Multiple prospects for FDA reforms outside of the core FDA-industry MDUFA V user fee agreement were raised by lawmakers during a hearing this week. Here we highlight a few that may have the biggest chance of making it into a final package, including measures addressing cybersecurity, diagnostics panels, “remanufacturing” of devices, trial diversity, supply-chain reporting, payor communications, and emerging safety signals.
FDA and industry just spent more than a year negotiating a MDUFA V reauthorization agreement that is now before Congress. While lawmakers will scrutinize the details of the deal in hearings, which kicked off this week, they are ultimately not going to make any changes to the core agreement. The priority is to pass it well before the September 30 deadline to ensure FDA has the resources it needs. (See “MDUFA V Deal Features Add-On Payments, Hiring Targets, and FDA’s TAP,”Market Pathways, March 10, 2022.)
A major focus by lawmakers, however, will be to leverage this short window to attach additional priority reforms to the must-pass legislation. Multiple potential riders were raised during the March 30 hearing on MDUFA V reauthorization convened by the House Energy and Commerce Health Subcommittee. Here’s a roundup of seven measures most likely to make their way into a final package, starting with two bills that were officially entered into the record as part of the Hill session and several others that were discussed during questioning of CDRH Director Jeff Shuren.