By Michael Erman
(Reuters) -U.S. president-elect Donald Trump has nominated surgeon and writer Martin Makary to lead the Food and Drug Administration, the world’s most influential drug regulator with a more than $7 billion budget.
Makary, a physician at Johns Hopkins Hospital in Baltimore, where he is chief of islet transplant surgery, in interviews promoting his most recent book spoke out against what he called “massive overtreatment” in the U.S. – “an epidemic of inappropriate care.” The book, “Blind Spots: When Medicine Gets It Wrong and What It Means for Our Health,” was published in September.
In a statement announcing his pick on Friday, Trump said Makary was needed “to course-correct and refocus the Agency.”
The FDA regulates human and veterinary drugs, medical devices and vaccines, and approves new treatments and assures they are safe and effective before they enter the biggest and most lucrative healthcare market in the world. The agency is also responsible for safety standards for food, tobacco and cosmetics.
Trump said he was confident Makary would “cut the bureaucratic red tape at the Agency to make sure Americans get the Medical (TASE:) Cures and Treatments they deserve.”
Makary had raised concerns about a number of public health issues during the COVID-19 pandemic in essays published in the Wall Street Journal, touting the protection received from natural immunity and opposing COVID vaccine mandates for the general public, though he was not opposed to the vaccines.
Makary would report to Trump’s pick to lead the Department of Health and Human Services, Robert F. Kennedy Jr., if he is confirmed by the Senate. Kennedy, an environmental lawyer and activist who has spread misinformation on vaccines, has vowed to work to end chronic disease, clean up corruption and provide Americans with the data they need to make informed decisions about their health.
RBC analyst Brian Abrahams said in a research note earlier this week that Makary was likely to be more industry unfriendly than his predecessor.
“Dr. Makary could make the agency more suspicious of, rather than collaborative with, drugmakers, with his criticisms around medication overuse potentially leading to a more skeptical and less permissive culture around approving drugs with mixed data or more modest benefits,” Abrahams wrote.
As a doctor, Makary was a co-developer of the Surgery Checklist, a routine for surgeons that improved surgical outcomes and has been spread around the globe by the World Health Organization.
He has advocated for reexamining the use of hormone replacement treatment in menopausal women, reducing overuse of antibiotics and reforms to medical education.
Makary, who lives in Baltimore, has also served as an adviser to Washington conservative healthcare think tank Paragon Health Institute.
Makary would succeed Dr. Robert Califf, a cardiologist and researcher who had held the role of FDA commissioner in the Obama administration. In his second term under President Joe Biden, Califf revamped the agency’s food operations and inspections processes and tried to combat misinformation.
