President-elect Donald Trump nominated Dr. Marty Makary will lead the Food and Drug Administration on Friday and select a surgeon and author to oppose it vaccine mandates and some other public health measures during the coronavirus pandemic.
Makary, a professor at Johns Hopkins University, is the latest in a series of Trump nominees who have declared that the US health care system is “broken” and in need of overhaul.
Photo by Noam Galai/Getty Images for HBO
Makary has criticized the overprescribing of drugs, the use of pesticides on food, and the outsized influence of pharmaceutical and insurance companies over doctors and government agencies in books and articles.
“I’m part of a generation that says, ‘We as a medical generation have made some mistakes, we’ve done things that have resulted in a loss of public trust and we need to be open and honest about our problems as we go fixing it,” Markey said in a 2012 interview with “CBS Mornings.”
Trump announced the nomination in a statement Friday evening, saying Makary would “restore the FDA to the gold standard of scientific research, and cut red tape at the agency to ensure Americans receive the medical treatments and treatments they need.” they deserve.” Makary will need to be confirmed by the Republican-led Senate.
Headquartered in suburban Maryland outside Washington, the FDA’s 18,000 employees are responsible for the safety and effectiveness of prescription drugs, vaccines and medical devices, as well as a range of other consumer goods, including food, cosmetics and vaping products . In total, these products represent an estimated 20% of US consumer spending per year, or $2.6 trillion.
Makary rose to prominence on Fox News and other conservative media for his contrarian views during the COVID-19 pandemic. He questioned the need for masking and while not opposed to the COVID-19 vaccine, Makary raised concerns about vaccinations in young children.
The Centers for Disease Control and Prevention estimates that COVID-19 vaccinations prevented more than 686,000 deaths in the U.S. in 2020 and 2021 alone. While children suffered much lower hospitalizations and deaths from the virus, medical associations including the American Academy of Pediatrics concluded that vaccinations significantly reduced serious illness in this age group.
Makary, trained as a surgeon and cancer specialist, was part of a vocal group of doctors who called for greater emphasis on herd immunity to stop the virus, or for the idea that mass infections would quickly lead to population-level protection.
In a February 2021 Wall Street Journal article, he wrote that “COVID will be largely gone by April, allowing Americans to resume normal life.” That summer, the delta variant of the virus swept through the US, followed by omicron in the winter, causing hundreds of thousands of additional deaths.
If Makary is confirmed and anti-vaccine activist Robert F. Kennedy Jr. It is also confirmed that Trump has made the choice 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 harbors a similar distrust of the pharmaceutical industry.
Makary has lamented that drug makers have used misleading data to encourage doctors to prescribe OxyContin and other opioids as low-risk, non-addictive painkillers. That marketing was allowed under FDA-approved labeling from the 1990s, which indicated the drugs were safe for common ailments such as back pain.
In more recent years, the FDA has come under fire for approving drugs for Alzheimer’s disease, ALS and other conditions based on incomplete data that failed to demonstrate meaningful benefits to patients.
A push for more oversight of drug safety and effectiveness would mark a major shift at the FDA, which has focused on speeding drug approvals for decades. This trend has been fueled by industry lobbying and fees paid by drug manufacturers to help the FDA recruit additional reviewers.
Kennedy has proposed ending these payments, which would require billions in new funding from the federal budget.
Other policy priorities would likely encounter similar roadblocks. For example, Kennedy wants to ban drug makers from advertising on TV, a billion-dollar market that supports many TV and cable networks. The Supreme Court and other conservative justices 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 launched 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 case of other controversial initiatives under Trump, career staffers may simply delay work until a new administration comes into power.
“The bureaucracy can wait on anyone, and I think you’ll hear that attitude a lot,” said Wayne Pines, a former FDA official under Republican and Democratic administrations.
