Congress to advance ‘clean’ FDA user fee deal

Lawmakers this week will advance a deal to fund drug and medical device evaluations at the Food and Drug Administration (FDA) for the next five years, but without any additional policy reforms.

The agreement, which will be included as part of broader legislation to fund the government into December, represents a victory for Republican leaders who had insisted on a “clean” user fee bill before moving forward.

The legislation will keep the lights on at the FDA and avoid furloughs, but will not include any additional language for how the agency regulates dietary supplements, lab developed tests, cosmetics or the controversial accelerated approval process for certain drugs.

A House-passed version of the reauthorization included those sweeping regulatory proposals, but Democrats in the Senate agreed to strip them out for now.

However, Democrats also only agreed to extend smaller agency programs that were tangential to the user fees, setting up another battle in December on the year-end funding bill. 

In a joint statement, Senate Health Committee Chairwoman Patty Murray (D-Wash.) and ranking member Richard Burr (R-N.C.) said there will be more negotiations ahead.

“We are glad to announce an agreement to reauthorize the FDA user fee programs, which will ensure that FDA can continue its important work and will not need to send out pink slips. However, there is more work ahead this Congress to deliver the kinds of reforms families need to see from FDA, from industry, and from our mental health and pandemic preparedness efforts,” the lawmakers said.

On the House side, Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) also committed to revisiting the excluded provisions.

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

Drug and device makers pay user fees to the FDA to help speed up product reviews, and in exchange, the agency agrees to meet specific performance goals.