FDA in Upheaval as Staff Layoffs Begin
HHS began laying off FDA employees 4/1, with many receiving email notifications in the early morning hours or being denied entrance at security checkpoints at the agency’s White Oak, MD campus. The terminations are part of the plans HHS announced last week (see earlier story) that estimated FDA will lose about 3,500 (18%) of its 19,000 full-time employees under restructuring ordered by the president’s Department of Government Efficiency (DOGE) Workforce Optimization Initiative.
The latest departures involve high-level and lower-level positions. Most notably, CDER Office of New Drugs (OND) director Peter Stein told HealthCare Dive he is leaving the agency after declining a “silly alternative job” in patient affairs he was offered instead. “Many folks within OND were affected,” said Stein, who added that planning for the layoffs did not involve CDER or OND leadership. “I know the loss of many support and review functions across OND that are critical to the work we do is going to have a deep impact on our efficiency and our capabilities.”
Center for Tobacco Products (CTP) director Brian King was also let go, in addition to dozens of other CTP employees who were responsible for drafting new tobacco regulations and setting policy, according to the Associated Press (AP). The agency’s entire press office was given notice too. Senior officials who help oversee new drug reviews and vaccines were also let go, according to FDA staffers who spoke to the AP on condition of anonymity.
“The FDA as we’ve known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed,” former FDA commissioner Robert Califf wrote in a 4/1 LinkedIn post Tuesday. “I believe that history will see this a huge mistake ... It will be interesting to hear from the new leadership how they plan to put ‘Humpty Dumpty’ back together again.”
Former FDA commissioner (2017-2019) Scott Gottlieb posted on X that he feared this “cumulative barrage” against FDA could lead to a resurgence of a U.S. drug lag, where Europeans would see medical advances years before Americans. There has been a “generation of congressional actions, investments in expertise and hiring, and careful policymaking” that built FDA into the “most efficient, forward-leaning drug regulatory agency in the world — and established the U.S. as the global center of biopharmaceutical innovation,” he said. But this could all be lost from what is being allowed to happen to the agency, which will particularly affect products for rare diseases and areas of significant unmet medical need, he added.
Meanwhile, new FDA commissioner Marty Makary has been publicly silent on the upheaval at his agency. He was quietly sworn in last week and as his first order of business, he signed off on the ouster of CBER director Peter Marks (see story), according to several media outlets. Marks’ two-page forced resignation letter noted that he had attempted to address HHS secretary Robert F. Kennedy Jr.’s concerns regarding vaccine safety and transparency but “it has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies.”