SHERIDAN, WYOMING – June 12, 2025 – In a strategic move signaling regulatory reform and modernization, FDA Commissioner Marty Makary and CBER Director Vinay Prasad have outlined a new four-year roadmap for the agency in The Journal of the American Medical Association (JAMA). Their article, “Priorities for a New FDA,” introduces a reform-focused agenda that emphasizes accelerated drug approval timelines, generative AI implementation, and a renewed focus on cost transparency and public health outcomes.
Accelerating Approvals While Guarding Independence
At the heart of the article is a call for a faster, more accessible approval process for novel therapies. Drawing on lessons from the COVID-19 era, Makary and Prasad advocate for piloting “rapid or instant reviews,” aiming to deliver regulatory decisions within weeks. Recognizing that smaller companies often lack in-house regulatory expertise, the FDA plans to provide enhanced guidance, while maintaining safeguards to avoid the perception of industry favoritism.
As stated in the article, “The FDA intends to provide ‘the regulatory navigation that [small] companies may lack internally,’ while at the same time ‘guard[ing] against a cozy relationship that has characterized the agency in the past and led to allegations of industry capture.’” The FDA’s April decision to limit pharma reps’ involvement on advisory committees—despite their previous non-voting status—underscores this shift.
AI Integration to Transform Regulatory Operations
Another core pillar of the FDA’s vision involves the integration of artificial intelligence to streamline processes and boost operational efficiency. Referencing the agency’s internal AI initiative, the authors wrote: “The advent of generative AI also ‘holds several promises to modernize the FDA and radically increase efficiency in the review process.’”
This transformation is already underway. The FDA recently announced it would deploy a new AI system—Elsa—across departments by June 30. Notably, “Last week, the FDA revealed that it would roll out this new tool, named Elsa, ‘ahead of schedule and under budget.’”
Addressing Chronic Disease and Food Policy
In alignment with broader public health goals, the article takes aim at rising rates of chronic illness and food safety. Echoing Health Secretary Robert F. Kennedy Jr.’s platform, Makary and Prasad wrote, “We will transition from a purely reactionary health care system to one that is proactive, intellectually curious about underlying causes, and financially aligned to promote health—not just treat sickness.” They emphasized restoring focus on food standards, writing that the agency will “restore focus on the ‘F’ in FDA.”
Cost Transparency and Pharmaceutical Competition
While legally restricted from factoring price into benefit-risk decisions, the FDA signaled it will take a more active role in promoting affordability. Makary and Prasad addressed “financial toxicity” directly, stating: “Although the FDA, per statutory law, will not consider price in benefit-risk calculations, the FDA will use its power to address costs. These include expediting generic medications and massively streamlining the burden to develop biosimilar compounds.”
On the same day the article was published, the FDA reinstated its previously dismantled Office of Generic Drugs—an operational move that signals renewed commitment to expanding competition.
A Politically Charged Publishing Choice
Their decision to publish in JAMA is notable given recent controversy. Just two weeks prior, Secretary Kennedy publicly criticized the journal, calling it “corrupt” and influenced by the pharmaceutical industry, alongside The Lancet and The New England Journal of Medicine. He even suggested banning federal scientists from publishing in these outlets. Despite this, the FDA leaders’ decision to use JAMA reflects a strategic effort to engage directly with the medical community through mainstream scientific forums.
Omitted but Noted: Silence on Vaccines
One absence noted by Leerink Partners in its investor note was the lack of commentary on vaccines—a particularly sensitive issue in light of Kennedy’s dismissal of all 17 remaining members of the CDC’s Advisory Committee on Immunization Practices (ACIP). The article’s omission stands out amid broader public and investor scrutiny on vaccine-related policies.
Conclusion
Makary and Prasad’s JAMA article signals a proactive transformation of the FDA’s regulatory framework, combining technological modernization, policy transparency, and a strong stance on regulatory independence. For life sciences companies, the message is clear: the FDA is embracing efficiency, innovation, and equity—while asserting its independence from industry influence.
Learn more at www.fda.gov