Placeholder Banner

Proposed Prescription Drug User Fee Act VII Performance Goals Letter Earns BIO Support

August 24, 2021
Media Contact

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.

About BIO

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.

Discover More
Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), released the following statement after the House of Representatives passed the Build Back Better Act: “The legislation that passed the House today…
The Biotechnology Innovation Organization (BIO) today announced the launch of Clinical Trials: The Power of Participation (CTPoP), a website that addresses how clinical trials work, how to enroll in a clinical trial, and what to expect as a clinical…
Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization (BIO), made the following statement: "Last week, Democratic leaders announced they had reached a drug pricing “deal.” We wanted to see the details before…