Pathways’ Picks May 11: Hill Action, EU Outlook, and News from FDA and IMDRF

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In this week’s roundup: A House subcommittee unanimously passed the FDA user bill up the chain in Congress, leaving some issues up for future debate, and signals progress on Cures 2.0; on the lookout for key EU implementation items after policymakers meet next week; under pressure from Congress, FDA fleshed out metrics for its planned TPLC Advisory Program, and other agency updates; and the International Medical Device Regulators Forum rolled out new guides.

Top Picks: On the Hill

User fee bill clears first test, Cures 2.0 gets a plug:

Subcommittee advances FDA bill. Legislation to reauthorize FDA’s user fee program, including the device MDUFA V agreement, unanimously passed the House Energy and Commerce Health Subcommittee May 11. Next week, the full committee plans to mark up the bill before it goes to the House floor for debate and a vote. There were significant delays in the FDA-industry device fee negotiations—FDA finally sent Congress its official MDUFA V commitment letter this week (see below, “TAP Metrics Added,” months after a statutory deadline. But the House committee is now making quick work of the package, which also includes drug and biologic user fees and other reforms. It appears ahead of schedule in getting legislation passed well in advance of September, when the current programs expire. Debate during the May 11 markup was most interesting around topics, including device remanufacturing and product shortage reporting, that are not part of the user fee bill. Those could still get attention before the bill reaches a vote by the full House, or in the Senate, which will also need to pass legislation in the coming months.  For more details from the markup session, see: “What’s In and What’s Out? Takeaways from House User Fee Markup,” Market Pathways, May 11, 2022.


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