With the FDA now rudderless following the revelation that Commissioner Marty Makary, M.D., is stepping down, voices across biopharma have joined in supporting the FDA’s former top drug regulator, Richard Pazdur, M.D., as President Donald Trump’s next logical pick to lead the agency.
But despite the vote of confidence in a letter to Trump signed by more than 300 industry leaders—including pharma and biotech CEOs, VC firm partners and patient advocacy group directors—it remains unclear whether Pazdur would want the job. Last month, he told Fierce that another administration would need to occupy the White House before he might consider returning to the FDA.
The letter was sent by a coalition of industry leaders and the advocacy group No Patient Left Behind.
The regulator currently needs a leader like Pazdur, given that “[d]ecisional volatility, staff exodus, missed deadlines, and eroding scientific predictability at the FDA have created a crisis of confidence in America’s ability to remain a leader in biomedical progress,” the letter to the President reads.
In a broad call for stability at the agency, the letter stressed the importance of scientific credibility and independence, consistency and predictability, and relying on proven institutional leadership at the FDA.
Pazdur—who retired from the agency last December after a brief stint as head of the FDA’s Center for Drug Evaluation and Research (CDER)—established a reputation for “credibility, rigor, and results” over his 26-year tenure, the leaders continued.
The letter authors also emphasized Pazdur’s hand in founding the FDA’s Oncology Center of Excellence, praising the division he built for its ability to assess “each disease on its own biological terms rather than applying a one-size-fits-all framework.” Such an approach “is precisely the framework that can be applied across all disease states,” the authors added.
Even if Pazdur is not selected—or does not choose—to assume the top spot at the FDA, the qualities laid out should apply to any choice made by the administration, the letter concludes.
"We are endorsing the qualities that any FDA leader must possess: deep regulatory experience, a track record of reform, and the ability to lead a scientific institution under political and competitive pressure without compromising regulatory independence, speed or rigor," Priscilla VanderVeer, executive director of No Patient Left Behind, said in an emailed statement.
The desire among certain industry members for a stable, well-respected leader like Pazdur is understandable, given the tumult that has engulfed the FDA and other federal health agencies under the second Trump administration. Still, Pazdur has been critical of how the FDA has operated lately, and he indicated last month that his potential return under a Trump presidency is a remote possibility.
When Fierce Biotech polled Pazdur on the sidelines of the annual AACR meeting in San Diego in April on whether he’d been asked to return to the FDA since leaving or would ever consider doing so, Pazdur clarified, “not under this administration,” adding that the rationale behind that stance should be “obvious.”
Fierce has reached out to Pazdur for comment on the letter.
At the time Fierce spoke to Pazdur last month, the regulatory veteran—speaking at an industry partnering event during the AACR conference—drew attention to “an attack on the federal workforce” over the past year, referring to massive reductions in force that took place at the FDA last April.
Pazdur also pointed to the agency’s apparent icing out of career staff on certain public-facing decisions and messaging, plus infrequent gatherings of advisory committees to wade through complex scientific questions and the potential pitfalls of the controversial Commissioner’s National Priority Voucher (CNPV) program. The initiative, rolled out under Makary, could allow undue influence to color agency decisions, Pazdur and others have warned.
Reports first surfaced late last week that President Trump had signed off on a plan to fire Makary, who has taken flak from varied groups around FDA decisions on products like the abortion pill mifepristone and fruit-flavored vapes, while also confronting criticism of potential political influence seeping into the regulator’s actions.
By Tuesday, Politico had reported that Makary was resigning, citing an anonymous administration official. While official FDA materials online have not yet reflected the change, Makary’s departure has been widely reported, and President Trump seemed to confirm the move when speaking to reporters earlier this week, calling Makary a “great guy” who was “going to be off.”
Trump also seemed to confirm reports that Kyle Diamantas, the FDA deputy commissioner for food, would temporarily lead the agency in an acting capacity, and admitted that Makary had been “having some difficulty,” according to a report from The Hill.
While Makary had come into the crosshairs of several factions, including pro-life groups, lawmakers and even certain members of the industry weary from leadership turnover and brain drain at the FDA, it was ultimately HHS Secretary Robert F. Kennedy Jr. who pushed for his removal, according to Politico, again citing an unnamed administration official.
That alleged revelation follows other recent reports that Makary had been clashing with Kennedy, as well as HHS chief counselor and director of Medicare Chris Klomp.
Prior to Makary’s departure, Vinay Prasad, M.D., who had a tumultuous, on-again-off-again stint as the director of the Center for Biologics Evaluation and Research, left the agency for the second time at the end of last month, with his deputy, Katherine Szarama, Ph.D., taking over on an acting basis.