Despite these cuts, the FDA should be able to stay above a “trigger” level that would prevent it from collecting fees from the pharma industry and deprive it of approximately half of its annual funding, according to The Washington Post.
The Trump administration is lining up a $40 billion cut to the Department of Health and Human Services, shrinking the agency’s budget by around a third, according to a report from The Washington Post on Wednesday.
Citing leaked internal documents, the Post noted that the steep cuts will lower the National Institutes of Health’s budget by approximately 40% to $27 billion, down from $47 billion last year, while the Centers for Disease Control and Prevention will be left with $5.2 billion, down from $9.2 billion—a 44% reduction. Rural programs would be hit especially hard by the cuts, while the Head Start program, which offers childcare services for low-income families, would be terminated altogether.
The FDA’s cuts will not drop it below the minimum threshold that would prevent it from collecting user fees from the pharma industry, according to the Post, which has seen the preliminary budget.
Earlier this month, policy expert Alexander Gaffney warned that the FDA could be rushing toward a “catastrophic collapse” if continued cuts at the agency triggered a certain mechanism of the Prescription Drug User Fee program, which in turn could deprive the regulator of around half of its annual budget.
Alongside these cuts, the new HHS budget accounts for the creation of a new HHS agency, according to the Post. The Administration for a Healthy America (AHA), which will advance Secretary Robert F. Kennedy Jr’s pet initiative to “Make America Healthy Again,” and will get $20 billion.
Many consolidated agencies, including those working in primary care and HIV, will be folded into the AHA, as per the Post, and will have an explicit focus on childhood chronic conditions.
Wednesday’s preliminary budget leak follows what has been a massive upheaval at the HHS in recent weeks. Last month, shortly after his confirmation, Kennedy unveiled plans to lay off some 10,000 employees at the Department, saying at the time that “bureaucracies like HHS become wasteful and inefficient.” Another 10,000 staffers had already voluntarily left the Department since the start of the year.
Perhaps most relevant to the biopharma industry, the FDA has likewise lost thousands of employees since Kennedy took leadership of the HHS, including several senior leaders. Most notable of these exits is that of Peter Marks, former head of the Center for Biologics Evaluation and Research. While at the FDA, Marks earned a reputation for being an advocate of vaccines and regulatory flexibility.
Last week, during a scheduled tour at the FDA, Kennedy berated the agency’s staff, accusing them of being a “sock puppet” to the pharma industry.
