July 9, 2025
Commissioner of the U.S. Food and Drug Administration (FDA) Martin Makary, MD, MPH and Director of the FDA’s Center for Biologics Evaluation and Research (CBER) Vinayak Prasad, MD, MPH recently outlined their vision for the FDA in a JAMA article. The article, “Priorities for a New FDA,” outlines a transition for the FDA from “a purely reactionary health system” to a proactive one.
The authors state that the revised focus is a response to continued chronic health issues among the U.S. population, despite the U.S. leading the world in “sophisticated cell and gene therapies and other innovative treatments.” The aim to reexamine America’s food and health system and address root causes of chronic disease largely aligns with the purpose of the Make America Healthy Again Commission (MAHA) and some of the priorities outlined in the Commission’s Make Our Children Healthy Again Assessment. Makary is on the MAHA Commission, so the similarities are not surprising.
FDA’s new priorities
Makary and Prasad highlight five overarching priorities for a new FDA. First is the need to increase the speed of the review process for marketing approvals, particularly for medical devices and pharmaceuticals. The FDA plans to launch pilot programs that leverage agency expertise across departments to deliver sponsors a decision in a matter of weeks rather than months.
This streamlined process will require sponsors to submit certain paperwork before their final application. This will allow regulators to examine manufacturing plans, draft labels, and packaging in advance, thus shortening the review process for the final clinical trial results.
The FDA also plans to use its recently announced Commissioner’s National Priority Voucher (CNPV)program to shorten the average review time from 10-12 months to 1-2 months. Only companies “that are aligned with the national health priorities” of the U.S. will be eligible to participate in the CNPV program. The agency will use specific criteria to vet companies.
The second priority is unleashing artificial intelligence (AI) to “modernize the FDA and radically increase efficiency in the review process.” The FDA also plans to modernize its review of AI-based technologies to balance safety and accuracy while fueling innovation. Additionally, Makary and Prasad highlight an FDA roadmap to reduce animal testing using AI-based computational modeling.
Another priority is healthier food for children, with an initial focus on auditing food ingredients. The authors note several recent actions by the FDA to address concerns around certain food ingredients, including removing nine petroleum-based food dyes from the U.S. food supply and beginning work on defining ultra-processed foods. Efforts to achieve the goals around this issue will likely align closely with the MAHA Commission and the priorities of Health and Human Sciences (HHS) Secretary Robert F. Kennedy Jr.
Makary and Prasad also identified harnessing “Big Data” as another key priority to enhance the FDA’s operations. They envision using this tool to research root causes of chronic diseases and to support post-approval monitoring of new products. The authors note that Big Data will allow the FDA and researchers to monitor safety signals in real time and evaluate effectiveness of a product in the real world. This type of information is particularly important for products where pre-market randomized trials may not be feasible, such as drugs for rare diseases.
The final priority is addressing “financial toxicity” or the high price of drugs in the U.S. While statutory law does not allow the FDA to consider price in benefit-risk calculations, Makary and Prasad write that the FDA will use its power to address costs. This may be achieved through expediting generic medications, streamlining the burden to develop biosimilar compounds, or supporting most-favored-nation pricing of pharmaceuticals when appropriate.
Looking ahead
While Makary and Prasad outline five key priorities, there is a common thread throughout—a desire to speed the review process and promote innovation, while creating better health outcomes for Americans. The implementation of these top priorities is mostly undefined for now, but it will likely have implications for product approval timelines and post-market obligations across the medical device, pharmaceutical, and food sectors.
These potential changes present both opportunities and risks for manufacturers. On one hand, a more streamlined review process can get life-saving products to market faster and the use of real-world surveillance can improve outcomes for certain products. However, the increased use of AI and data will require greater data integrity and may raise concerns around how the FDA manages proprietary data submitted by individual companies. In addition, any agency influence on pricing could impact companies’ bottom lines if they are forced to cut the retail price of their products.
The FDA’s emphasis on increased transparency from companies and stricter oversight of the relationship between the FDA and industry could also create new risks. Businesses may need more robust documentation of their processes and should regularly review and update their recall and crisis plans. Taking a proactive approach to risk assessment will be key to weathering this evolving regulatory environment.
