Trump's FDA pick is surgeon and writer Martin Makary

By Michael Erman

(Reuters) - U.S. president-elect Donald Trump has nominated surgeon and writer Martin Makary to lead the U.S. Food and Drug Administration, the world's most influential drug regulator with a more than $7 billion budget.

The FDA regulates human and veterinary drugs, medical devices and vaccines, approving new treatments and assuring 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.

Makary is a physician at Johns Hopkins Hospital in Baltimore whose most recent book, Blind Spots: When Medicine Gets It Wrong and What It Means for Our Health, was published in September. In interviews promoting the book, he spoke out against what he called "massive overtreatment" in the U.S. - "an epidemic of inappropriate care."

In a statement announcing his pick on Friday, Trump said Makary was needed "to course-correct and refocus the Agency."

Trump added he was confident Makary would "cut the bureaucratic red tape at the Agency to make sure Americans get the Medical Cures and Treatments they deserve."

He raised concerns about a number of public health issues during the COVID-19 pandemic in the Wall Street Journal, touting the protection received from natural immunity and opposing COVID vaccine mandates for the general public.

He 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.

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 advisor to Washington conservative healthcare think tank Paragon Health Institute.

Makary would succeed Dr. Robert Califf, a cardiologist and researcher who had previously 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.

(This story has been refiled to add dropped period and quotation mark in paragraph 5)

(Reporting by Michael Erman; Editing by Daniel Wallis)