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 FDA user fee programs for prescription drugs and medical devices, including biosimilars and generics.

HR 7667, also known as the Biosimilar User Fee Amendments of 2022, was introduced by Representative 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 advance the measure.

“This legislation would reauthorize FDA’s user fee programs, which are critically important to ensure the agency has the funding it needs so that Americans can continue to trust that the drugs and medical devices they use are safe and effective…. This comprehensive package also includes important provisions that will help lower 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 Health Subcommittee markup of 6 bipartisan bills, including HR 7667.

User fee programs for biosimilars, as monitored under the Biosimilar User Fee Act, are used to support the review of biosimilar product applications, including hiring staff, improving systems, and maintaining a well-managed program to optimize patient access to these medications. User fees are collected from applications and the FDA is responsible with 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 for its human drug and biosimilar biologic review programs. A major problem with these programs was that unexpected workload increases did not result in comparable increased in user fees collected from manufacturers who submitted applications for new drugs to be reviewed, leading to the FDA experiencing a funding shortfall.

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