Key Takeaways
- According to a June 10, 2025, Journal of the American Medical Association (JAMA) article, the U.S. Food and Drug Administration (FDA) intends to shorten drug approval times and remove unnecessary requirements.
- The FDA is also prioritizing using artificial intelligence (AI) to improve its internal processes.
- The agency has already announced several new initiatives to advance these goals, including a new voucher program that could reduce FDA review times to as little as one-to-two months.
On June 10, 2025, FDA Commissioner Martin A. Makary and Chief Medical and Science Officer Vinay Prasad published an article in the Journal of the American Medical Association titled, “Priorities for a New FDA.”1 The article describes five FDA policy priorities for the current administration: 1) Accelerating Cures 2) Unleashing AI 3) Healthier Food for Children 4) Harnessing Big Data, and 5) Financial Toxicity.
According to the article, the FDA intends to shorten drug approval times and remove unnecessary requirements. The agency will begin reviewing some data before it receives a full marketing application even for applications that are not designated for accelerated approval. It will seek to become “a user-friendly FDA” but to still “guard against a cozy relationship that has characterized the agency in the past and led to allegations of industry capture.”
The FDA has also prioritized using AI to improve its internal processes. After FDA completed a generative AI pilot program with its reviewers to “radically increase efficiency in the review process,” it expanded the generative AI tool, Elsa, across all FDA centers earlier this month. It reports that AI is already helping to accelerate clinical reviews, scientific evaluations, and inspection modeling.2 Elsa has received mixed reviews. Some FDA employees described the tool as “premature and error-prone,” while others praised the potential to reduce the time needed for scientific review.3
In food safety, the agency plans to restrict additives that may contribute to chronic illness, such as petroleum-based dyes and talc. According to Commissioner Makary, “We have begun conducting a full inventory concerning ingredients in the US that are not allowed in other developed countries.” The ingredient review is part of broader plans to make food healthier for children.
Another FDA priority is “Harnessing Big Data” for researching “root causes of chronic diseases” and “postapproval monitoring of new products.” Commissioner Makary writes that “Current systems both wrongly condemn and wrongly exonerate medical products.” The agency will reduce its reliance on randomized, clinical data and seek to use more real-world evidence to measure efficacy and safety more quickly.
“Although the FDA, per statutory law, will not consider price in benefit-risk calculations, the FDA will use its power to address costs.” Consistent with its past policies, the agency will seek to increase price competition by accelerating approval of new generic drugs and biosimilars. According to the article, it will further reduce drug costs by regulating advertising and reduce marketing overhead. The FDA is also “committed to supporting the national priority of most favored-nation pricing of pharmaceuticals, as appropriate.”
Some steps have already been taken to implement the new priorities. A week after the JAMA article, Commissioner Makary announced a new voucher program called the Commissioner’s National Priority Vouchers (CNPV). The CNPV program will provide a nontransferable voucher for approval of a product that advances certain “national priorities,” which can include increasing domestic drug manufacturing, addressing a health crisis in the U.S., bringing potential innovative therapies to the American people, addressing unmet public health needs, or significantly increasing national security of the U.S.4
FDA plans to start giving out new CNPV vouchers in 2025 and may increase the number of vouchers after a one-year pilot phase. Once the vouchers are granted by the FDA, they expire within two years. The voucher can be applied to any drug in any area of medicine or at any stage in development. Currently, the program does not apply to medical devices or combination drug-device products.
When redeemed, the voucher provides enhanced communications with the FDA, interim review throughout the process, and can accelerate FDA review time to as little as one-to-two months. While nontransferable, these vouchers will remain valid through changes in company ownership. The details of the CNPV program are still to be determined, but there are some additional requirements such as submission of manufacturing data and draft labeling in advance of a full marketing application.5
In April 2025, Commissioner Makary also announced a phase-out of animal testing requirements, beginning with monoclonal antibodies.6 And in an interview earlier this year, he previewed a new conditional approval program for rare diseases.7
But the FDA has yet to propose regulations, guidance, or even open a docket for public comment for the new initiatives. As a result, there are still more questions than answers.
[1] Martin A. Makary, MD, MPH & Vinay Prasad, MD, MPH, Priorities for a New FDA, JAMA (June 10, 2025), https://doi.org/10.1001/jama.2025.10116.
[2] FDA, FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People (June 2, 2025), https://www.fda.gov/news-events/press-announcements/fda-launches-agency-wide-ai-tool-optimize-performance-american-people.
[3] News, FDA's AI Assistant 'Elsa' Fails Its First Day on the Job, GV Wire (June 6, 2025), https://gvwire.com/2025/06/06/fdas-ai-assistant-elsa-fails-its-first-day-on-the-job/; Ferdous Al-Faruque, FDA’s Elsa AI tool gets mixed response from some staff, Regulatory Focus (June 4, 2025), https://www.raps.org/news-and-articles/news-articles/2025/6/fda-s-elsa-ai-tool-gets-mixed-response-from-some-s.
[4] FDA, FAQs: Commissioner’s National Priority Voucher Program (June 17, 2025), https://www.fda.gov/news-events/press-announcements/faqs-commissioners-national-priority-voucher-program.
[5] FDA, FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests (June 17, 2025), https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests.
[6] FDA, “Roadmap to Reducing Animal Testing in Preclinical Safety Studies” (Apr. 10, 2025), https://www.fda.gov/media/186092/download.
[7] Tristan Manalac, Makary Discusses Expedited Rare Disease Approvals Pathway, ‘Public Distrust’ in New Interview, BioSpace (Apr. 21, 2025), https://www.biospace.com/policy/makary-discusses-expedited-rare-disease-approvals-pathway-public-distrust-in-new-interview.
