President-elect Donald Trump has selected Dr. Martin Makary to lead the Food and Drug Administration. Makary is a surgeon from Johns Hopkins who has been fairly outspoken regarding the Agency that oversees our drug and food supply.
He appears to be critical of some of the Agency’s decision-making processes and it looks like he will insert himself into the job that the FDA does and how it does it. We have previously posted (here) about the potential tension between members of the new administration and the Agency, but at least now we know who will be heading the FDA and we’ll just have to wait and see how he shapes Agency policies and practices as well as what changes may come in regard to the Agency’s communications with its stakeholders. But from what we have read, he will certainly challenge the FDA and will likely put significant effort into assuring that scientific decisions are based on the best data available and well vetted.
Will he be anything like former FDA commissioner Scott Gottlieb, M.D. or more like current commissioner Robert Califf, M.D.? They had different styles of management but both were extremely effective in running the Agency and had a penchant for the science behind Agency decisions.
With the new administration’s public pronouncements thus far about the need to shake up the FDA and its “cozy” relationship with industry, it will be interesting to see how the new FDA boss will play out his hand once he takes charge. From what I have heard from former FDA colleagues, they are very anxious to see where the cards will fall, to know whether to hold ‘em or fold ‘em.
