Nyah Phengsitthy, Bloomberg Law, November 25, 2024
Marty Makary, an outspoken critic of the nation’s food and drug regulator, stands to shake up the FDA’s standards in science and decision-making under President-elect Donald Trump.
The Johns Hopkins surgeon selected Nov. 22 by Trump to lead the US Food and Drug Administration may have laid out his blueprint for a potential agency overhaul if confirmed as commissioner—and it starts with his criticisms over vaccine policy, food safety, and the pharmaceutical industry.
Makary has taken numerous shots at FDA decisions, including the agency’s approval of Covid-19 vaccines by Moderna Inc. and Pfizer Inc., its “cozy relationship” with drug manufacturers, and the approval of a drug to treat Alzheimer’s. He’s also offered judgment on the nation’s food supply, questioning the various chemicals in foods and infant formula.
While some of his opinions have drawn opposition, his critiques put to practice could reshape areas of the agency that have come under scrutiny, health policy experts say. His challenge on vaccine approvals, food safety, and the status quo ideas in the medical establishment signal a commissioner who won’t allow the agency to lower its standards and will tap more into science and decision-making.
“A lot of what he’s been talking about are things we need to be thinking about,” said Diana Zuckerman, president of the National Center for Health Research. “When you have somebody who’s outspoken on the side of public health, I think that’s something we should hear.”
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“Dr. Makary seems like a person who could be persuadable by an evidence-based argument,” said Peter Lurie, president of the Center for Science in the Public Interest and former associate commissioner for public health strategy and analysis at the FDA.
“But the most consistent through-line between the HHS, CDC, and FDA nominees seems to be being vaccine-skeptical or worse.”
‘Sticking to the Science’
Though it’s unclear how Makary’s concerns will play out as chief, he could demand the agency carry out deeper examinations and assessments in its everyday decisions.
The FDA in recent years has come under fire for some scientific conclusions and the information used to back its regulatory decisions. This includes its authority over e-cigarettes, the abortion pill mifepristone, laboratory-developed tests, and major drug approvals.
“You want to have that person very much sticking to the science, so that we know that these new medicines, medical devices, whatever comes to the market, is truly safe and effective,” said Reshma Ramachandran, an assistant professor at Yale School of Medicine.
“He has a pretty profound background in research, so that gives me some comfort knowing he will hopefully continue to follow the science in making decisions.”
Makary also “recognizes the value of not letting approval standards dip dangerously low,” said Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania. She pointed to when he criticized the FDA for approving Alzheimer’s drug aducanumab despite safety concerns.
The author and professor has taken issue with the lack of transparency between the agency and pharmaceutical industry. He’s also a critic of the Orphan Drug Act, which allows manufactures to secure protections for rare disease drugs when they hit the market.
“He wants to make sure that the agency’s decisions are being made from a scientific perspective, and not being unduly influenced by the sponsors who are bringing forward the products,” Ramachandran said. “I’m hoping he’ll maintain that thinking to make sure the agency is doing its due diligence in its work.”
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Food Safety
Makary’s agenda may test the FDA’s oversight on food safety—another area that has been scrutinized in recent years.
He has called the food supply “poisoned” with “highly addictive chemicals.” He’s also scrutinized the amount of seed oils in infant formula, and questioned why Froot Loops are sold with different food dyes in the US than in Canada.
His appointment would come as the FDA rolls out its Human Foods Program, which was created under the agency’s largest reorganization.
Notably, the program is in the midst of establishing a framework to assess chemicals in food already on the market—a move that was criticized for being conducted through an ad hoc basis and largely behind closed doors.
Makary could take “positive steps” in regulating and eliminating “harmful components that are still allowed in food, supplements, food containers and packaging,” according to Ana Santos Rutschman, professor at the Charles Widger School of Law at Villanova University.
“Among all the nominations so far in the public health space, this is the candidate with the strongest credentials,” Rutschman said. “And I think that there is, at least for now and in theory, room for some positive developments at the FDA.”
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