Trump’s FDA pick Overton good for psychedelics, new pain meds but bad for vaccines: analysts

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If confirmed by the Senate, Heidi Overton—officially revealed Wednesday as President Donald Trump’s choice for FDA commissioner—is expected to be a boon for developers of psychedelic therapeutics and non-opioid pain drugs, but could tow the party line on vaccines.

It’s official. President Donald Trump will nominate Heidi Overton as the next FDA commissioner. Trump announced the news himself on his Truth Social platform early Wednesday afternoon.

In the post, which refers to Overton as “Dr. Heidi,” Trump called the current White House policy advisor a smart and respected “ROCKSTAR” who would “rapidly” deliver on his priorities of faster cures, innovation, lower drug prices and more wins for Health Secretary Robert F. Kennedy Jr.’s Make America Healthy Again (MAHA) movement. “We need her leadership at the FDA now to ensure that the U.S. remains the WORLD LEADER for Scientific Discovery and CURES,” Trump continued in the post.

Analysts reacting to reports of Overton’s nomination on Wednesday appear to agree that the Trump administration isn’t looking to rock an already unsteady boat. The general physician, if approved by the Senate, could provide strong support for the administration’s psychedelics and non-opioid pain medicine initiatives—while possibly kowtowing to would-be boss Robert F. Kennedy Jr. on vaccines.

Overton, who currently serves as the deputy assistant to the president for domestic policy, was reportedly involved in the drafting of an executive order (EO) to accelerate the development of and facilitate broader access to psychedelic therapies.

“Her visible role in the April 2026 executive order prioritizing FDA review of ibogaine and MDMA-based therapies, highlights the administration’s approach to use of psychedelics as medicine,” BMO Capital Markets wrote in a note to investors on Wednesday.

Truist Securities in a Tuesday evening note also pointed to Overton’s role in the EO. “She has drawn MAHA attention for the inter-agency process she ran on the psychedelics/ibogaine EO,” the analysts wrote.

The agency’s finalized recommendations for clinical testing of psychedelic compounds for mental health could pave the way for companies like Compass Pathways, whose psilocybin-based therapy for treatment-resistant depression could win approval as early as this year.

Overton is also likely to support continued progress in the non-opioid pain arena. Since the January 2025 approval of Vertex Pharmaceuticals’ Journavx as the first new mechanism for acute pain in two decades, drug development in the space has taken off. Most recently, AbbVie ventured into the field with an up to $715 million deal with China’s Haisco Pharmaceutical Group in April. Overton’s nomination could be a boon for Vertex, AbbVie and several other companies committed to offering alternatives to the controversial pain drugs at the root of the opioid epidemic.

“Journavx momentum should continue under Overton,” BMO wrote on Wednesday, additionally noting that “her 2017-2018 opioid prescribing work” with former FDA Commissioner Marty Makary “lines up with the non-opioid pain agenda behind Vertex’s Journavx approval.” Overton and Makary penned a peer-reviewed paper titled “Overprescribing is major contributor to opioid crisis,” in October 2017.

Overton’s support for non-opioid options should be “an incremental positive as VRTX pushes into broader indications,” BMO said.

In one hot-button drug development space, however, analysts appear wary of Overton’s influence.

“Vaccine makers shouldn’t expect a friendlier FDA, given Overton’s involvement in this year’s executive orders reshaping the childhood vaccine schedule,” BMO wrote, “keeping potential regulatory risk alive for Merck, Pfizer, and BioNTech.”

Melanoma was slower to recur in patients receiving Merck and Moderna’s mRNA vaccine with Keytruda, supporting use of the combination in adjuvant treatment. The partners plan to take the data to the FDA.

Indeed, Overton was in attendance last week when Trump signed an executive order recommending that the measles, mumps and rubella (MMR) vaccine should be split into three separate shots. During the press conference announcing the EO, the president falsely suggested the number or timing of vaccines could play a role in rising rates of autism spectrum disorder, per the Associated Press.

Regulatory expert Steven Grossman expressed reservations about Overton’s nomination. “I am concerned about: her lack of management experience, her apparent willingness to undercut vaccines, and—especially given her close White House ties—her understanding of science-based decisionmaking,” said Grossman, president of policy and regulatory consulting firm HPS Group, prior to Trump’s announcement.

Truist was more positive. “Our sense is that Dr. Overton could drive healthy debate internally, though ultimately cede to the administration, which is what we & investors ultimately may want from the seat from our conversations,” the analysts wrote on Tuesday. “[She is] science-driven though diplomatic to the administration, which to us could strike the perfect balance.”

Moreover, Truist added, “She also appears as the more conventional, pharma-friendly profile on evidence standards.”

Despite his concerns, Grossman encouraged an open mind to Trump’s FDA pick. “Nonetheless, stakeholders should hear her out before locking in their position.”

If confirmed, Overton would be the first woman since 2015—and just the third woman ever—to lead the FDA.

Heather McKenzie is senior editor at BioSpace. You can reach her at heather.mckenzie@biospace.com. Also follow her on LinkedIn.
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