Murray, Burr Reach Deal on FDA User Fee Programs

WASHINGTON — Sens. Patty Murray, D-Wash., and Richard Burr, R-N.C., have struck a deal on language that will allow the reauthorization of the Food and Drug Administration’s user fee program to move forward as part of the continuing resolution Congress must pass by Friday to keep the government open.

In a joint statement Murray and Burr, respectively the chair and ranking member of the Senate Committee on Health, Education, Labor, and Pensions, said the agreement “will ensure that FDA can continue its important work and will not need to send out pink slips.”

They added, however, that there is more work to be done by the current Congress “to deliver the kinds of reforms families need to see from FDA, from industry, and from our mental health and pandemic preparedness efforts.”

“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 said.

Had no deal been reached, the FDA’s user fee programs, which pay the salaries of agency staff who review drug and medical device applications, would have expired on Saturday.

These include the Prescription Drug User Fee Act, Generic Drug User Fee Amendments, the Biosimilar User Fee Act, and Medical Device User Fee Amendments.

The House passed the Food and Drug Amendments of 2022 in May by a vote of 392-28.

A month later, the Senate Committee on Health, Education, Labor, and Pensions advanced its version of the bill, but stark differences existed between the two bills.

For instance, the House bill would expand the FDA’s inspection authorities domestically and abroad, and would require diversity action plans for clinical trials and would also require drug makers to conduct pediatric studies of adult cancer drugs.

The Senate bill, meanwhile, would require the FDA to publish justifications of accelerated approvals and would require baby formula makers to notify the FDA of supply disruptions within a week. It would also allow imports of prescription drugs from Canada.

The version of the Senate bill would also provide the FDA with additional oversight and regulatory requirements for cosmetics, dietary supplements and clinical laboratory developed tests.

In mid-July, Burr introduced a “clean” reauthorization bill, the Food and Drug Administration Simple Reauthorization Act, free of any policy riders. 

But the senator later grew concerned over what he said were “anti-innovation policies” that were adopted during the committee markup. 

Specifically, Burr opposed added language that would, among other things, have allowed the FDA to share brand drug information with generic drug makers, and allowed the FDA to ban certain uses for medical devices.

Last month, as Murray and Burr worked over the language of the two bills, FDA Commissioner Robert Califf suggested the agency still had enough fees on hand to pay the stuff through the middle of October.

Without reauthorization the agency would have been required to notify its employees that they would be laid off.

Energy and Commerce Committee Chairman Frank Pallone, Jr., D-N.J., said Tuesday that the  continuing resolution will reauthorize the FDA user fee agreements for five years to ensure the agency does not need to issue pink slips.  

“In June, the House passed a user fee reauthorization package on time with overwhelming bipartisan support,” Pallone said. “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.  

“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,” he added.

Dan can be reached at dan@thewellnews.com and @DanMcCue