FDA user fee legislation covers accelerated approval, clinical trial diversity

The full House Energy & Commerce Committee marked up six health-related bills on May 18, including the reauthorization of the FDA user fee legislation.

The House Energy & Commerce Committee voted unanimously (55-0) to advance the FDA user fee reauthorization legislation, which the Health Subcommittee marked up last week. The bill, Food and Drug Amendments of 2022, consists of faster approval procedures and provisions to increase the diversity of clinical trials.

The legislation would “improve FDA’s review of drugs, biologics, and medical devices,” said Rep. Frank Pallone (D-NJ), the Committee Chair. “The bill will also reduce drug costs, improve program integrity and oversight in the accelerated approval program, and improve diverse representation in clinical studies.”

The bill “would strengthen the FDA’s power to ensure there are clear conditions for completing confirmatory trials and gives regulators the authority to require studies to be underway before approval is granted,” Axios reported last week.

“The accelerated approval pathway is key to innovation and making sure innovators have certainty in their application process, and is a good policy,” said Rep. Larry Bucshon, M.D. (R-IL).

The Senate released its version of the FDA user fee reauthorization earlier this week, which notably “does not address either accelerated approval reforms or clinical trial diversity,” reports Endpoints News.

Watch highlights of the hearing:

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