From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of sound bites, featured two standout sessions: Food and Drug Administration (FDA) Commissioner Dr. Martin A. Makary on Day 1 and Congressman (D-Mass) Jake Auchincloss on Day 2. Their talks, of course, revealed stark differences in approach—Dr. Makary’s forward-looking optimism and Mr. Auchincloss’s calls for concern—yet shared a commitment to advancing innovation and protecting the core of the agency. To be sure, much of what was said (aside from Dr. Makary’s now widely reported-on comment about a new vaccine framework) was not new, but there are a number of industry takeaways when viewed together and in the context of the conference itself.
FDA Commissioner Dr. Martin A. Makary: A Push for Integrity
Dr. Makary focused on restoring trust in the “brand” of the FDA and was empathetic to the people that do the every day work of the agency. He emphasized the difficulty coming in “after” the reductions in force, but pledged to “restore and rebuild” the culture to the best of his ability. This theme was spread throughout Dr. Makary’s remarks. He also stressed agency independence, advocating for policies like limiting advisory committee roles for industry employees to reduce conflicts of interest, but underscored “strong partnerships” with industry in appropriate ways, intimating positive views on user fee programs. Dr. Makaray’s vision includes accelerating approvals with randomized controlled trials and real-world evidence, while maintaining product safety. The “gold standard science and common sense”, in his view, is here to stay, and to be clear, according to Dr. Makary, there will be no reorganization of FDA.
Dr. Makary also spoke at length about the new AI initiative at FDA, announced last week and widely publicized, which will aim to incorporate AI tools for application reviews. The example case was for review of myriad scientific literature appendices in applications that can take days—now minutes—for reviewers to pour through. Dr. Makary also discussed cloud-based endpoints and industry collaboration to further modernize review processes, particularly for predictive toxicology in drug development. Near the end of the session, Dr. Makary teased the new “framework for vaccine makers”, without much more context, in the coming days. Overall, Dr. Makary’s focus on transparency and streamlined, evidence-based approvals signals a regulatory environment that values innovation but demands robust data.
Congressman Jake Auchincloss: A Call to Action
On Day 2, Mr. Auchincloss, a member of the Energy and Commerce Committee, took a more critical tone, framing the FDA’s challenges in both a local and global-political context. He dismissed modernization efforts like DOGE as “dumb,” and lamented HHS Secretary Robert F. Kennedy Jr.’s characterization of FDA personnel as industry “sock puppets.” Mr. Auchincloss urged Congress to provide “political top cover” for the FDA—and Dr. Makary—ensuring bipartisan support to shield the agency’s critical work from political interference, focus on science and public trust, and avoid erosion of public sentiment of the agency.
Mr. Auchincloss also highlighted very real and very present global competition, warning that China is “eating our lunch” in life sciences innovation, particularly in preclinical and phase 1 research. Focus on cutting budgets is contrary to this plight. He pushed for increased R&D investment—suggesting 6% of GDP—and further underscored that we need coordinated efforts across various agencies to “build” better than China in life sciences. On rare and pediatric disease topics, Mr. Auchincloss highlighted recent news about CRISPER therapies and projected that the bipartisan Give Kids a Chance Act would pass. Overall, Mr. Auchincloss’s remarks underscore the need to uphold health and human safety through good science in a politically charged landscape while advocating for policies that bolster U.S. competitiveness.
Takeaways and Common Ground
FDLI did a great job at juxtaposing these sessions—but the perspectives, on the whole, were not substantively opposed, and at times, seemed very much aligned. Both spoke supportively about the FDA’s “gold standard” and the importance of the global marketplace advantage that the US currently holds in the life sciences sector. It would not be a stretch to say that each speaker appears to support the notion that a strong FDA is a good thing. Each speaker also recognized that these are critical elements of the agency and should be protected at all costs. Reading between the lines, moreover, it would be fair to say that each speaker shares a view that the user fee process and engagement with industry is important and should not be scrapped, contrary to what has been reported elsewhere at HHS about the user fee systems.
Similarly, there was a mutual focus on innovation—whether it be AI or R&D investment more broadly—but to be sure, each speaker had their own view on which means of innovation was more important. Even on “efficiency,” the speakers did not seem too far apart. “Modern and efficient”, in Mr. Auchincloss’ words, seemed to match well with Dr. Makary’s view that some change was needed but drastic measures would be counterintuitive to the mission.
The FDLI 2025 Conference underscored that while regulatory and political leaders may differ in approach, their endgame—fostering innovation while protecting public health—aligns. That is also a good thing.