The Senate has passed the Food and Drug Administration Reauthorization Act (FDARA), a legislative package that supplements FDA funding by requiring manufactures to pay user fees when submitting medical products for review in exchange for a timely approval process.  These user fee agreements are reauthorized every five years and negotiations often take about two years.  Many provisions included in the user fee package will have an impact on rare disease patients, including: making updates to the Pediatric Research Equity Act (PREA) in order to increase the number of children participating in oncology trials, improving the device inspection process, enhancing communication during drug development, and promoting the use real world evidence during regulatory decision-making.

One of the key features of the Prescription Drug User Fee Act (PDUFA), is the inclusion of patient perspectives into the drug development process. An article from the Regulatory Affairs Professionals Society (RAPS) states, “The sixth iteration of the Prescription Drug User Fee Act (PDUFA VI) focuses on pre-market reviews, postmarket safety, regulatory decision tools and other ways FDA is preparing for the future of drug development.”

Click here to read the article from RAPS to learn more about provisions included in FDARA.

Other resources:

March news brief on PDUFA

Video from March Rare Disease Congressional Caucus briefing on PDUFA

Video from our Legislative Conference on PDUFA