When newly confirmed US Food and Drug Administration Commissioner Martin Makary enters the halls of a newly-crowded White Oak on 27 March, all eyes will be watching for whether he leans in to the Trump Administration’s actions that destabilized the agency or changes course to reinvigorate morale.
The Senate voted 56-44 on 25 March to confirm Makary, including all Republicans and three Democrats. He was sworn in by Health and Human Services Secretary Robert F. Kennedy Jr. on 26 March.
Like much of the federal government, the FDA has been hit with major workforce changes, and a less than successful return-to-office effort, since President Donald Trump took office on 20 January. The agency also was forced to adapt to an administration that’s often questioning or fully dismissive of scientific reality.
The current environment has frustrated many staff and the changes are starting to impact the speed and quality of FDA’s work.
“I’m sure the workforce will be watching intently to see if he stands up for reasonable treatment of them as opposed to the chaos and unexplained abuse of basic human decency so far,” Robert Califf, President Joe Biden’s FDA commissioner, told the Pink Sheet. “Assuming that fundamental, they’ll be hoping he bases policies on the primacy of high-quality evidence as the guiding light.”
Stand Up For Science
Almost every comment Pink Sheet received about Makary’s confirmation mentioned the hope that Makary will uphold the agency’s high scientific standards.
“With Dr. Makary’s confirmation, we look forward to seeing strong, science-based leadership at the FDA during a time of both immense opportunity and responsibility,” said Ellen Sigal, Chair and Founder of Friends of Cancer Research. “We hope he will prioritize transparency, innovation, and collaboration across sectors to ensure patients benefit from the full potential of scientific progress.”
“A strong, responsive, well-resourced and nimble FDA is vital to our work and to meeting the needs of patients,” a Biotechnology Innovation Organization spokesperson said. “As we’ve said before, public health, economic security and our national security are best served by strong leadership that respects and advances science, nutrition and medicine.”
Nancy Bradish Myers, CEO and founder of Catalyst Healthcare Consulting, said Makary’s “success will depend on shifting the narrative to one of steady, respectful leadership, reassuring staff that FDA’s scientific integrity is non-negotiable and that their talents are appreciated.”
“Effective commissioners listen closely to experienced senior leadership, learn quickly, ask smart questions, and communicate with clarity,” she said. “Most importantly, they protect the mission and the science that underpins it.”
But Will Makary’s Bosses Prevent That?
Some agency experts are not confident Makary will be able to stand up for science and the agency’s typical operating principles.
Kennedy is known for anti-vaccine views and often pushes unproven treatments over scientifically validated cures, including with the current measles outbreak in the US.
“The challenge for Dr. Makary will be balancing his own good instincts about strong evidence and high-integrity process, both of which consume resources, with the difficult situation of being understaffed, underfunded, and dealing with bosses whose primary interest is the outcome,” said Steven Grossman, president of policy and regulatory consultancy HPS Group and author of the FDA Matters blog. He co-founded and is a former executive director of the Alliance for a Stronger FDA.
Makary’s bosses often want a certain outcome even if the evidence or usual process does not support it, Grossman said.
“The best advice is picking your battles wisely, which is easy in theory and hard in practice,” Grossman said. “My own experience in government is that no one really knows for certain how they will handle these types of challenges until they are actually faced with them.”
Makary’s list of challenges is longer than most.
“I don’t think anyone has walked into this much ongoing, fast-paced, administration driven significant change before,” Myers said.
In addition to addressing staff morale, Makary will quickly need to contend with building his leadership team. He already lost his chief counsel pick Hilary Perkins to political concerns related to her prior work on abortion pill-related litigation. No new chief counsel has been named.
Many Biden-era holdovers remain in FDA leadership positions, though the Trump team named current Chief of Staff Jim Traficant and Acting Deputy Commissioner for Human Foods Kyle Diamantas. Most recently, Barclay Butler was named Deputy Commissioner for Operations and Chief Operating Officer.
