FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s priorities, including accelerating cures and the rapid deployment of artificial intelligence.
Literary partners Marty Makary and Vinay Prasad picked up the proverbial pen again Tuesday, publishing a new article focused on the FDA’s priorities in the Journal of the American Medical Association—incidentally, a publication that just two weeks ago, Health Secretary Robert F. Kennedy Jr. threatened to bar government scientists from publishing in.
The piece, “Priorities for a New FDA,” co-written by the FDA commissioner and Center for Biologics Evaluation and Research director, outlines the officials’ roadmap for the next four years, based on the guiding principles of “gold-standard science and common sense.”
Of particular interest to the biopharma industry are sections on “accelerating cures” and artificial intelligence.
Citing the “rapid or instant reviews” that occurred during the COVID-19 pandemic, Makary and Prasad “aim to pilot programs to deliver sponsors a decision in weeks.” 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 colleagues wrote. In April, the FDA announced it was moving to limit pharmaceutical representatives from serving as members on its independent advisory committees. Notably, these were already non-voting members.
The advent of generative AI also “holds several promises to modernize the FDA and radically increase efficiency in the review process,” Makary and Prasad wrote, pointing to the agency’s May announcement that it would deploy AI across the agency by June 30. Last week, the FDA revealed that it would roll out this new tool, named Elsa, “ahead of schedule and under budget.”
“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,” the regulators wrote.
Notable for Leerink Partners, which released a note to investors late Tuesday evening, is that the article contained no mention of vaccines—a topic that has dominated biopharma and healthcare news cycles this week after Kennedy jettisoned all remaining 17 members of the CDC’s Advisory Committee on Immunization Practices (ACIP). (The committee’s co-lead, Lakshmi Panagiotakopoulos, had already resigned in protest of Kennedy’s recent decision regarding COVID-19 vaccination recommendations for healthy children and pregnant women, made in advance of an ACIP vote scheduled for later this month.)
Leerink also called out Makary and Prasad’s focus on “financial toxicity,” a section in which they write, “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.” In a possibly related mea culpa, the FDA on Tuesday reinstated its generic drug policy office after previously gutting the team in April.
The regulators went on in the JAMA article to confirm their commitment to “supporting the national priority of most favored-nation pricing of pharmaceuticals, as appropriate.” President Donald Trump signed an executive order on drug pricing reform last month and has tapped CMS Administrator Mehmet Oz to lead the effort, which experts have said may have limited reach.
The overarching theme of the JAMA piece, however, is focused on hot-button issues for Secretary Kennedy, including the rise in chronic diseases among children and his mission to make food healthier. The agency will “restore focus on the ‘F’ in FDA,” Makary and Prasad write.
That the top FDA officials are writing in JAMA at all is something of a surprise, given that last month, Kennedy threatened to ban government scientists from publishing in this journal, along with the New England Journal of Medicine and The Lancet. Speaking on the “Ultimate Human” podcast, Kennedy highlighted these three prominent medical publications as being “corrupt” and influenced by the pharmaceutical industry.
