SWHR Recommendations to FDA for PDUFA Reauthorization for FY 2023-27

SWHR provided comments as a follow-up to the U.S. Food and Drug Administration (FDA) public meeting regarding the proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023-2027. In advance of PDUFA VI’s expiration in September 2022, SWHR offered the following recommendations:

  1. Apply lessons learned from the COVID-19 pandemic to strengthen the agency’s approach to decentralizing clinical trials and making research participation more available to an increasingly diverse range of patients.
  2. Coordinate the FDA approach to digital health technologies in order to support the decentralization of clinical trials and to increase participation of diverse patient groups within research.
  3. Better integrate real-world data (RWD) and real-world evidence (RWE) within agency drug approval and decision-making initiatives.
  4. Continue efforts to gather patient input on drug development and to prioritize diverse patient voices to the greatest extent possible.
  5. Improve inclusion of pregnant and lactating women within clinical trials.
  6. Continue FDA’s focus on hiring and retaining experienced, highly qualified staff.

PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. When current legislative authority for PDUFA expires in 2022, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. SWHR’s comments follow the July 23, 2020, public meeting FDA hosted to gain input on plans for reauthorization. SWHR plans to continue to engage with the FDA in the coming months as part of the reauthorization process.

Read SWHR’s recommendations

SWHR provided comments as a follow-up to the U.S. Food and Drug Administration (FDA) public meeting regarding the proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023-2027. In advance of PDUFA VI’s expiration in September 2022, SWHR offered the following recommendations:

  1. Apply lessons learned from the COVID-19 pandemic to strengthen the agency’s approach to decentralizing clinical trials and making research participation more available to an increasingly diverse range of patients.
  2. Coordinate the FDA approach to digital health technologies in order to support the decentralization of clinical trials and to increase participation of diverse patient groups within research.
  3. Better integrate real-world data (RWD) and real-world evidence (RWE) within agency drug approval and decision-making initiatives.
  4. Continue efforts to gather patient input on drug development and to prioritize diverse patient voices to the greatest extent possible.
  5. Improve inclusion of pregnant and lactating women within clinical trials.
  6. Continue FDA’s focus on hiring and retaining experienced, highly qualified staff.

PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. When current legislative authority for PDUFA expires in 2022, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. SWHR’s comments follow the July 23, 2020, public meeting FDA hosted to gain input on plans for reauthorization. SWHR plans to continue to engage with the FDA in the coming months as part of the reauthorization process.

Read SWHR’s recommendations