FDA user fee agreements advance in House with bipartisan support

The House Energy & Commerce Health Subcommittee on Wednesday marked up six key bills that address the FDA user fee agreements and some other health priorities, Good Day Bio reports.

The Food and Drug Amendments of 2022 (H.R. 7667) passed out of committee with a bipartisan vote of 30-0. In addition, the subcommittee forwarded the Advanced Research Project Agency-Health (ARPA-H) and legislation related to mental health, pediatric research, and South Asian heart health awareness, according to Good Day Bio.

The reauthorization of the FDA user fee agreements enjoys bipartisan support, and the leadership of the committee and subcommittee from both parties deemed these agreements “critical to ensure drugs are safe and effective and speed life-saving innovations to patients,” Good Day Bio says.

Accelerated approval, inclusive trials

Cathy McMorris Rodgers (R-WA), the Committee Republican leader, said that the bill “preserve[s] the promise and the hope of the Accelerated Approval Pathway and what it brings to patients and their families while ensuring [post-approval studies] are conducted in a timely manner.”

The legislation would also ensure “clinical trials are inclusive and representative of the patients that sponsors intend to serve,” Committee Chair Frank Pallone (D-NJ) said.

All of the bills are scheduled for a full committee markup next week, Good Day Bio reports.

Dr. Cartier Esham, BIO’s Chief Scientific Officer testified earlier that “BIO appreciates the package and looks forward to its advancement, as FDA is critical to advancing innovation.”

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