House unveils package to reauthorize FDA user fee agreements

The House Energy & Commerce Committee unveiled on Wednesday “a bipartisan comprehensive legislative package to reauthorize the Food and Drug Administration (FDA) user fee agreements,” Good Day BIO reported.

Per the committee’s press release, the package reauthorizes the Prescription Drug User Fee Act (PDUFA) as well as other user fee agreements like the Biosimilar User Fee Act (BsUFA), the Generic Drug User Fee Act (GDUFA), and the Medical Device User Fee Act (MDUFA).

In addition, it includes many provisions “to support patients by lowering costs and providing a clear path for innovators, such as improvements and program integrity for Accelerated Approval, requirements regarding clinical trial diversity, policies to improve generic drug competition,” the press release said.

There are also measures to promote diversity in cinical trials and to encourage improvements in research and the supply chain, a summary of the bill shows.

Good Day BIO said “the Energy & Commerce House Subcommittee is planning on a vote next week, with the goal of sending the bill to President Biden for signature before August.”.

PDUFA is ‘critical to advancing innovation’

Biotechnology Innovation Organization’s (BIO) Chief Scientific Officer Dr. Cartier Esham, who testified in PDUFA hearings before the House and Senate earlier this year, pointed out that “the FDA user fee programs have shown tremendous results in delivering life-saving medicines to patients who urgently need them,” for more than thirty years and noted that she is “pleased to see bipartisan support from the Energy & Commerce Committee for these critical public health programs.”

During the Senate hearing in April, Dr. Esham emphasized in her statement the importance of reauthorizing PDUFA and BsUFA because they, among other things “enable the Agency to keep pace with medical and scientific advancements.”

“PDUFA VII is most critical to advancing innovation, enhancing and strengthening scientific dialogue between sponsors of applications and FDA,”, especially around decentralized clinical trials and digital health tech, which moved forward during the pandemic, she said, according to Good Day BIO.

Dr. Esham also stressed the importance of the FDA’s Accelerated Approval for the companies investing in novel treatments and rare diseases saying that “if it did not exist or it’s not able to function as intended, the path forward for timely access to improved care for these devastating diseases will be limited and delayed,” she said during her Senate testimony.

The draft bill can be seen here. A section-by-section breakdown is available available here.

About The Author

Scroll to Top