STAT+: Why Marty Makary was the worst FDA commissioner in 25 years

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. Makary, who resigned under pressure from the Food and Drug Administration on Tuesday, brought to the job a fundamental lack of understanding of the nature of the role, of the functions of his agency, and of the needs of the employees who worked for him. He allowed too much of the senior leadership of the agency to leave or be removed, weakened its standards, and ignored staffers who understood both the science and the political art of regulation. Toward the end of his tenure, he seemed isolated and obsessed with notching “wins” that often amounted to very little. That is not to say he did no good at all: Makary’s efforts to foster the use of artificial intelligence in drug development, to speed the drug review process by reducing dead time as companies wait for responses from reviewers, and to accelerate clinical trials were all strong ideas.Continue to STAT+ to read the full story…