Senate HELP Committee Releases FDA Modernization Report: “Patients and Families First: Building the FDA of the Future”
Overview
On February 17, 2026, the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP), chaired by Senator Bill Cassidy (R-LA), published a white paper outlining proposed reforms to the U.S. Food and Drug Administration (FDA). Developed with input from patient advocates, researchers, clinical societies, and manufacturers, the report proposes areas where FDA’s regulatory framework may be strengthened to accelerate patient access to safe and effective products. This advisory summarizes the report’s principal topics and recommendations.
FDA Review Processes and Clinical Evidence
The report raises FDA’s review of new product applications as a central challenge, particularly for smaller companies. Currently, stakeholders describe a “reviewer lottery” in which review processes—including the timeliness of communications, responsiveness to questions, and flexibility on study design—vary significantly depending on the assigned review team. In contrast, the Oncology Center of Excellence is highlighted as a model of collaborative, dialogue-based review.
Separately, the report recommends extending the “least burdensome” principle—currently applied to medical devices, requiring only the minimum information necessary to address a regulatory question—to additional product categories. On clinical trials, the report notes the U.S. is losing its competitive position due to longer timelines and comparatively higher regulatory burdens for low-risk, early-phase trials, which drive sponsors to initiate first-in-human studies abroad. The report states that other countries enable trials to begin up to three times faster by streamlining oversight and eliminating regulatory redundancies, with China surpassing the United States as the top venue for clinical trials. It suggests FDA consider a voluntary pilot for low-risk Phase I studies modeled on Australia’s notification-based approach, and calls for expanded use of real-world evidence, decentralized trials, and alternative preclinical methods.
Artificial Intelligence
With respect to the emerging relevance and integration of artificial intelligence (AI), the report calls for a risk-based, targeted approach to regulating AI across both drug and biologic development and medical device review, cautioning against duplicative requirements in areas already covered by existing safeguards such as the Investigational New Drug (IND) review process. The report notes that FDA’s current AI action plan focuses primarily on machine learning and does not yet address generative AI. It recommends broadly applicable FDA guidance to ensure consistent treatment of AI across review divisions, international harmonization of AI standards, and expanded internal AI expertise through hiring, fellowships, and external partnerships. Considerations specific to AI-enabled medical devices are addressed further in the Medical Devices and Software section below.
Cell and Gene Therapies and Rare Disease
The report cites that FDA has approved 48 cell and gene therapies through December 2025, with over 4,000 gene, cell, and RNA therapies in development. The report notes stakeholder concern over increasing use of clinical holds by the Center for Biologics Evaluation and Research (CBER). Approximately 30 million Americans are affected by more than 7,000 rare diseases, roughly 95% of which lack any approved treatment. The current regulatory framework is described as ill-suited for personalized and “n-of-1+” products (i.e., therapies designed for extremely small patient populations, sometimes as few as a single patient). FDA’s January 2025 announcement of flexible chemistry, manufacturing, and controls (CMC) requirements and its July 2024 Rare Disease Innovation Hub are noted as positive developments.
Biologics, Biosimilars, and Generic Drugs
The report notes that current biologics pathways lack an intermediate option comparable to the 505(b)(2) pathway for small molecule drugs. Products such as “biobetters” and modified biosimilars currently require a full Biologics License Application even where prior safety and efficacy data exists. Through the first 10 months of 2025, FDA approved 75 biosimilars to 11 reference products. The report highlights FDA’s October 2025 guidance clarifying that clinical efficacy studies are not routinely required for biosimilarity, and notes FDA leadership’s view that all biosimilars should be considered interchangeable. On generics, the report references recent HELP Committee legislation aimed at reducing delays to generic competition.
Medical Devices and Software
The report describes challenges in device review, including inconsistent practices and a disconnect between CDRH leadership and individual reviewers. Approximately 99% of devices reach market through the 510(k) pathway, while the De Novo pathway for novel devices can require clinical data comparable to a Premarket Approval (PMA) application. For software as a medical device (SaMD), the existing framework does not accommodate the dynamic nature of continuously updating software. The report notes that product developers are eager for FDA to fully embrace predetermined change control plans (PCCPs), which allow developers to make certain postmarket improvements to their devices with minimal disruption. FDA’s 2017–2022 Software Pre-Certification pilot concluded with mixed results.
On AI-enabled devices, the report notes that FDA’s current action plan does not yet address generative AI. Regarding clinical decision support (CDS) tools, stakeholders raised concerns that FDA’s 2022 guidance asserting oversight over CDS software may conflict with the exclusion Congress established in the 21st Century Cures Act (P.L. 114-255). The report acknowledges that FDA has since published revised CDS guidance but maintains that the agency should continue to exercise its authority within the bounds of what Congress directed in the Cures Act.
Food Safety and Innovation
The report reviews FDA’s consolidation of food safety functions into a new Human Foods Program (HFP), effective October 1, 2024. On food ingredients, many Generally Recognized as Safe (GRAS) determinations and food additive approvals have not been reviewed for decades. For example, since 2010, FDA determined only 15 ingredients to not be GRAS. The report also highlights slow review timelines for genetically engineered foods under the Coordinated Framework for the Regulation of Biotechnology, with developers reporting wait times of two or more years compared to weeks or days in other developed countries.
Key Recommendations
The report’s recommendations span FDA’s full regulatory scope:
• extending the “least burdensome” principle beyond medical devices;
• piloting a notification pathway for Phase I trials;
• creating an intermediate biologics approval pathway;
• simplifying interchangeability and biosimilar study requirements;
• codifying tailored CMC requirements for small-population therapies;
• improving review predictability and judicious use of clinical holds;
• updating device review pathways for software;
• aligning CDS guidance with the 21st Century Cures Act;
• modernizing GRAS review; and
• evaluating the effectiveness of the Food Safety Modernization Act.
We will continue to keep you informed on proposed reforms to the U.S. Food and Drug Administration and related matters. Buchanan’s FDA & Biotechnology Team and Government Relations Group are here to assist with any changes impacting your business.
The full report can be found at:
www.help.senate.gov/imo/media/doc/fda_report.pdf
The press release can be found at:
www.help.senate.gov/rep/newsroom/press/chairman-cassidy-releases-landmark-report-to-modernize-fda-deliver-lifesaving-affordable-treatments-to-american-families