- The House of Representatives passed legislation late Wednesday to reauthorize the Food and Drug Administration user-fee amendments for five more years.
- The House version of the bill includes provisions that would require drug and device manufacturers to develop a plan for clinical trial diversity early in the development process, which they would submit to the FDA. It also would bolster cybersecurity requirements for medical devices.
- The Senate Committee on Health, Education, Labor and Pensions (HELP) is expected to work on its version of the bill, which includes an overhaul of how diagnostics are regulated, next Tuesday.
By a 392-28 vote, the House passed legislation that would reauthorize the FDA’s user-fee programs for medical devices and drugs through 2027. In total, the bill would allow the FDA to bring in $1.78 billion over the next five years to fund its review of medical devices, which could increase to $1.9 billion if the agency meets certain hiring goals.
Legislators have been working to get the bill passed before the end of September, when the current user-fee legislation expires. They got a later start on the medical device portion of the bill when the FDA was two months late in getting an agreement to Congress.
In a previous hearing, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, explained the delay was because of the pandemic and the time it took to work through “lots of perspectives” in the medical device industry.
Scott Whitaker, CEO of the medical device lobby group AdvaMed, praised the House’s passing of the bill in a Thursday statement, saying that the “MDUFA V agreement includes firsts for greater accountability, predictability, consistency, and communication to increase patient access to safe, effective medical innovations.”
The House version of the bill includes requirements around clinical trial diversity for drug and device makers. It would require a device sponsor to submit a diversity action plan in premarket reporting that includes their goals for enrollment in a clinical trial, why they set those goals and how they plan to meet them. It would also require the FDA to issue draft guidance on diversity action plans within a year of the bill’s passage.
The bill also includes several cybersecurity provisions for medical devices. It would require manufacturers to develop processes to ensure their devices are secure, have plans to address and identify cybersecurity vulnerabilities and include a software bill of materials in the device labeling, which would list off all of the software components of the device. Manufacturers would share this information with the FDA as part of premarket submissions.
The FDA also would have authority to exempt some types of devices from these cybersecurity requirements, and to deny 510(k) clearance for a device if inadequate cybersecurity information is provided.
A Senate draft of the bill differs from the House version, though the two could still be merged. The Senate version would expand the FDA’s regulatory authority around cosmetics and supplements. It also incorporates legislation that would change how diagnostics are regulated, bringing laboratory-developed tests under FDA review.
The Senate HELP Committee is scheduled to mark up the bill on June 14.