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# Senate HELP Committee: 15 Ways to Reform FDA
- URL: https://www.fdaweb.com/senate-help-committee-15-ways-to-reform-fda/
- Published: 2026-02-17T12:00:00.000Z
- Updated: 2026-09-14T13:33:51.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5160678

The Senate HELP Committee has released a report with 15 recommendations for reforming FDA. The [report](ttps://www.help.senate.gov/rep/newsroom/press/chairman-cassidy-releases-landmark-report-to-modernize-fda-deliver-lifesaving-affordable-treatments-to-american-families) says innovation in medical care and treatment is meaningless unless it creates products that actually help patients. “Discoveries that never leave the lab help no one,” it declares. “FDA has enormous leverage over how to channel breakthroughs that can make Americans’ lives better. President Trump’s mandates to cut red tape and make America healthy again challenge FDA, Congress, stakeholders, and patients to work together to examine the extent to which FDA’s regulatory framework works efficiently for American patients and families. While many parts of FDA work well, unnecessary bottlenecks slow patients and consumers getting the products they need.”

The committee says it will initiate a collaborative, bipartisan process for reforms to FDA. This paper, it says, reflects initial input from a variety of stakeholders, including patient advocates, academic researchers, clinical societies, manufacturers, and FDA.

The paper’s major and sub-topics are:

**FDA review of new applications and evidence**

- the need for a more consistent, predictable review process;
- assessing FDA’s approach to clinical trials and alternative evidence models; and
- assessing FDA’s approach to artificial intelligence.

**Support the development of cutting-edge and rare disease therapies**

- FDA’s struggles in leveraging groundbreaking new authorities; and
- reviewing FDA’s rare disease approach.

**Updating FDA’s framework to increase competition and innovation**

- aligning the biologics pathway with current science
- the lengthy path to biosimilar approval; and
- opportunities to increase competition from generic drugs.

**FDA’s framework for software, medical device review, and innovation**

- challenges in predictability and transparency in medical device review;
- challenges with regulatory pathways for software as a medical device;
- unique considerations for medical devices that integrate AI; and
- FDA’s role in regulating clinical decision support (CDS) tools.

**Food safety and innovation**

- review the new human foods program; and
- review of food products and ingredients.

The report’s 14 recommendations are:

- Congress and FDA should apply the least burdensome approach beyond medical devices to other product categories while maintaining patient safety and evidentiary standards;
- to restore early-stage clinical research, FDA should launch a voluntary program in which it pilots a notification pathway for eligible Phase 1 clinical trials;
- as clinical trials continue to evolve from three-phase, site-based studies towards more decentralized and innovative designs, FDA should continue supporting the use of digital health technologies while ensuring that validation requirements for these tools are tailored to their relative risks;
- to ensure that AI standards and frameworks do not conflict, and that FDA grows its talent pipeline, the agency should further its partnerships across HHS agencies while expanding external fellowships;
- FDA should consider how to improve predictability in the drug review process, which should include more judicious use of clinical holds and greater transparency in its dialogue with sponsors;
- Congress should codify recent agency actions to tailor CMC (chemistry, manufacturing, and controls) requirements for therapies intended for small populations;
- to accelerate rare disease drug development, FDA should more consistently use tools like accelerated approval and better coordinate reviews across the divisions and offices;
- Congress should create a new streamlined pathway for biologics through which more innovative and affordable products can get to patients;
- Congress should simplify the current requirements for new biologics, including simplifying the outdated interchangeability designation and streamlining the studies needed to obtain biosimilar approval;
- Congress should pass bills advanced by the Senate HELP Committee to address abuses in the healthcare system that permit FDA to reject frivolous citizen petitions aimed at delaying generic entry and tackling exclusivity “parking” to incentivize timely market entry of competitive generic products;
- Congress should require FDA to provide clearer guidance on the clinical data and evidence needed to support premarket submission, especially for novel, complex health technologies;
- Congress should consider ways to change or supplement the existing medical device review pathway to properly evaluate software so these new products have an efficient and appropriate pathway to market
- Congress should ensure that FDA implements guidance on CDS in the spirit of what it directed in the 21st Century Cures Act;
- Congress and FDA should consider how the agency’s processes to review food products and ingredients could be improved to better empower American families with more confidence and peace of mind; and
- FDA should consider ways to ensure that GRAS (generally regarded as safe) food determinations reflect the best available scientific evidence and work to better communicate these updates to consumers.