Ozempic? Robert F. Kennedy Jr. is not a fan.
“If we just gave good food, three meals a day, to every man, woman and child in our country, we could solve the obesity and diabetes epidemic overnight,” he said to Greg Gutfeld on Fox News before the election. He added that the drug’s maker, Novo Nordisk, is “counting on selling it to Americans because we are so stupid and so addicted to drugs.”
His opinions might remain just that — opinions. But now that President-elect Donald J. Trump has said he will nominate Mr. Kennedy to lead the federal Department of Health and Human Services, he may gain powers to turn some of his opinions into federal policies.
Mr. Kennedy has not said he will limit access to Ozempic or other drugs. He did not reply to requests for comment about what he may do as secretary of health and human services.
Here is a look at what powers he would have in that role.
Can a health secretary reverse a drug’s approval?
The short answer is no.
The Food and Drug Administration is part of the Health and Human Services Department, but the secretary does not directly approve drugs. Any attempt to withdraw the approval of the obesity drugs would have to be initiated by the F.D.A.
Holly Fernandez Lynch, an associate professor of law at the University of Pennsylvania who specializes in F.D.A. drug approval standards, explained what it would take.
The grounds for withdrawal, she said, include compelling evidence that a drug is not safe or effective. Drugs can also be withdrawn if a company submitted “untruths in the application materials,” she said, or did not provide adequate records or make required reports. Another reason, she added, is “manufacturing concerns,” which might include contamination of the drug or inconsistency in its formulation.
Are there grounds for revoking approval of Ozempic and other weight-loss drugs?
The F.D.A. has granted approval so far to four new drugs that have been shown to cause weight loss: Ozempic, for diabetes and to reduce the risk of complications from heart disease, and Wegovy, for obesity and heart disease, both made by Novo Nordisk; and Mounjaro, for diabetes, and Zepbound, for obesity, both made by Eli Lilly. Others are in late-stage clinical testing.
When it comes to issues that might drive the F.D.A. to withdraw approval, “none of those apply to the GLP-1’s,” Ms. Lynch said, referring to the new obesity drugs. “Full stop.”
Craig Garthwaite, an economist at Northwestern University, said he could not see a path for withdrawal of the drugs: “There is nothing about the approval of these drugs that opens the door for the F.D.A. to do anything.”
Like all drugs, they have risks, which are listed on their labels. Ozempic’s label mentions, for example, pancreatitis and complications of diabetic retinopathy. One concern that emerged after the drug was approved, that it increased suicidal ideation, did not hold up after further studies by the F.D.A. and European drug regulators.
Yet Ms. Lynch, who is scheduled to give a paid speech to Eli Lilly on F.D.A. drug approval standards, said that even if there was no legal basis to withdraw these drugs, a federal administrator could still try.
What would happen if a secretary tried to withdraw a drug anyway?
The result would be lawsuits.
“Then it would be up to a judge to decide,” Ms. Lynch said. “And we know we have some federal judges who are perfectly happy to second-guess the F.D.A.’s approval decisions,” she added.
But Laurie Beyranevand, a professor at Vermont Law and Graduate School, had a different take: Given the requirement to show the drugs are not safe or not effective, combined with their popularity, their market share and, as she put it, “the interested stakeholders” who would challenge a withdrawal attempt, she doubts that such an effort would succeed.
Does the secretary have other powers that could limit drugs like Ozempic?
Even if the obesity drugs are not withdrawn from the market, their use could be limited. That’s because Medicare or Medicaid pays for the drugs for millions of Americans, and both programs are part of the department Mr. Kennedy would lead.
Over 72 million Americans are enrolled in Medicaid. An additional 53 million get drugs through Medicare.
Medicare covers Ozempic and Mounjaro for diabetes and Wegovy for obesity and heart disease. Beneficiaries choose from a list of commercial insurers who provide prescription drugs. Medicare subsidizes those payments under a program called Part D. Different companies have different lists of covered drugs. Rachel Sachs, a law professor at Washington University in St. Louis who advised H.H.S. officials in 2023 and 2024, noted that Medicare is prohibited from interfering when insurance companies participating in Part D choose which drugs to cover.
Mr. Trump has also said he will nominate Dr. Mehmet Oz to head the Centers for Medicare and Medicaid Services, known as C.M.S., under Mr. Kennedy. Ms. Sachs said she would expect litigation if Dr. Oz tried to prevent Part D companies from including Ozempic in their coverage.
Medicaid is different. It is administered through the states.
Donald Taylor, a public policy professor at Duke University, explained that Medicaid could be barred from paying for Ozempic and similar drugs through a lengthy process to create new regulations, or if Congress passed a law prohibiting such payments and Mr. Trump signed it. That would mean that C.M.S. would not help pay for the drugs and states would have to decide whether to pay for the drugs themselves.
But having Congress micromanage which drugs Medicaid pays for “does not sound like the most conservative health policy idea ever,” Dr. Taylor said.
He added, though, that anyone who says they know what will happen to health policy in the second Trump administration “is not being honest with themselves.”
Could Kennedy promote changes to Americans’ diets as health secretary?
Mr. Kennedy has said the solution to obesity and other health problems is to give everyone “good food.”
Dr. Frank Sacks, emeritus professor of cardiovascular disease prevention and medicine at Harvard, tested that idea in a study that compared four healthy diets in 811 overweight adults.
After two years, participants had lost a bit more than six pounds on average and had slightly lower cholesterol levels. Insulin levels improved slightly with three of the four diets. While a few people lost significant amounts of weight — as much as 50 pounds — and kept it off for the two years of the study, nearly all of the rest remained overweight.
Asked in an email whether a healthy diet would cure obesity, Dr. Sacks replied, “No diet does that!”
But even if Mr. Kennedy tries to promote healthy foods, it is the U.S. Department of Agriculture, not the Department of Health and Human Services, that is most involved in what foods Americans eat.
