Senate HELP Chair Cassidy Proposes FDA Reforms, Citing a 'Reviewer Lottery'

Senate Health, Education, Labor and Pensions (HELP) Committee Chair Bill Cassidy (R-La.) has released a report proposing changes to how the US Food and Drug Administration reviews drugs, biologics, medical devices and software. The report, "Patients and Families First: Building the FDA of the Future," was published on Tuesday, February 17, according to Regulatory Focus and the Ripon Advance.

"While many parts of FDA work well, unnecessary bottlenecks slow patients and consumers getting the products they need," Cassidy said in a statement quoted by Regulatory Focus. He added that the committee "looks forward to coordinating with FDA under its new leadership to promote patient access, accelerate U.S. competitiveness, and improve the health of American families."

The report is not legislation. According to the Ripon Advance, Cassidy said the committee plans to begin a collaborative, bipartisan process on FDA reforms, and that the report reflects initial input from stakeholders including patient advocates, academic researchers, clinical societies, manufacturers and the FDA.

Predictability and the "reviewer lottery"

Regulatory Focus reported that the report groups its proposals into four broad areas. The first calls for changes to the premarket application process and evidence requirements to make reviews more consistent and predictable. The report said significant differences between product reviews leave sponsors feeling subject to a "reviewer lottery," and noted that Congress has told the FDA to take a "least burdensome" approach to regulating medical devices, a principle it said lawmakers and the agency should consider applying to other product categories.

The same section calls for more novel clinical trial designs, wider use of real-world evidence and digital health technologies in trials, and a risk-based approach to artificial intelligence. It warned that companies increasingly report starting clinical trials outside the US, including in what it called "adversarial nations like China." On remote monitoring tools, the report said, "Even when FDA has approved or cleared certain remote patient monitors as medical devices, FDA resists their use for data collection in their trials," and that requiring re-validation from study to study creates unnecessary duplication.

The second area covers cutting-edge and rare disease therapies, including criticism of how the agency uses clinical holds. The third would update the regulatory framework for competition, including a proposed intermediate pathway for biologics modeled on the 505(b)(2) route for drugs and changes to the biosimilar pathway, according to Regulatory Focus.

Software, devices and decision support

The fourth area addresses software, device review and innovation. According to Regulatory Focus, the report said device sponsors still struggle with delays, inconsistent review practices and limited real-time engagement with reviewers. It said developers are "eager to see FDA fully embrace Congress' recent directive to leverage predetermined change control plans (PCCPs)," which allow certain postmarket device changes with minimal disruption, and suggested closer coordination with the Office of the National Coordinator for Health Information Technology.

The report recommended that Congress consider ways to improve review pathways for software medical products and that the FDA revisit its risk framework for AI applications and its thinking on clinical decision support (CDS) software. It said a 2022 FDA guidance broadly applied the agency's authority to CDS tools that Congress had carved out of the device definition in the 21st Century Cures Act, and that "Requiring FDA review of these tools will likely stifle and slow advancements in digital health."

The Ripon Advance reported that the recommendations also cover making it easier to bring generic drugs to market, strengthening the FDA's Human Foods Program and attracting scientists and experts to work at the agency.