In a letter to President Donald Trump, a group of biotech executives recommended former cancer regulator Richard Pazdur to lead the agency after the departure of Marty Makary.
More than 100 biotech leaders have an idea for who should next lead the FDA: Richard Pazdur, the seasoned regulator who stepped down from the agency in December 2025 after 26 years of service.
In a letter to President Donald Trump, the biotech executives recommended Pazdur for the gig, days after Marty Makary resigned at the behest of the commander in chief and Health Secretary Robert F. Kennedy, Jr.
“Decisional 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, posted by the advocacy group No Patient Left Behind, reads. “Solving it requires leadership with proven experience, unimpeachable scientific credibility, and a demonstrated track record of leadership and effectiveness—all qualities Dr. Pazdur has demonstrated throughout his time at the agency.”
In the wake of Makary’s departure, analysts have said that the White House may have a hard time filling the role. A few potential names, such as former high-ranking FDA officials Brett Giroir and Stephen Hahn, have been floated but none have officially been named as of yet. The nominee will require a Senate confirmation, which could be a tricky proposition five months before the midterms.
Pazdur, on the other hand, is a shoo-in, according to the biotech executives. He stepped down from the FDA in December 2025, after briefly serving as head of the Center for Drug Evaluation and Research. Pazdur originally declined the role but was personally persuaded by Makary.
Prior to that, Pazdur served as director of the FDA’s Oncology Center of Excellence, an FDA division he founded and had led since 2017.
Since retiring from the agency, Pazdur has been outspoken about his concerns that politics were interfering in FDA operations, particularly for fast-tracked drug approvals. He also raised concerns about the abrupt layoffs at the agency and loss of veteran leaders.
The biotech executives say Pazdur has a track record of streamlining and speeding cancer drug approvals and is the best choice to lead the FDA after a period of turmoil. Several companies, including Capricor Therapeutics, uniQure and Replimune have experienced sudden reversals of guidance from the agency under Makary, resulting in drug approval delays.
“Investors and drug developers make decade-long bets based on their understanding of the regulatory pathway ahead,” the letter reads. “When standards shift mid-process or decisions seem disconnected from scientific evidence, capital and innovation disappear.”
Pazdur is the man to restore confidence, the group said.
“Dr. Pazdur’s appointment would send an unambiguous signal to global markets that America’s regulatory leadership is stronger than ever. He will stabilize new drug reviews, harmonize intra-agency practices, and restore the scientific engagement sponsors, patients, and scientists depend on.”
Signatories to the letter include the CEOs of ReCode Therapeutics, Ultragenyx, Synthekine, Tyra Biosciences and more; executives from investment firms Deerfield Management and RA Capital Management and members of No Patient Left Behind.
