President-elect Donald Trump nominated Dr. Marty Makary Friday to lead the Food and Drug Administration, selecting a surgeon and author who opposed vaccine mandates and some other public health measures during the coronavirus pandemic.
Makary, a Johns Hopkins University professor, is the latest in a string of Trump nominees who have declared the U.S. health system to be “broken” and in need of a shakeup.
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Makary has criticized in books and articles the overprescribing of drugs, the use of pesticides on foods and the undue influence of pharmaceutical and insurance companies over doctors and government regulators.
Trump announced the nomination in a statement Friday night, saying Makary would “restore FDA to the gold standard of scientific research, and cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve.” Makary will have to be confirmed by the Republican-led Senate.
Headquartered in the Maryland suburbs outside Washington, the 18,000 employees of the FDA are responsible for the safety and effectiveness of prescription drugs, vaccines and medical devices as well as a swath of other consumer goods, including food, cosmetics and vaping products. Altogether those products represent an estimated 20% of U.S. consumer spending annually, or $2.6 trillion.
Makary gained prominence on Fox News and other conservative outlets for his contrarian views during the COVID-19 pandemic. He questioned the need for masking and, though he was not opposed to the COVID-19 vaccine, Makary had concerns about vaccinations in young children.
The Centers for Disease Control and Prevention estimated that COVID-19 vaccinations prevented more than 686,000 U.S. deaths in 2020 and 2021 alone. While children faced much lower rates of hospitalization and death from the virus, medical societies including the American Academy of Pediatrics concluded that vaccinations significantly reduced severe disease in the age group.
Trained as a surgeon and cancer specialist, Makary was part of a vocal group of physicians calling for greater emphasis on herd immunity to stop the virus, or the idea that mass infections would quickly lead to population-level protection.
In a February 2021 Wall Street Journal piece, he wrote that “COVID will be mostly gone by April, allowing Americans to resume normal life.” That summer the delta variant of the virus ripped through the U.S., followed by omicron in the winter, leading to hundreds of thousands of additional deaths.
If Makary is confirmed and anti-vaccine activist Robert F. Kennedy Jr. is also confirmed as Trump’s pick to oversee the Department of Health and Human Services, which includes the FDA, Makary would likely report to Kennedy. Makary does not share Kennedy’s discredited views on vaccines, but he has a similar distrust of the pharmaceutical industry.
Makary has lamented that drugmakers used misleading data to urge doctors to prescribe OxyContin and other opioids as low-risk, non-addictive pain relievers. That marketing was permitted under FDA-approved labeling from the 1990s, suggesting the drugs were safe for common ailments like back pain.
In more recent years, the FDA has come under fire for approving drugs for Alzheimer’s, ALS and other conditions based on incomplete data that failed to show meaningful benefits for patients.
A push toward greater scrutiny of drug safety and effectiveness would be a major reversal at FDA, which for decades has focused on speedier drug approvals. That trend has been fueled by industry lobbying and fees paid by drugmakers to help the FDA hire additional reviewers.
Kennedy has proposed ending those payments, which would require billions in new funding from the federal budget.
Other administration priorities would likely run into similar roadblocks. For instance, Kennedy wants to bar drugmakers from advertising on TV, a multibillion-dollar market that supports many TV and cable networks. The Supreme Court and other conservative judges would likely overturn such a ban on First Amendment grounds that protect commercial speech, experts note.
Makary would also inherit a number of ongoing projects at the FDA kicked off by outgoing Commissioner Robert Califf, including the reorganization of the agency’s food division and plans to regulate artificial intelligence in medical technology.
In the event of other controversial initiatives under Trump, career staffers may simply drag the work out until a new administration comes to power.
“The bureaucracy can wait anybody out, and that’s an attitude I think you’ll hear a lot,” said Wayne Pines, a former FDA official under Republican and Democratic administrations.
