McMorris Rodgers leads effort to unveil sweeping FDA user fee reforms

U.S. House Energy and Commerce Committee Ranking Member Cathy McMorris Rodgers (R-WA) joined a bipartisan group of her committee colleagues in introducing a comprehensive bill to reauthorize the Food and Drug Administration (FDA) user fee agreements.

The Food and Drug Amendments of 2022 would amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, among other purposes, according to the text of the bill.

House E&C Committee Chairman Frank Pallone, Jr. (D-NJ), along with committee members Brett Guthrie (R-KY) and Anna Eshoo (D-CA), joined Rep. McMorris Rodgers in proposing the bill, which they said will be marked up next week in the House E&C Health Subcommittee. 

“The Food and Drug Amendments will allow FDA to continue its critical mission of reviewing and approving drugs and medical devices that save lives and improve the quality of life for Americans,” Rep. McMorris Rodgers and her colleagues said in a joint statement released on May 4. “We are proud of this final agreement and the hard work by all our colleagues that went into building bipartisan consensus on a bill that achieves so much and can earn broad support in Congress.”

If enacted, the bill would reauthorize the Prescription Drug User Fee Act, the Generic Drug User Fee Act, the Biosimilar User Fee Act, and the Medical Device User Fee Act, according to a bill summary provided by the lawmakers. 

In addition, the bill includes numerous provisions led by the E&C Committee members that lower costs and provide a clearer path for innovators, such as improvements and program integrity for accelerated approval, requirements regarding clinical trial diversity, policies to improve generic drug competition, and authorities to strengthen supply chains through accountability in FDA’s inspections programs, the summary says.  

“In addition to providing FDA with authority to collect user fees to fulfill its mission, the bill includes new provisions that will strengthen the accelerated approval pathway and help ensure clinical trials better represent the diverse patients that need these products,” said the lawmakers. “The agreement will also lower drug costs through more competition and improve oversight of supply chains.”  

Rep. McMorris Rodgers and her colleagues said they will continue to work together to finalize the bill in the coming weeks, starting with a vote in the Health Subcommittee next week. 

“We look forward to advancing this legislation out of the committee soon so that we can send a final bill to the president’s desk for signature before August,” they said.