FDA user fees package won’t include any amendments

House Energy and Commerce Committee leaders said late Monday that legislation to reauthorize the Food and Drug Administration’s user fee programs won’t include any amendments, including those passed by the U.S. House of Representatives.

The stripped down version of the legislation is attached to a continuing resolution, which Congress must pass before Sept. 30 to avoid a government shutdown, Energy and Commerce Committee Chairman Frank Pallone, D-NJ, said in a statement.

The user fee programs are a significant source of funding for the agency, allowing it to collect fees on medical device submissions, in exchange for committing to review timelines. The House passed a package in June that included bipartisan provisions, such as cybersecurity requirements for medical devices and clinical trial diversity requirements.

“After the House passed its user fee package, bipartisan Energy and Commerce and HELP leaders came to agreement on language to cover many significant policy areas that we wanted included in the Continuing Resolution. Unfortunately, Senate Republican leadership blocked these policy agreements from being included,” Pallone said.

A separate version of the bill was sent to the Senate with an overhaul of how diagnostics are regulated, and giving the FDA broader authority over supplements and cosmetics. However, leaders of the Senate Committee on Health, Education, Labor and Pensions (HELP) said last week that a “practically clean” version of the bill would be included in the continuing resolution, signaling those provisions are unlikely to make it in the final bill either.

Legislators in both houses said they hope to revisit some of the provisions before the end of the year.

“All four corners committed to returning to the negotiating table ahead of the December government funding deadline to revisit these key priorities,” Pallone said. “I’m going to continue pushing to advance as much of the House-passed legislation as possible.”

Senate HELP Committee leaders Patty Murray, D-Wash., and Richard Burr, R-NC, issued a joint statement on Tuesday saying there is more work ahead to deliver reforms from the FDA and from industry.

“As part of our agreement, we and our House counterparts are committed to continuing that work, and including strong, bipartisan legislation in a robust end of year package,” they stated. MedTech Dive