User Fee Bill Hits the Hill

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ARTICLE SUMMARY:

Legislation to reauthorize FDA user fees was unveiled in the House May 4 by Reps. Anna Eshoo (D-CA) and Brett Guthrie (R-KY). Excerpted from Pathways’ Picks, May 4, 2022.

The package incorporates the MDUFA V device user fee framework agreed between FDA and industry last month, and reported on in detail in Market Pathways. Our MDUFA-focused Market Pathways Scorecard infographic sums up the core financial and performance goal elements captured in the bill, including conditional add-on user fee payments. Lawmakers also included an array of reforms beyond the core user fee agreements in the bill that have been previously underscored as priorities. Most notably, the bill would:

  • Mandate device, and drug, companies to submit a “diversity action plan” for planned clinical trials specifying goals and strategies for enrolling a representative patient population
  • Require FDA to issue guidance on “decentralized” trials, where study activities can take place remotely levering digital health tools
  • Allow virtual FDA inspections of device firms by giving the agency authority to request and inspect records “in advance or in lieu of” a facility inspection for some devices. FDA set up a Remote Regulatory Assessments program during the pandemic, but those don’t count as an official inspections
  • Requires FDA to issue more guidance on using real-world evidence, in particular on applying real-world data collected for COVID-19 emergency use authorized products to support traditional submission reviews
  • Establish statutory cybersecurity requirement for medical devices (PATCH Act)
  • Clarify that companies can share data and information with payors before a product is approved and not run afoul of off-label marketing rules

The legislation does not include several other reform priorities that have been raised by lawmakers including, most notably, any language to expand FDA device shortage reporting authority, diagnostic regulatory reform, or defining the term “remanufacturing.” The first opportunity for additional amendments to the bill will be next week when the Energy and Commerce Health Subcommittee will mark up the package. After that, the full committee will get its turn, and the Senate will advance its own version of user fee legislation before a final measure can be enacted.

Excerpted from “Pathways’ Picks May 4, Pathways’ Picks May 4: Big FDA News Week, EU IVDR Countdown, and More,” Market Pathways, May 4, 2022.

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Regulatory & Reimbursement

What’s In and What’s Out? Takeaways from House User Fee Markup

The FDA user bill passed its first congressional test May 11, gaining unanimous subcommittee approval. The markup session was more interesting, though, for discussion on topics not included in the bill. Key takeaways: industry-supported device “remanufacturing” legislation appears less likely to join the user fee bill, while product shortage reporting requirements that worry device firms are still on the table.

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