In an opinion piece in USA Today (here), eight career executives at the FDA, Patrizia Cavazzoni, Acting Director of the Center for Drug Evaluation and Research, Peter Marks, Director of the Center for Biologics Evaluation and Research, Susan Mayne, Director of the Center for Food Safety and Applied Nutrition, Judy McMeekin, Associate Commissioner for Regulatory Affairs, Jeff Shuren, Director of the Center for Devices and Radiological Health, Steven Solomon, Director of the Center for Veterinary Medicine, Janet Woodcock, Director or the Center for Drug Evaluation and Research (on detail to the Office of the Commissioner), and Mitch Zeller, Director of the Center for Tobacco Products, expressed their view on the FDA’s science-based decision-making process and how they are reached.
The article notes that there are 17,000 career FDA staff that are dedicated to the protection of the public’s health. We have read a lot about the political challenges facing the FDA and understand that even a health‑based Agency is not without political influence, especially in the current administration, as well as in the face of a national health emergency, but it is reassuring (and as a former career FDA official and former Acting Deputy Director of the Office of Generic Drugs, I would expect nothing less of the Agency) to hear the top brass provide this assurance that science alone will dictate their decisions. Even with the caveat at the end of the article that says, “The co-authors of this column are the senior career executives at FDA who oversee all the work of the agency’s centers and field operations. The views expressed here are exclusively their own and do not represent the position of the FDA, the Department of Health and Human Services or the U.S. government,” we should have confidence not only in their motives but also be well aware that they will make the right science-based decisions, despite any criticism that is leveled from outside of the Agency.
I firmly believe that when the rubber meets the road, the FDA will have our backs! And you should too!