Why was PDUFA created?

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect user fees from persons that submit certain human drug applications for review or that are named in approved applications as the sponsor of certain prescription drug products.The act was designed to provide a stable source of funding for the agency, which could be used to hire more staff and improve the efficiency of the drug review process. The creation of PDUFA was motivated by several factors. One key factor was the growing backlog of new drug applications at the FDA, which had reached record levels in the early 1990s. This backlog was causing significant delays in the approval process, which could have negative consequences for patients who were waiting for new treatments. Another factor that contributed to the creation of PDUFA was the desire of the pharmaceutical industry to have a predictable and efficient regulatory pathway for their products. The industry saw PDUFA as a way to help ensure that they would not face unpredictable delays or additional requirements during the review process.PDUFA must be reauthorized every five years. On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022, which includes the reauthorization of PDUFA through September 2027. Overall, the creation of PDUFA represented an important step forward in efforts to improve the efficiency and effectiveness of the drug approval process in the United States.