Actions and Detail Panel
Prescription Drug User Fee Act 201 Partner Meeting
Wed, April 5, 2017, 10:00 AM – 12:00 PM EDT
The goal of PDUFA is to supplement congressional appropriations so that the FDA can hire staff, improve systems, and establish a better managed human drug review process to make important therapies available to patients sooner without compromising the review quality or the FDA's high standards for safety, efficacy, and quality. By providing predictability in the review process, PDUFA can be an important tool in encouraging additional investment by biopharmaceutical companies. And added investment means more jobs. Biopharmaceutical companies in Maryland support nearly 26,000 jobs generating nearly $8 billion in wages. The current authorization of the program (PDUFA V) expires in September 2017. In these trying times, we must take advantage of any opportunity to not just guard those valuable jobs, but to create new ones.