A new report from RBC Capital Markets lists Biotechnology Innovation Organization chief executive John Crowley and military physician Heidi Overton as potential candidates for the role of FDA commissioner—in addition to the agency’s current acting leader, top food regulator Kyle Diamantas.
John Crowley, CEO of the Biotechnology Innovation Organization, is naturally everywhere at BIO’s 2026 International Convention in San Diego this week. But the rare disease advocate and former chief executive of Amicus Therapeutics also holds a prominent place on RBC Capital Markets’ latest list of potential FDA commissioner picks.
The potential candidates for the FDA’s top job, put out by RBC in a Wednesday note to investors and compiled “based on reports and our sources,” also includes the current interim commissioner, Kyle Diamantas, who took over in an acting capacity for Marty Makary after he was forced out of the role on May 12.
Diamantas has gotten rave reviews from multiple stakeholders for stabilizing the agency after a year of tumult under Makary. He has “earned the respect of career staff and the FDA stakeholder community,” Scott Faber, senior vice president of the Environmental Working Group, told STAT News late last month. However, RBC argued that the “ultimate permanent Commissioner is more likely to be a subject matter expert/bureaucrat with industry backing,” making Diamantas an unlikely choice.
A more likely candidate is Heidi Overton, according to RBC, which placed the former physician and health policy official within the U.S. military and Department of Defense health system near the top of the list. RBC cited Bloomberg as its source, referring to an article published Tuesday reporting that the Trump administration is “zeroing in” on Overton as a leading candidate for FDA commissioner. Overton is currently deputy assistant to the president for domestic policy, per Bloomberg.
RBC wrote that Overton’s potential impact on biopharma in the role would be “uncertain” and “depend heavily on direction from RFK, Jr. and White House.” She is “not a known champion of pro-innovation programs (CNPV, one-trial), but also not on record opposing them,” the analysts added.
Second on RBC’s list, Crowley “has been publicly vocal on FDA reform, accelerating drug approvals, reducing regulatory barriers, and defending biotech innovation,” the firm wrote, “including speaking out on the need for U.S. biopharma competitiveness relative to China in early 2026.” Indeed, Crowley touched on this issue at BIO on Tuesday during a media address.
While the BIO CEO was complimentary of China’s rise as a biotech powerhouse, he said U.S. policy needs to protect and maintain America’s lead. “They’ve provided very great science, great services. We need to make sure, though, that we don’t fall into the trap of what they’re trying to create, which are these inescapable dependencies, where more and more we become dependent,” Crowley told media representatives, including BioSpace Senior Editor Annalee Armstrong.
As FDA commissioner, Crowley’s potential impact on biopharma would be “likely very positive,” according to RBC, “particularly for rare disease companies.” However, the analysts wrote, “His deep ties to industry could . . . raise questions about perceived impartiality on approvals, and a BIO-affiliated commissioner may face skepticism from patient safety advocates and Democratic senators.”
The 2010 movie “Extraordinary Measures” is based on the efforts of Crowley and his wife Aileen to save their children, who have Pompe disease, a potentially fatal rare genetic disorder that causes severe muscle weakness. John Crowley was the first CEO of Amicus, which was acquired by BioMarin last December for $4.8 billion. Amicus markets Pombiliti, a two-component therapy for Pompe.
RBC also noted that Crowley has “recently expressed a view that the FDA is showing better stabilization - perhaps working to pave the way for a possible nomination.” This was another theme Crowley hit at BIO this week, telling attendees of an FDA Town Hall on Tuesday that he’s sensed the agency is “getting the house in order” under the direction of its temporary leaders.
Other potential candidates for FDA commissioner featured on RBC’s candidate list include Stephen Ferrara, the principal deputy assistant secretary of war for health affairs; Norman Sharpless, professor of cancer policy and innovation at the University of North Carolina School of Medicine; and Richard Pops, chairman and CEO of neuroscience-focused biotech Alkermes.
RBC does not, however, expect a near-term change. “Our May 28 consultant feedback indicated Diamantas is likely to stay through midterms and could serve the full 210-day acting period through early December,” the analysts wrote.
