Proposed Prescription Drug User Fee Act VII Performance Goals Letter Earns BIO Support
Biotechnology Innovation Organization (BIO) Chief Scientific Officer, E. Cartier Esham issued the following statement on the release of the Prescription Drug User Fee Act (PDUFA) VII performance goals letter:
“The Prescription Drug User Fee Act (PDUFA) continues to enhance and strengthen the U.S. Food and Drug Administration (FDA) in fulfilling its public health mission and ensure that safe, effective, and high-quality new drugs and biological products are reviewed in an efficient and predictable time frame.
“BIO is supportive of the newly-released PDUFA VII commitment letter. We believe it achieves our goals of strengthening scientific dialogue between FDA and industry as well as promoting innovation and a patient-centric review process.
“BIO looks forward to working with the FDA, Congress, patient groups, and all other stakeholders to ensure timely reauthorization of the PDUFA package.”
The PDUFA VII agreement achieves the following objectives:
- Strengthens scientific dialogue between FDA and Industry to promote innovation
- Enhances patient-centric drug review and supports the next wave of advanced biological therapies (i.e., cell and gene therapies)
- Modernizes regulatory and drug development tools, including advancing the use of real-world evidence for regulatory decision-making
- Advances digital technology tools and modernizes FDA’s information technology infrastructure, including the adoption of cloud-based systems and capabilities
- Improves innovation in manufacturing and quality, including lessons learned from COVID-19
- Enhances FDA hiring, retention, and financial management systems
The FDA is announcing a virtual public meeting to discuss the proposed enhancements for the reauthorization of PDUFA for fiscal years (FYs) 2023 through 2027.
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.