On March 1, 2025, former NIH director Francis Collins’ announced that he had fully resigned from the NIH, where he continued to lead a laboratory after his resignation as director. Collins gave no reason for his resignation, but it comes just before this week’s confirmation hearings for Jay Bhattacharya, who is U.S. President Donald Trump’s nominee to lead the NIH and who Collins called a “fringe epidemiologist” during the COVID pandemic. It is a bitter irony that when Collins resigned as NIH director in 2021, then-President Joe Biden said that “countless researchers will aspire to follow in his footsteps.”
Martin Makary, President Donald Trump’s pick to head the U.S. FDA, took his turn before the Senate Health, Education, Labor and Pensions (HELP) Committee March 6, a week ahead of the committee’s confirmation votes on both him and Jay Bhattacharya as the next NIH director. The committee votes will set the stage for the full Senate to vote on confirming both nominees later this month.
Jay Bhattacharya will have his work cut out for him if he wins confirmation as the next director of the U.S. NIH. Besides getting NIH committees back on track to evaluate grant applications and calming the fears of researchers and other staff who have seen about 1,200 colleagues cut from their ranks in recent weeks, Bhattacharya will face the task of rebuilding public trust in the NIH itself.
The executive orders (EOs) pouring out of the Trump White House, and the resulting court challenges, continue to pile up, deepening the uncertainty hanging over the life sciences sector and the U.S. economy in general.
On March 1, 2025, former NIH director Francis Collins’ announced that he had fully resigned from the NIH, where he continued to lead a laboratory after his resignation as director. Collins gave no reason for his resignation, but it comes just before this week’s confirmation hearings for Jay Bhattacharya, who is U.S. President Donald Trump’s nominee to lead the NIH and who Collins called a “fringe epidemiologist” during the COVID pandemic. It is a bitter irony that when Collins resigned as NIH director in 2021, then-President Joe Biden said that “countless researchers will aspire to follow in his footsteps.”
The rash of firings at agencies of the Department of Health and Human Services has provoked a Feb. 28 letter from Reps. Dianna DeGette (D-Colo.) and Frank Pallone (D-N.J.), blasting the dismissals and insinuating that the dismissals were politically motivated.
Nick Decker, directory of global regulatory policy for Roch Holding AG’s Roche Diagnostics division, said the FDA is moving carefully into the PCCP space, and industry, too, is taking a measured approach in adopting the PCCP concept.
A number of regulatory agencies have signed on to the Medical Device Single Audit Program (MDSAP) for postmarket uses, but the U.S, FDA cannot use these audits for premarket purposes.
The U.S. Congress is turning its attention, once again, to bipartisan pharmacy benefit manager (PBM) reforms, after efforts to rein in PBM practices died with the 118th Congress. With an eye on finally getting them passed, the House Energy and Commerce Committee kicked off the process with a Feb. 26 hearing that was supposed to be focused on the reform legislation the committee approved last year and follow-on legislation to rein in harmful PBM practices.
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.
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