years, PDUFA has been absolutely critical to equipping the Food and Drug Administration (FDA) with the tools they need to safely and efficiently review innovative drugs and biologics that Americans rely on to live healthy lives.

“BIO has long touted the importance of PDUFA, and we’ve been very vocal about the need for timely reauthorization this year. While we eagerly await final passage, the announcement of a deal to reauthorize the user fee agreements paves the way for continued stability for the FDA and its ability to usher in the next generation of medicines and safeguard public health. The importance of this mission has never been made more clear than the work the agency carried out during the COVID-19 pandemic.

“A newly finalized agreement will also bring some much-needed stability to biopharma companies working on the next generation of cures. This is especially crucial for the small and mid-sized companies responsible for the lion’s share of biomedical innovation. According to the Congressional Budget Office, small drug companies now account for more than 70 percent of the nearly 3,000 drugs in phase III clinical trials.  It will also ensure continued transparency and consistency within the FDA for new drug approvals, thereby streamlining the process to bring breakthrough drugs and therapies to vulnerable patients.

“BIO, on behalf of our member companies, thanks leaders in Congress for their efforts toward completing the reauthorization of PDUFA. We will continue looking for ways to support our companies in their shared goals of pushing the boundaries of biomedical innovation and bringing groundbreaking cures to patients.”