Marty Makary Was the Worst FDA Commissioner in 25 Years

Marty Makary resigned as the Commissioner of the Food and Drug Administration on May 12, 2026, following a tenure marked by significant internal and external criticism.

Reporting from STAT indicates that Makary’s departure comes amid assessments that his leadership was detrimental to the agency’s operational health and regulatory standards.

Matthew Herper, who has covered the FDA for 25 years, provided a stark evaluation of Makary’s time in office.

I have covered the FDA for the past 25 years, and so I don’t say this lightly: Marty Makary was the worst commissioner in that time.

STAT

According to the report, Makary assumed the role with a fundamental lack of understanding regarding the nature of the commissioner’s position, the core functions of the FDA, and the specific needs of the agency’s workforce.

This disconnect reportedly manifested in a failure to maintain the agency’s leadership structure. The reporting notes that Makary allowed too many senior officials to be removed or to leave the agency during his tenure.

the analysis suggests that Makary weakened regulatory standards and ignored the guidance of staff members who possessed expertise in both the scientific data and the political art of regulation.

As his tenure progressed, Makary reportedly became increasingly isolated. He was described as being obsessed with notching “wins” that often lacked meaningful impact or substance.

Despite these critical assessments of his management and regulatory approach, some of Makary’s policy initiatives were viewed as strong ideas.

Among these were efforts to foster the integration of artificial intelligence within the process of drug development.

Makary also sought to accelerate the pace of clinical trials and improve the efficiency of the drug review process.

A key component of this efficiency drive was the attempt to reduce dead time, referring to the periods when pharmaceutical companies wait for responses from agency reviewers.