House votes to reauthorize FDA user fees; Senate’s up next

Legislation to reauthorize Food and Drug Administration (FDA) user fee agreements passed the House with bipartisan support Wednesday, and the Senate is expected to vote on its version next month, Good Day BIO reported.

H.R.7667, the Food and Drug Amendments Act, passed by a vote of 392-28. It reauthorizes the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA).

“The measure would set a $1.15 billion base fee amount for human prescription drugmakers for fiscal 2023, and revamp the FDA’s accelerated approval pathway,” according to Bloomberg Law. “It also includes provisions to improve diversity in clinical trials.”

Bipartisan effort hailed

The bipartisan effort to develop the package during the floor debate was greeted with appreciation in statements from Energy & Commerce Chair Frank Pallone (D-NJ), as well as Ranking Member Cathy McMorris-Rodgers (R-WA) and Health Subcommittee Ranking Member Brett Guthrie (R-KY).

According to Pallone, “this bill will provide FDA the funding it needs to ensure drugs and devices are safe and effective” and will also “promote the development of new medical products to treat every American, reduce the cost of prescription drugs, and strengthen program integrity at the agency.”

Rep. Guthrie also underscored the importance of FDA fee legislation. “These fees not only permit the FDA to carry out drug or device application reviews, but they also represent a significant percentages of the FDA’s total operating budget without requiring significant taxpayer spending,” he said. “In 2021 alone, 38 of 50 of the world’s novel drugs were first approved in the United States. This was made possible by the Food and Drug Administration Amendments of 2017.”

The Senate Health, Education, Labor, and Pensions (HELP) Committee is scheduled to mark up its version on Tuesday, with a floor vote expected in July, and to ensure timely reauthorization of the user fee programs, the House and Senate will conference the bills in the meantime with the goal of final passage before September 30, Good Day BIO reported.

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