New House Bill Could Expand User Fee Programs for Biosimilars


A new bill that would amend the federal Food, Drug and Cosmetic Act aims to expand the FDA’s user fee programs for prescription drugs and medical devices, including biosimilars and generics.

HR 7667, also known as the 2022 Biosimilar User Fee Changes, was introduced by Rep. Anna Eshoo (D-California) and Health Subcommittee Ranking Member Brett Guthrie (R- Kentucky). It was referred to the House Committee on Energy and Commerce. According to Bloomberg Law, the committee voted 30-0 to move the measure forward.

“This legislation would reauthorize the FDA’s user fee programs, which are critically important to ensuring the agency has the funding it needs so Americans can continue to have confidence that drugs and devices drugs they use are safe and effective…. This comprehensive package also includes important provisions that will help reduce drug costs for the American people by promoting competition,” said Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-New Jersey) during his opening remarks at a 6-partisan health subcommittee markup. invoices, including HR 7667.

Biosimilar user fee programs, as overseen under the Biosimilar User Fees Act, are used to support the review of biosimilar product applications, including hiring staff, l improving systems and maintaining a well-managed program to optimize patient access to these drugs. User fees are collected from applications and the FDA is responsible for ensuring that they are sufficient to cover expenses.

When the COVID-19 pandemic hit, the FDA was looking to revise its methodology for determining the needs of its review programs for human drugs and biosimilar biologics. A major problem with these programs was that unexpected increases in workload did not result in a comparable increase in user fees collected from manufacturers submitting new drug review applications, leading to a funding shortfall. for the FDA.

“The Food and Drug Administration’s user fee agreements enable the agency to fulfill its mission to review and approve the drugs Americans rely on…. As we continue to grapple with the pandemic of COVID-19, adequate funding and staffing levels at the FDA are more important than ever. Patients rely on the FDA’s gold standard for safety and effectiveness, and the American people rely on us to ensure the agency has the resources it needs to improve development, review applications and monitor drug safety in a timely manner,” Eshoo said in a statement.


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