Statement: Prescription Drug User Fee Act Reauthorization

WASHINGTON, D.C. (July 15, 2016) – Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl issued the following statement on today’s release of the Prescription Drug User Fee Act (PDUFA) VI performance goals letter:

“The Prescription Drug User Fee Act (PDUFA) is vital to enabling the U.S. Food and Drug Administration (FDA) to fulfill its mission of protecting public health. For nearly 25 years, PDUFA has helped bring innovative medicines to patients by providing greater consistency, certainty and predictability in the U.S. drug review process. The PDUFA VI agreement is an important step forward in ensuring patient safety, maintaining the FDA’s high standards of regulatory review and promoting timely access to safe and effective medicines for patients.  

“PDUFA VI will play a critical role as we continue working together to help patients live longer, healthier lives. With the successful conclusion of the PDUFA VI technical negotiations between the FDA and the biopharmaceutical industry, PhRMA looks forward to working with Congress, the administration, patient and medical provider groups, the FDA and all stakeholders to ensure timely reauthorization of this important program.”

Key provisions about the PDUFA VI performance goals letter:

  • Facilitates science-based integration of the patient perspective into the development and regulatory review of innovative medicines.
  • Enhances the FDA’s access to the tools, processes and expertise necessary to keep pace with the latest scientific advances in drug development and regulation.
  • Helps accelerate the development and availability of new medicines to patients while providing scientific and regulatory predictability that will foster continued biopharmaceutical innovation.
  • Ensures that FDA can hire and retain a strong scientific and medical workforce to advance its public health mission.  

About PhRMA
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested more than half a trillion dollars in the search for new treatments and cures, including an estimated $58.8 billion in 2015 alone.

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