Today the Senate passed the FDA Reauthorization Act (FDARA) including the user fee program reauthorization. FDARA puts patients first by giving the FDA the resources it needs to swiftly approve new medicines, medical devices and diagnostics. Every five years, this legislation has been reauthorized with significant bipartisan support. This year FDARA includes provisions that will advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions.
For the last 25 years, the pharmaceutical drug user fee has helped the FDA streamline and enhance its drug approval process, helping patients access life-saving medicines in a timely manner. The reauthorization of medical device user fee will also enable FDA to continue its critical mission of ensuring safe and effective medical devices and diagnostics remain available to patients everywhere. FDARA also includes the reauthorization of the biosimilars user fee which will create a more robust and competitive marketplace for biosimilar therapies.
iBIO thanks Senators Duckworth and Durbin and the bi-partisan support in the Senate and House of Representatives to reauthorize this bill. Thank you for reauthorizing PDUFA so that patients get the access to the medical innovations they need and the FDA can keep approving drugs and devices that save lives and increase competition.