Adam Lee
Thermo Fisher Scientific
United States
A High-Level Overview of Drug Policies in the House Appropriations Bill
The New House appropriations report was released, which provides important directives to the FDA. Although no new regulation has been enacted, the bill outlines directions from the federal government that might serve as indicators of how the FDA will govern in the future. Outlined below is a look on the report’s language around just two subjects: AI in drug development and the modernization of cell and gene therapy processes. Additionally, several other subjects are briefly summarized.
AI in Drug Development
The Committee expressed strong support for the FDA's efforts to address artificial intelligence (AI) and urges the Commissioner to formalize a dedicated, cross-center team of AI experts. This team should include experts with a deep understanding of machine learning algorithms, data preprocessing, predictive modeling, and model validation for drug development. Their role will be to ensure reliability and trustworthiness of AI models on complex biological datasets.
The potential of AI in any industry is hard to overstate. With the federal government not only encouraging but also requiring a specialized team, it will only foster innovation for the drug development space. In an optimistic assessment, this move can accelerate the development of new drugs by leveraging AI technologies, ultimately benefiting patients with quicker access to advanced treatments.
FDA has already taken steps to implement AI-assisted scientific review seriously. Per agency news release, Commissioner Martin A. Makary announced that all FDA centers will deploy AI tools to “reduce the amount of non-productive busywork that has historically consumed much of the review process.” The rollout, led by Chief AI Officer Jeremy Walsh and Sridhar Mantha, aims to enhance functionality to adapt to evolving needs and more efficient agency reviews.
Cell and Gene Therapy Modernization
The Committee commends the FDA's prioritization of cell and gene therapies. FDA is encouraged to continue modernizing its approach by incorporating innovative clinical trial designs that reflect the diverse patient populations who could benefit from these therapies. The agency is urged to establish modern pathways that embrace novel endpoints for safety and efficacy assessment, ensuring appropriate evaluation of benefits and risks. Interestingly, the Committee also encourages enhanced alignment regarding risk tolerance. For conditions where these therapies offer significant clinical outcomes, a broader risk-benefit assessment may be applied beyond viewing these as rescue therapies. It’s noted that Cell and Gene therapies can be more than a last resort, and the risk-benefit analysis should reflect this range. The Committee recommends utilizing accelerated development pathways for therapies addressing significant unmet patient needs. RFK Jr. has also echoed this sentiment regarding Cell and Gene Therapy.
This direction, or at the very least, attention, implies the acceptance of Cell and Gene therapy. Congressional requests regarding Cell and Gene therapy only encourage even faster groundbreaking advancements in treating life-altering conditions, ultimately improving patient outcomes.
Brief Overview of Other Subjects
The table below captures additional, but not an all-inclusive list of subjects, that were also mentioned in the House Appropriations Bill that may be of some interest to Drug Developers.
| Subject |
Content |
| Accelerated Approval Program |
Concern that the application of the Accelerated Approval Program is not uniform between CDER and CBER. The FDA is asked to detail steps that the FDA can take to ensure the Accelerated Approval Program is administered equally between CDER and CBER. |
| Advanced Manufacturing Standards Development |
The Committee recognizes that facilitating greater adoption of advanced manufacturing technologies is an important strategic objective for the nation. The Committee encourages the Commissioner to develop a plan to coordinate efforts with external experts in the development of industry standards to overcome technical challenges to wider adoption and implementation of advanced manufacturing technologies. The Committee requests an update on this plan no later than 90 days after the enactment of this Act. |
| Alzheimer’s Clinical Trials |
The Committee recognizes the need for innovative clinical trial designs to increase diversity in clinical trials for Alzheimer’s disease. FDA is encouraged to increase efforts to make Alzheimer’s clinical trials more inclusive and innovative and to conduct necessary outreach to underrepresented populations. |
| Bacterial Endotoxins Testing |
The Committee directs the FDA to update its 2012 Guidance for Industry on Pyrogen and Endotoxins Testing by publishing revised draft guidance within one year of enactment of this Act to include acceptance of appropriate recombinant Bacterial Endotoxins Testing methods for endotoxins testing for new and existing products. |
| Rare Diseases |
The Committee is concerned that there are disparate approaches to similar rare disease treatments between centers that pose risks to innovation. While autonomous, the Committee urges CDER and CBER to align their approach to rare disease drug approvals to the greatest extent possible. |
References
1. "H. Rept. 119-172 - AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS BILL, 2026." Congress.gov, Library of Congress, 28 July 2025,
https://www.congress.gov/committee-report/119th-congress/house-report/172/1
2. "FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout." FDA, U.S. Food and Drug Administration, https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai
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