Peter Marks’ March 28 letter giving one week’s notice of his resignation as director of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) is sending more ripples of uncertainty throughout the industry. Marks, who has helmed CBER for nearly a decade, blamed his departure on recently confirmed Health and Human Services (HHS) Secretary Robert Kennedy, who has made a career out of his anti-vaccine stance.
The Trump administration dashed hopes that it would temper the Medicare price negotiations mandated by the Inflation Reduction Act when it filed the government’s brief in response to Novartis AG’s appeal to the U.S. Court of Appeals for the Third Circuit.
Citing recent executive orders that suggest additional cuts to the federal workforce may be in the offing, U.S. Sens. Patty Murray, D-Wash., and Jeanne Shaheen, D-N.H., wrote to Health and Human Services Secretary Robert Kennedy urging him to end “indiscriminate cuts that will cause lasting harm to FDA’s public health mission” and to protect the agency’s statutory obligations.
As the flurry of executive orders continues to flow from the White House, leaving in its wake chaos and confusion across the overall health care sector, Tim Opler, managing director of the global health care group at investment firm Stifel, is taking the long view and urging the biopharma sector to continue focusing on innovation.
With massive terminations, data removals, holds on U.S. government funding, cancellation of various programs and meetings, the potential for 25% tariffs on medical products and a multitude of court challenges and appeals, the dust is flying thick at the FDA, NIH and throughout the Department of Health and Human Services (HHS).
As part of a U.S. government-wide reduction in force aimed at restructuring and streamlining federal agencies, 5,200 Health and Human Services employees reportedly received their pink slips over the weekend, with 1,165, or 22%, of those at the NIH.
Coming as no surprise, the U.S. Senate’s Feb. 13 confirmation of Robert Kennedy as the next secretary of the Department of Health and Human Services (HHS) did nothing to ease the uncertainty hanging over the FDA and other HHS agencies.
The immediate implementation of the U.S. NIH’s guidance to cut indirect costs included in its grants to 15% was quickly halted late Feb. 10 when a federal district judge granted a nationwide temporary restraining order in two separate challenges to the cuts that were to go into effect that day on all existing and new NIH grants.
Carrying out his campaign promises to reform government, President Donald Trump signed 46 executive orders (EOs) between Jan. 20-31 that have been published in the Federal Register. Of those, 26 were signed after noon and between all the inaugural events on Trump’s first day in office. Since then, he’s signed at least eight more orders, and the administration has issued numerous memos, several of which are intended to implement the EOs. Given the quantity, scope and content of the EOs Trump has issued over the past few weeks, it’s no surprise that they’ve generated controversy, a lot of uncertainty and at least a few court challenges.
