The widely covered impending ouster of FDA Commissioner Marty Makary not long after the exit of controversial biologics head Vinay Prasad highlights the severe turnover rates at the highest rungs of leadership at the health department.
The reported termination of FDA Commissioner Marty Makary could come as a double-edged sword for biopharma, experts say. On one hand, new agency leadership could restore some degree of predictability and trustworthiness to the regulator; on the other, Makary’s potential departure—swiftly following the exit of the agency’s biologics head—adds to the high-level hemorrhage of leaders at the Department of Health and Human Services.
President Donald Trump has reportedly agreed to a plan to let go of Makary, The Wall Street Journal reported Friday afternoon, citing anonymous sources with knowledge of the matter. The news comes just a week after Vinay Prasad, the similarly controversial ex-director of the Center for Biologics Evaluation and Research (CBER), left the agency.
While Trump has disavowed the reports of Makary’s ouster—saying that he knows “nothing about it,” according to reporting from Fox News on Saturday—industry watchers are already speculating about the potential consequences.
If it does happen, Makary’s exit “is likely a broad positive for BioPharma,” according BMO Capital Markets.
“Throughout Makary’s time as FDA Commissioner, some investors have felt a sense of inconsistency in how specific company drug applications have been handled,” BMO analysts told investors in a note on Friday. “Makary’s tenure has been anchored in trying to provide more transparency, but controversial decisions and inconsistency have mired this perception.”
In particular, the group pointed to the second rejection for Replimune’s viral oncolytic drug RP1—a decision that has kicked up a firestorm of criticism against the FDA, enough that Makary himself had to address the blowback publicly.
“If Makary is ultimately removed, we would view this as a broad positive for the sector, potentially bringing more consistency to messaging, incentivizing further investment,” BMO noted. There has been no potential replacement named yet, but FDA Deputy Commissioner Kyle Diamantas is a top candidate, according to a May 8 report from Reuters, which cited three anonymous sources. Diamantas is the agency’s top food executive.
Still, the analysts cautioned that Makary’s exit won’t immediately mean a reversal of fortune for Replimune. “Don’t get your hopes up, just right now,” BMO wrote. “We do not expect [Makary’s removal] meaningfully changes RP1’s second denial,” the group said on Friday, noting that the rejection letter spelled out issues with the application “that would likely require a new trial to resolve.” Nevertheless, Replimune shot up 22% by the close of Friday’s trading session.
Like Prasad’s exit, Makary’s reported removal opens up the possibility of a more consistent, less controversial FDA. However, it also reinforces the widespread instability at the highest levels of the regulator. Prasad himself briefly departed the agency after just a few months on the job in the midst of a spat with Sarepta Therapeutics last summer. Then, his permanent exit was announced in March, although Makary claimed the plan was always for Prasad only to serve at FDA for a year.
CBER is now under the stewardship of Katherine Szarama—but only temporarily. Szarama, who was Prasad’s deputy, is reportedly not on the shortlist to head the CBER permanently.
The Center for Drugs Evaluation and Research (CDER) has also seen high levels of leadership turnover. The current head, Tracy Beth Høeg, is the fourth person under the second Trump administration to lead the unit, following Jacqueline Corrigan-Curay, George Tidmarsh and Richard Pazdur. Like Szarama, Høeg is only the division’s acting director and has yet to be replaced by someone who will take the job permanently.
