Senate HELP Committee Releases Report on Proposed FDA Reforms

This article was exclusively distributed to subscribers on February 23, 2026. Click to receive additional information about how to subscribe and to activate a complimentary trial subscription.

On February 17, the Chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, Sen. Bill Cassidy (R-LA), a report outlining a legislative and regulatory framework for modernizing the Food and Drug Administration (FDA). The report, which reflects input from stakeholders, calls for modernizing FDA review processes to improve consistency, embracing innovative evidence models, and accelerating patient access, particularly for rare diseases and emerging technologies, while maintaining strong safety standards.

The report identifies inconsistent and opaque FDA review practices as a major barrier, especially for small and mid-size innovators. The report suggests that FDA expand acceptance of novel clinical trial designs and alternative evidence models, particularly for rare diseases, personalized and precision medicines, and low-risk early phase studies. The committee report highlights that current regulatory frameworks are often ill-suited for rare diseases, where patient populations are small and traditional trial endpoints may be impractical. The committee also recommends that FDA consider broader use of the accelerated approval pathway beyond oncology, noting that the vast majority of such approvals to date have been for cancer drugs.

The report suggests Congress establish a streamlined, intermediate approval pathway for biologics to accelerate patient access to innovative and more affordable therapies. It notes the existing 505(b)(2) pathway for small-molecule drugs, which allows sponsors to rely on prior FDA safety and efficacy findings to expedite review, as a useful model. The committee supports legislation that simplifies the current biosimilar approval framework, including eliminating outdated interchangeability requirements and streamlining study requirements that are unnecessary to demonstrate biosimilarity. Additionally, the report recommends that Congress pass legislation reported by the Senate HELP Committee to curb abuses that delay competition, specifically by allowing FDA to dismiss frivolous citizen petitions intended to stall generic entry and by addressing exclusivity “parking” practices to incentivize timely market entry of competitive generic products. These recommendations are in keeping with the October from the Department of Health and Human Services (HHS), FDA, and Centers for Medicare & Medicaid Services (CMS), which sought to make it faster and less costly to develop biosimilars.

In addition to medical products, the report flags concerns about FDA’s food safety and ingredient oversight, suggesting the agency needs stronger systems to protect public health and respond more effectively to risks in the human foods program.

Recognizing the growing role of artificial intelligence (AI) in product development and review, the report calls on FDA to provide clearer guidance and expectations for the use of AI and other advanced technologies. The committee stresses the importance of regulatory clarity to support innovation while maintaining rigorous oversight.

The report is intended to launch a bipartisan, collaborative process with stakeholders, including the FDA, as the committee prepares for the forthcoming user fee reauthorization process.

For more on the announcement and from FDA, Manatt on Health subscribers can see the November 3, 2025 of Insights This Week.

Click to receive additional information about how to subscribe to and to activate a complimentary trial subscription.