House Panel Advances FDA Reauthorization with Device Amendments

The House Energy and Commerce Committee voted 54-0 on June 7 to advance the FDA’s five-year user fee reauthorization package to the floor of the House — with several new amendments on devices.

The next generations of MDUFA is expected to bring in $183 million in fiscal 2018, up from the $126 million expected this fiscal year. Overall, the agency’s user fees account for more than one quarter of the FDA’s annual budget.

The panel approved by voice vote several device-related amendments, including:

• An amendment from Rep. Jan Schakowsky (D-Ill.) that would require the FDA to create a voluntary pilot program to develop post-market safety data on medical devices;
• An amendment from Rep. Mimi Walters (R-Calif.) that would allow the FDA to create a risk-based classification system for current device accessories without the added scrutiny of treating a simple device accessory like a device modification;
• An amendment by Rep. Scott Peters (D-Calif.) that would create a clear regulatory pathway for new diagnostic imaging devices intended for use with contrast agents; and
• A bipartisan amendment from Peters and Rep. Ryan Costello (R-Pa.) requiring the FDA to better define the agency’s oversight and regulation of reconditioned medical devices and submit a report, within 180 days, detailing how the agency intends to ensure the quality, safety and continued effectiveness of devices serviced—meaning refurbishing, reconditioning, rebuilding, remarketing, remanufacturing or repairing—by someone other than the OEM.

The Senate’s version of the user fee bill is also currently awaiting a floor vote. After both chambers pass their respective bills, they will reconcile any differences before final passage. The must-pass bill is expected to land on President Trump’s desk sometime in July. The FDA’s current user fee agreements expire at the end of September. 

User fees affect drug competition at every level. And user fees are a hot topic during the current budget cycle. Order your webinar CD/Transcript of Impact: FDA User Fees, Drug Competition and Pricing — An Inside View today.