FDA in chaos following departure of long-time cancer researcher

The Food and Drug Administration is experiencing renewed scrutiny as Commissioner Marty Makary faces questions from Trump-era officials amid ongoing instability within the agency. Several prominent resignations have sparked concern over Makarys leadership, according to sources familiar with internal discussions.

The most notable departure is that of Dr. Richard Pazdur, a longtime researcher who shaped the FDAs cancer treatment strategy. Pazdur is set to retire this month, only weeks after agreeing to lead the FDAs largest division responsible for prescription medications, over-the-counter drugs, and essential pharmacy products. His exit comes amidst ongoing disputes with FDA leadership over departmental control and balancing accelerated drug approvals with rigorous quality oversight.

Insiders report that tensions escalated when Makary urged Pazdur to replace career regulators with politically appointed hires. While Makary has been closely allied with Health and Human Services Secretary Robert F. Kennedy Jr., Kennedy has expressed frustration with the agencys public controversies following a meeting with Pazdur.

Pazdurs resignation has raised widespread concern within both the administration and the pharmaceutical sector about potential disruptions to the drug review process and possible erosion of confidence in the FDA, often considered a global benchmark for drug and vaccine regulation. Under Kennedys leadership, numerous career officials have been dismissed, leading to significant policy shifts, including adjustments to childhood vaccine recommendations.

Despite internal frustrations over the FDA departures, some of Kennedys appointees addressed the turmoil with levity at a meeting concerning the universal hepatitis B vaccination for newborns. Dr. Tracy Beth Hoeg, Pazdurs successor, joked about the lack of dramatic events during her presentation on changes in the FDAs vaccine review procedures. Subsequently, CDC advisors voted to discontinue hepatitis B vaccinations for newborns.

Makary met with White House officials following Pazdurs announcement, adding urgency to an already scheduled discussion. Spokespeople for both the White House and HHS emphasized that Makary remains fully supported in his role, praising the agencys ongoing initiatives and announcements.

Pazdurs departure is the latest in a series of high-profile FDA exits this year. Vaccine chief Peter Marks left in March after clashing with Kennedy, and Vinay Prasad, a previous critic of the FDA, temporarily departed amid political pressures before returning. Earlier conflicts between Prasad and top drug regulator George Tidmarsh also contributed to internal upheaval, with Tidmarsh resigning abruptly under controversy.

Makary faced additional scrutiny after a close adviser prematurely presented herself as his deputy chief of staff. While the White House concluded the situation was a misunderstanding, the incident highlighted ongoing tensions within agency leadership.

Pazdur initially declined the role of FDA drug director but accepted after a personal meeting with Makary. Despite his willingness to serve, he quickly became frustrated with political interference and questioned whether expedited drug review processes could maintain safety standards. A recent memo from Prasad proposing new vaccine approval procedures further fueled concern about potential disruptions to the regulatory framework.

During his meeting with Kennedy, Pazdur expressed worries that the current leadership was undermining the drug review system. Some officials downplayed the significance of his departure, framing it as the exit of a dissatisfied career employee rather than a critical turning point for the administrations agenda.

Observers note that Pazdurs resignation, while sudden, was not unexpected. One former official commented that such a departure was anticipated, though the speed of his exit took some by surprise.

Author: Benjamin Carter