President-elect Donald Trump has put forward a formal pick for the top spot at the U.S. Food and Drug Administration.
As recently projected, Trump has named Johns Hopkins surgeon and author Martin Makary, M.D., as his choice for FDA commissioner during his upcoming term.
In a statement Friday, Trump said the FDA “has lost the trust of Americans” and needs Makary to “course-correct and refocus the Agency.”
Makary, who was born in Liverpool, England, before moving to Baltimore as a kid, is the current chief of islet transplant surgery at Johns Hopkins.
The nominee has previously critiqued the Orphan Drug Act pathway for rare disease treatments, accusing drugmakers of “gaming the system.” He’s also known as a vocal critic of vaccine mandates during the COVID-19 pandemic and has pushed back on the use of masks by children to reduce the spread of the virus.
News of Makary’s nomination follows two other major health endorsement by the president-elect.
In mid-November, Trump formally put forward Robert Francis Kennedy Jr. to serve as the next U.S. secretary of the Department of Health and Human Services. Just a few days later, the incoming commander-in-chief advanced television personality Mehmet Oz, M.D., also known as Dr. Oz, to run the Centers for Medicare & Medicaid Services.
RFK Jr. is a noted vaccine skeptic who has pledged to Make America Healthy Again, while Oz has faced criticism from the scientific community for his claims about dietary supplements and COVID-19 treatments. Oz previously served on Trump’s council on sports, fitness and nutrition in 2018.
In Friday’s statement, Trump said Makary will “work under the leadership of Robert F. Kennedy Jr. to, among other things, properly evaluate harmful chemicals poisoning our nation’s food supply and drugs and biologics being given to our nation’s youth, so that we can finally address the childhood chronic disease epidemic.”
If officially confirmed for the role of commissioner, Makary will succeed Robert Califf, M.D., who was nominated to lead the FDA by President Joe Biden in 2021 after serving in the same position, initially under President Barack Obama, from 2016 to 2017.
During a recent meeting of the Friends of Cancer Research, Califf expressed that he was “disappointed” by the outcome of the recent presidential election, using the opportunity to lay out his hopes for his successor.
He emphasized that the next FDA commissioner must have “the ability to listen to people with disparate points of view and take in and learn in a new environment. Califf also stressed that the appointee must believe wholeheartedly in the “critical role of high-quality evidence” and possess a “confidence that there is such a thing as expertise.”
Meanwhile, Makary’s nomination should help dispel some of the uncertainty around the effect of Trump’s second administration on the biopharma world, BMO Capital Markets analyst Evan David Seigerman wrote in a note to clients following the decision.
Seigerman said BMO was “most positive” on Makary for FDA Commissioner, a decision that coincided with nominations of Rep. Dave Weldon to lead the Centers for Disease Control and Prevention (CDC) and Janette Nesheiwat as the next U.S. Surgeon General.
“All in, we think the FDA pick should allow BioPharma investors a reprieve,” Seigerman wrote, noting that Trump’s choice “may reverse significant draw downs the week RFK Jr. was nominated head of HHS.”
He argued that Makary is likely to have a “more reasonable approach to running the FDA than has been feared,” adding that the nominee “appears well-versed across the continuum of U.S. healthcare and is supportive of evidence-based medical intervention.”
Editor’s note: This story was updated on Nov. 25 with analyst commentary.
https://www.fiercepharma.com/pharma/other-top-health-nominations-trickle-trump-names-pick-fda-commissioner
