With Commissioner Marty Makary’s exit, the FDA will enter a period of “unprecedented” and “prolonged” leadership vacuum, analysts at Capital Alpha predicted, noting that the government will have trouble finding someone who will want to take the FDA’s reins.
After a tumultuous tenure, FDA Commissioner Marty Makary has officially resigned from his post as the U.S.’s top drug regulator. Finding someone to follow him will be a tall order, experts say, given the controversies that have hounded the agency in recent months.
“Everybody wants that job,” President Donald Trump told reporters Tuesday afternoon after he confirmed that Makary was no longer with the agency, according to the Washington Post. But Capital Alpha analysts disagree, writing in a note that “the administration might struggle to find a suitable candidate who will want the job.”
In the meantime, the FDA’s top food executive Kyle Diamantas will lead the agency.
“Makary oversaw what must be the most damaging period in FDA history,” Capital Alpha added. Since being confirmed in March 2025, Makary oversaw a massive exodus of staff: by July 2025, the agency had shed some 3,500 employees, sacked or driven away by cuts imposed by Health and Human Services Secretary Robert F. Kennedy, Jr.
These personnel problems stretched even to the highest rungs of the FDA. Under Makary’s leadership, the Center for Drugs Evaluation and Research cycled through four directors: Jacqueline Corrigan-Curay, who left in June 2025; George Tidmarsh, who was forced out in November 2025; Richard Pazdur, who retired in December; and the center’s current acting head Tracy Beth Høeg.
The Center for Biologics Evaluation and Research similarly has been in turmoil with its former head Vinay Prasad, a controversial pick to begin with. Prasad oversaw some contentious decisions at the FDA, including the agency’s initial outright refusal to review Moderna’s mRNA flu vaccine (a move that has since been reversed) and the rejection of Disc Medicine’s bitopertin—a verdict that reportedly stemmed from Prasad’s skepticism.
Prasad was also reportedly under investigation for fostering a toxic workplace. He stepped down at the end of April.
“The commissioner likely hastened his own demise by repeatedly defending Prasad,” Capital Alpha analysts wrote in its Tuesday note, adding that, “Ultimately, we see the uncertainty and drama Makary’s tenure courted as largely pointless.”
With Makary gone, “FDA faces an unprecedented, and what’s likely to be prolonged, leadership vacuum,” the group forecast.
Other analysts also focused on the prolonged leadership instability at the FDA and the impact on drugmakers. “We see today’s news as likely renewing an overhang at a time when biopharma had been performing relatively well,” RBC Capital Markets told investors on Tuesday evening.
Despite the controversies at the FDA, “Dr. Makary had at least provided nominal stability at the top of the agency and had been associated with a set of pro-industry programs to help expedite drug development,” the analysts added. Chief of these, they continued, is the Commissioner’s National Priority Review Voucher (CNPV) program, which is supposed to shorten review times to 1-2 months for companies that align with certain federal priorities.
Makary’s FDA also enacted the plausible mechanism pathway for personalized therapies for rare diseases and the one-trial policy for drug applications.
RBC called these programs “pro-innovation initiatives” that “we had viewed as broadly favorable for the industry.” With Makary out, the future of these programs is now up in the air and will largely depend on his successor.
“Who ultimately leads the agency more permanently will have a major impact on the FDA’s overall direction,” the analysts added.
Truist Securities expected Makary’s departure to be met with enthusiasm but reminded investors that there are larger policy issues that could be impacted by the lack of leadership.
“While we expect an initial positive knee‑jerk reaction from therapeutic investors to Makary’s departure—given the perception that he was not industry‑friendly ... it is important to consider the broader ripple effects of these developments, especially considering Makary’s departure comes at a sensitive time in the PDUFA VIII reauthorization negotiations,” Truist wrote on Wednesday morning.
Truist questioned if a “more traditional, business-friendly” FDA commissioner could be appointed with Kennedy still at the helm. The new commissioner will need to be Senate-confirmed, which could take time.
“In a protracted scenario without formal leadership, we’d expect more delays and unpredictability out of the FDA given lack of guidance and divergent views at the division level of the agency,” Truist wrote.
