The reinstatement of the generic drug policy office is the latest reversal of course for Robert F. Kennedy Jr.'s HHS, which also recently rehired FDA staff responsible for making travel arrangements and those involved in user fee program negotiations.
The FDA has brought back its generic drug policy office after previously gutting the team, according to a Monday report from Endpoints News, marking the latest development in the Trump administration’s back-and-forth staffing measures.
It remains unclear why the FDA decided to reinstall the generic drug policy team, or how many of its former members will return, Endpoints reported, citing two FDA sources with knowledge of the matter who requested anonymity. One source told the publication, however, that some fired staffers had already reported to the FDA’s Maryland campus on Monday.
The FDA had disbanded its generic policy office in April—a move that former Commissioner Scott Gottlieb, in an opinion piece for STAT News, said “eliminated precisely the kind of government spending that delivered the most bang for the taxpayers’ buck.” This mass dismissal, he added, “could stall the arrival of affordable generic alternatives to some of today’s most expensive medications.”
This is not the first time the administration has laid off employees en masse before changing course. In mid-February, shortly after his inauguration, President Donald Trump terminated hundreds of employees across the FDA, a move that gutted several key centers within the agency, including those responsible for regulating medical devices, food and tobacco products. Just a week later, however, Reuters reported that the FDA was planning to rehire some 300 of these laid-off staff.
In late March, Health and Human Services Secretary Robert F. Kennedy Jr. announced a massive reorganization of the HHS, including putting some 10,000 jobs on the chopping block. The FDA was set to suffer the heaviest blow, with 3,500 roles at risk. The agency has since brought back dozens of these employees after running into several regulatory delays. Staff responsible for making travel arrangements for inspectors and those involved in the user fee program negotiations have returned.
Also on Monday, a group of current and former NIH staffers issued the Bethesda Declaration, decrying the agency’s mass cancellation of thousands of research grants amounting to $9.5 billion as well as $2.6 billion in terminated contracts. The declaration also called out the administration’s politicization of research topics like health disparities, COVID-19 and immunization as well as gender identity and sexual health.
Beyond staffing and budget cuts, the Trump administration’s health policies have weighed heavily on biopharma, including proposed tariffs on drug imports, sweeping changes to vaccine regulation, the appointment of polarizing agency leaders and drug pricing policy that will have far-reaching implications for the sector.
