Biopharma leaders cautiously welcome Trump FDA pick

With a new commissioner of the US Food and Drug Administration in the line of sight, biopharmaceutical executives and analysts are feeling cautiously optimistic, but many are still concerned about Robert F. Kennedy Jr. and other health-care-related cabinet picks.

President-elect Donald J. Trump announced Friday evening that he would nominate Marty Makary to lead the FDA. Makary is a surgeon at the Johns Hopkins Hospital who rose to prominence for his work on surgical checklists and has authored books advocating hospital reform.

Also on Friday, Trump named Janette Nesheiwat, a doctor who contributed to Operation Warp Speed, the federal initiative to develop COVID-19 vaccines, to the position of surgeon general and Dave Weldon, another doctor and a former congressman, to lead the Centers for Disease Control and Prevention (CDC).

Like Kennedy, who would be his boss if confirmed to lead the Department of Health and Human Services (HHS), Weldon has raised alarm bells among health advocates: both have promoted the debunked notion that vaccines cause autism. While in Congress, Weldon also introduced legislation that would have moved vaccine safety research out of the CDC and into another HHS office.

A biotechnology executive and investor, who requested anonymity in order to preserve relationships with regulators, describes Makary as a “reasonable choice.”

“Someone we as an industry can work productively with,” the person says by email. “Not specific to biotech, but I am more concerned about Dave Weldon for CDC from a public health perspective given his support for discredited autism/vaccine misinformation.”

Biopharma executives and investors appear to agree on Makary. Biotech stocks were generally up in the first few minutes of trading Monday morning following Friday’s announcements.

“I think Marty Makary is generally an acceptable choice given his background, credentials, and public statements,” says another biotech executive, who requested anonymity in order to speak freely about the incoming administration. “I look forward to a rigorous Senate confirmation process to understand his candidacy better.”

Makary has recently made a public name for himself by criticizing the medical establishment. In September he published Blind Spots, a book making the case that most American doctors engage in “groupthink” instead of basing their practices on science. For instance, Makary writes in the book that although the American Academy of Pediatrics’ 2000 recommendation that infants avoid peanuts ended up correlating with a rise in peanut allergies in the US, many doctors still tell parents to wait until their children are toddlers before allowing them to try peanuts. Scott Gottlieb, who served as FDA commissioner during Trump’s first term, recommended the book “highly” in a post on X.

Makary has also been critical of COVID-19 vaccine mandates and pandemic-driven school closures. He championed the “herd immunity” approach to managing the virus early on. Infectious disease experts have said that with rapidly changing viruses like SARS-CoV-2, there’s effectively no such thing as herd immunity, and natural immunity tends to wane quickly.

Makary has decried what he perceives as the tendency of US doctors to overprescribe medications rather than address the cause of illness. He has zeroed in on antibiotics as a prime example, since their unnecessary use damages the gut microbiome and leads to opportunistic infections like Clostridioides difficile and to antimicrobial resistance.

He’s also called for a focus on “food as medicine,” an interest he shares with current FDA commissioner Robert Califf, who has worked to reform the agency’s food branch during his tenure.

“The country is getting sicker. We cannot keep going down this path,” Makary said during a roundtable convened by Sen. Ron Johnson (R-Wis.) in September. “We have the most overmedicated, sickest population in the world, and no one is talking about the root causes.”