Now that Dr. Marty Makary, MD, MPH, has been confirmed and appointed as FDA Commissioner, much of the Agency does not look the same. The morale at the FDA, from what I hear, is at an all-time low. And now, with reports of the reduction in workers’ safeguards along with actions as to what appears to be removing much of the Union’s influence in enforcing those safeguards, one must wonder whether it will get better anytime soon. And just thinking about the firings and layoffs, retirements, and buyouts of potentially thousands of FDA staff, Dr. Makary, who, at his confirmation hearings said that he wanted to revisit staffing moves and layoffs, it is clear that he may need to act immediately. It is unfortunate timing (in my opinion) that he was not yet named commissioner when the initial firings occurred.
Speaking to some of my contacts who are still currently at the FDA, the hardworking employees there are very nervous. Imagine trying to hire at the Agency under the current circumstances? Facing a possible HR person telling you, “Well, we’d like to hire you today and have you start tomorrow, but we don’t know how long we can keep you,” which may not portray the most employee-friendly environment.
Look, I’m not sticking my head in the sand and saying that there are not some federal workers (as there are in all systems) that use the worker protections they are afforded to milk the system, but from my experience at the Agency most are hardworking, dedicated employees. Concentrate on fixing the problem of culling out poor performers, but when I hear that maybe 10,000 workers in HHS will be let go from the Department, it leads me to wonder if the firings strive to achieve a number only and are not reflective of removing the lower performing workers. When I was at the FDA, it was very unusual for me to leave the office after an eight-hour shift; most days it was 10-12 hours and don’t forget Saturdays, Sundays, or holidays…and I was certainly not an exception to the rule.
With the upcoming user fee negotiations of the major UFAs, the situation may be very bleak. As Derrick Gingery from the Pink Sheet noted in his story published March 27, 2025, “Giuseppe Randazzo, senior VP of sciences and regulatory affairs at the Association for Accessible Medicines, said he expected staffing to be discussed but was unsure ‘how the current climate will impact those negotiations.’ Randazzo said AAM is looking at potential incremental improvements to the GDUFA program, along with ‘bigger ideas.’” As an example, it has taken almost 14 years since the first Generic Drug User Fee Program was implemented and the review and approval process is moving along well. Could it be more efficient? Yes, but in my view, can it stand to lose a significant number of its staff without significant damage to the progress that has already been made? No!
Anyway, we will see how Dr. Makary’s first few months in charge of the FDA goes as we fully support his efforts to assure availability and safe medicines for the American public. Will he be able to keep what most of us on the outside see as a potential for slowdown in the FDA’s review and approval process of drugs, biologics, biosimilars, devices, as well as maintain an adequate inspectorate to protect the health and safety of the drug supply? I think the month of April will be very telling.
