Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces.
First it was individuals: multiple rounds of job cuts at the FDA only for some of those staffers to be hired back. Now it’s groups of FDA employees getting the bait-and-switch en masse. As the Department of Government Efficiency (DOGE) began cutting leases on federal sites, 30 FDA facilities appeared to be facing closure. But at at least one facility, FDA officials reportedly told scientists of such a fate on Monday, but by Wednesday they said, essentially, never mind.
The sweeping changes—and lack of transparency surrounding them—unfold just as President Donald Trump’s healthcare administration is solidifying. Vocal vaccine skeptic Robert F. Kennedy Jr. has been at the helm of the Department of Health and Human Services (HHS) for three weeks now, and this week, Jay Bhattacharya, Trump’s pick to lead the National Institutes of Health (NIH) and FDA Commissioner nominee Marty Makary faced Congress in confirmation hearings.
Makary evaded questions from the Senate Health, Education, Labor, and Pensions (HELP) Committee about a vaccine advisory panel meeting that was canceled and would not commit to reinstating it. In fact, Makary said he would “reevaluate which topics deserve a convening of the advisory committee members [on the vaccine panel] and which may not require a convening,” according to Biopharma Dive.
Senators also asked Bhattacharya about his history of criticizing COVID-19-related lockdowns and mandatory vaccination policies. While Bhattacharya said in response to a question from Senator Bill Cassidy (R-LA) that he does not “generally believe that there is a link” between vaccines and autism, he said he is open to supporting more studies on the topic, CNN reported.
Next up is Trump’s nominee to lead the Centers for Disease Control and Prevention, David Weldon, who will face the HELP Committee next Thursday and potentially be asked about a postponed CDC vaccine advisory committee.
Despite the uncertainty, most industry analysts have remained largely neutral on the new cast of Trump’s ongoing reality TV presidency, with Jefferies saying they have “more bark than bite.”
And when it comes to FDA turnover that wasn’t driven by the new president, the analyst firm speculated about a slight positive effect for the industry. Specifically, the former head of the FDA’s Center for Drug Evaluation and Research (CDER), Patrizia Cavazzoni, recently stepped down from her post, and companies who spoke with Jefferies “all say things have been on track, no notable changes or delays, and in some cases the new CDER leadership is even more on board for accelerated filings and more pro-rare disease acceleration than prior CDER oversight,” the firm wrote in a note to investors this week.
Tariffs: Here Today, Gone Tomorrow
On a broader sociopolitical scale, the Trump administration has played a similar bait-and-switch game with tariffs. On Tuesday, Trump implemented his long-promised 25% tariffs on goods from Canada and Mexico. Just two days later, most of those tariffs were paused until April 2.
Biopharma companies are also facing tariff pressure after the president told leaders of the largest companies in a private meeting last month that they could face tariffs if they fail to relocate their manufacturing operations to the U.S. Eli Lilly responded just days later, announcing plans to invest $27 billion to ramp up its U.S. manufacturing capacity, this week calling for bids to take a piece of that investment. Pfizer CEO Albert Bourla, meanwhile, said his company is prepared to shift its manufacturing operations to the U.S. should the need arise.
Of course, if recent history is any guide, pharma companies probably shouldn’t expend too much energy shifting course on manufacturing. Like they say in many places down south, if you don’t like the weather (in this case, political winds)—wait five minutes.
