Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
In late March, I was shocked to come back from a family vacation to learn that Peter Marks was stepping down as director of the FDA’s Center for Biologics Evaluation and Research. Little did we know, that was just the beginning.
Marks’ departure, together with this week’s shocker—Richard Pazdur’s retirement just three weeks into his new role as director of CBER’s sister department, the Center for Drug Evaluation and Research—bookend a year of rapid fire and often drama-filled turnover in the most senior ranks of the FDA. When Pazdur leaves, just three names from the agency’s senior organizational chart from a year ago will remain standing.
The U.S. biopharma industry has been shrouded in uncertainty this year, from drug pricing reform to tariffs to the long-term shortage of capital. Amid this backdrop, the continued instability of the leadership at the country’s drug regulator is an unforced error we can’t afford.
After news of Marks’ resignation broke, BIO President John Crowley issued a statement imploring the retention of scientific expertise and strong leadership. On Tuesday afternoon, in response to Pazdur’s move toward retirement, he didn’t hold back.
“Dr. Pazdur’s departure raises serious concerns about the repeated turnover in key leadership occurring at the FDA,” Crowley wrote in a prepared statement. “This constant turmoil is undermining America’s leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China.”
A Mountain of Institutional Knowledge Lost
A well-respected regulator in a world of novel modalities, Marks had pledged to work with the incoming administration despite ideological differences and a massive workforce reduction. But it seems a lack of trust ultimately forced him out.
Marks apparently refused to grant editing access for the Vaccines Adverse Event Reporting System (VAERS) to the team of Health Secretary Robert F. Kennedy Jr. for fear that “they’d write over it or erase the whole database,” according to the Associated Press. He was then given the choice to resign or be fired.
In his resignation letter, Marks wrote that he had been hoping to work with Kennedy and address his “concerns regarding vaccine safety.” But that collaboration was not in the cards.
“It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote.
Marks’ ousting was what first prompted us here at BioSpace to take a closer look at the turnover of FDA’s leadership. At that time, in early April, more than half the roles in FDA’s senior organizational chart, which includes the Office of the Commissioner and FDA HQ offices, had turned over since the election the previous November.
Since then, there have been several more surprise exits—not to mention the astonishing return of Marks’ replacement, Vinay Prasad, after a short hiatus following the Sarepta drama this summer.
Some of these leaders have gone out quietly. Yashika Rahaman, who reported to the FDA commissioner as director of the Office of Planning, Evaluation, and Risk Management for the last five years of her 17-year tenure at the agency and was director of the FDA Enterprise Risk Management Program before that, noted her July departure from the agency on LinkedIn but it did not make the news.
Others, of course, have made countless headlines, in BioSpace and other industry brands as well as national newspapers. George Tidmarsh, who resigned as CDER director at the beginning of November but said he would fight to clear his name, is a prime example. He stepped down as an investigation into his personal conduct was getting underway. In a now-deleted LinkedIn post, Tidmarsh questioned the market approval of Aurinia Pharmaceuticals’ lupus nephritis drug Lupkynis. Kevin Tang, chair of Aurinia’s board of directors and well-known in the industry for buying up struggling biotechs through Concentra Biosciences, filed a complaint.
And if we thought that was fit for TV, Pazdur’s sudden retirement is the twist we maybe should have predicted. He reportedly declined the CDER role when it was first offered to him but FDA Commissioner Marty Makary fought for him and he ultimately agreed—and the industry breathed a sigh of relief.
But ultimately Pazdur, an FDA veteran of nearly three decades, plans to walk away from it all—director of CDER and his former role as director of the Oncology Center of Excellence, a department he founded in 2017. And he’s apparently doing so over concerns about how the FDA is conducting itself.
RBC Capital Markets described Pazdur’s departure succinctly. “[It] rekindles regulatory uncertainty as record FDA leadership turnover continues,” the analysts wrote in a Tuesday afternoon note to investors. “[It’s] a significant, sudden and surprising turn.”
Clearly, the FDA soap opera has not yet concluded. Could Makary be the next episode?
The Wall Street Journal reported last month that Kennedy was considering limiting Makary’s role or bringing on someone else to run the agency, even if Makary stayed on as a figurehead. Just before Thanksgiving, the White House denied a promotion for Makary’s aide.
RBC analysts certainly didn’t dismiss the idea. “Given Dr. Pazdur’s departure, and the multiple high-ranking officials that have left, even if temporarily, in our view it would not be unreasonable should Dr. Makary’s tenure be on shaky ground,” they wrote.
And what would that mean for biopharma companies navigating this unstable and uncertain regulatory environment? Unfortunately, they may just have to stay tuned to find out—a wait-and-see game that puts the industry under immense strain.
Crowley expressed the desperation of the situation. “We are at a tipping point,” he wrote. “It is time to right this ship.”
