ARTICLE SUMMARY:
In this week’s roundup: A House committee scrutinizes FDA user fee agreement, and more from the Hill; AdvaMedDx chief moves to lab association; FDA seeks a CMO; Biden issues budget request; Medicare sequester and spending; CMS looks to Transitional Coverage of Emerging Technology program; updates from Europe and Saudi Arabia, and more.
Capitol Hill Picks
User fee hearing and more from Congress this week:
FDA pressured on MDUFA delay. The more than two-month delay in delivering a MDUFA V user fee agreement to Congress damaged the transparency of the policy-setting process and might prompt reforms in the negotiation and reauthorization process, leaders of the House Energy and Commerce Committee told CDRH Director Jeff Shuren during a March 30 hearing. For more details on what lawmakers said at the E&C Health Subcommittee hearing about this issue and potential reforms, see “Lawmakers May Push Reforms to How User Fees are Reauthorized,” Market Pathways, March 30, 2022.)
Riders to watch. While some lawmakers probed details of the draft MDUFA V user fee agreement that FDA circulated last week, a lot of time at the House hearing was directed at additional reforms that could be added to a broader user fee package. Market Pathways identified seven issues in particular from the hearing that show a reasonable chance of getting attention in final FDA reauthorization that passes later this year. Among them are cybersecurity, diagnostics oversight, and “remanufacturing” of devices. For more details, see “7 User Fee Rider to Issues to Watch: From Cybersecurity to Remanufacturing to Payor Comms,” Market Pathways, March 30, 2022.)
