The Make America Healthy Again (MAHA) movement proved to be more than just a campaign talking point for Donald Trump. Robert F. Kennedy Jr. is now heading up the Department of Health and Human Services (HHS), and Marty Makary, MD, was tapped to lead the Food and Drug Administration (FDA).
Dr. Makary breezed through the Senate confirmation process (even getting the support of a few Democrats along the way), and has now been at the FDA for 17 days. His time thus far has been spent listening and learning to get a better sense of the state of the agency and what needs to be done to restore the public trust that eroded during the COVID pandemic.
On Thursday’s show, Megyn traveled to FDA headquarters to sit down with Dr. Makary for his first interview as commissioner and learn more about steps he is already taking to limit conflicts of interest with Big Pharma.
Becoming Commissioner
Dr. Makary was a highly respected surgical oncologist at Johns Hopkins and health policy expert, who emerged as a leading voice of reason during COVID. He said he “had a lot of emotions” leaving the operating room for the final time before his confirmation hearings began and is now adjusting to the “entirely different world” he finds himself in.
What interested him in the job, however, was the opportunity to address the public health problems in the U.S. today. “We are not on a good path as a country in terms of the health outcomes,” Dr. Makary explained. “We do great with sophisticated operations and amazing drugs that can treat certain kinds of lymphoma and other types of cures, but when it comes to the health of the population right now we have had this massive… rise of all these chronic diseases.”
He believes the country needs to “start talking about our problems” rather than “just keep throwing medications at them,” and that requires a blend of established orthodoxy and new thinking. “We need the old guard to ensure that we hold to rigorous scientific methodology, and we need fresh, new ideas at the same time,” he said. “We’re trying to bring all of that together now.”
The Revolving Door
With that said, Dr. Makary acknowledged that many Americans have lost faith in public health entities like the FDA. Part of that has to do with the fact that there often appears to be a revolving door between these agencies and major pharmaceutical companies.
The movie Dopesick and other projects about the opioid crisis often reference Curtis Wright, the medical review officer who approved OxyContin while at the FDA and then went on to work for the drug’s maker Purdue Pharma.
More recently, Patrizia Cavazzoni, MD, left Pfizer in 2018 to work for the FDA where she became the agency’s top drug regulator as director of the Center for Drug Evaluation and Research. In January, she departed the FDA and Pfizer announced weeks later that it hired Cavazzoni to replace its outgoing chief medical officer.
Additionally, Scott Gottlieb, MD, who was FDA commissioner from 2017 through 2019 during the first Trump administration, is a member of Pfizer’s board of directors. And the list goes on from there.
“Let’s be honest, a lot of people in the United States feel that the system is rigged. A lot of people feel that the relationship is too cozy between pharma and regulators,” Dr. Makary admitted. “This is an agency that belongs to the American people, so we can work with pharma and, at the same time, ensure that the scientific evaluation process is totally independent.”
Limiting Conflicts
That is why one of his first acts as FDA commissioner is aimed at limiting conflicts of interest. “Today we are announcing that we are removing industry members – pharma members – from FDA advisory committees,” Dr. Makary shared. “I was shocked when I learned that employees of Big Pharma companies sit on FDA advisory committees as members of those committees, so we’re going to be replacing them, whenever statutorily possible, with patients and family caregivers.”
He said the dynamic between the pharmaceutical industry and government needs to change. “We have to partner with industry and pharma to facilitate the process to make it user-friendly and expeditious… We want American pharma companies to do well and companies that do business in the United States to do well,” he added. “But the scientific evaluation needs to be independent.”
“The pharma and device members on those advisory committees will say that they are ‘non-voting members,’ but there is a sort of a close club of individuals that has a running dialogue… [and] we need the scientific evaluation and the voting to be totally independent,” he continued. “People ask, ‘Are you anti-pharma or pro-pharma? And the reality is, we are pro-pharma but our evaluation has to be independent and we cannot have any more indications for chronic pain written for a drug based on a 14-day study where the regulator then goes immediately works for the company.”
As Dr. Makary explained, that is “the kind of thing that breeds distrust” and is “why people perceive that this agency, the FDA, has been captured by industry.”
Draining ‘The Swamp’
As it relates to senior leaders ferrying back and forth between government and drug manufacturers, Makary said the FDA needs a culture change because the country should not “tolerate” the behavior. “We cannot have people who leave as regulators go to the industry, and we’ve thought about an ethics pledge. We’ve thought about all kinds of things,” he said. “It’s non-binding because we live in a free country… but what we can do is create a culture here where people want to stay. We can ensure that people who leave don’t have undue influence.”
The “influence” piece is something he has already experienced firsthand. “When I got this nomination for the job, I cannot tell you how many lobbyists, former members of congress, ‘the swamp’ reached out to me,” Dr. Makary recalled. “I mean, I was in the operating room and the next day I discovered what the swamp was.”
He said the overtures came in the form of things like “we want to help you with your confirmation,” or “we want to write a letter on behalf of our company to the senators on your committee,” or “we know these senators, we’re going to talk to them if it’s okay with you.”
Dr. Makary said he turned them all down. “You know what I said: Don’t talk to the senators. I don’t want your letters. They’re not for free. Those are obligations that then you feel indebted to return once you’re in office, and I’d rather not get confirmed into this job and have those obligations,” he shared.
An Apolitical FDA
Dr. Makary is currently on “a listening tour” at the FDA to speak with the career scientists and various departments that he said have become “siloed” with their own “communications [team], and lawyers, and lobbyists for Congress, and IT departments” that do not talk to one another.
In many ways, this set up gets back to the ‘culture’ issue. “We are trying to make sure they have all the resources they need to do their job well,” Dr. Makary said. “And we are trying to change the culture here… to a culture of teamwork, the scientific gold standard, and common sense.”
If agencies like the FDA are to learn anything from the MAHA movement, he said, it is that public health is nonpartisan. “There should be nothing political about the FDA. We’re talking about values,” Dr. Makary said. “Republican, Democrat, and independent moms came out and voted for President Trump and they believed in Secretary Kennedy’s MAHA mission.”
“There is literally nothing political about looking at the influence of food colors and ingredients, and evaluating the grass standard, and getting infant formula without seed oil and added sugar, and rewriting our nutrition guidelines, which we’re doing right now,” he concluded. “These are the most apolitical things in society.”
You can check out Megyn’s full interview with Dr. Makary by tuning in to episode 1,051 on YouTube, Apple Podcasts, or wherever you like to listen. And don’t forget that you can catch The Megyn Kelly Show live on SiriusXM’s Triumph (channel 111) weekdays from 12pm to 2pm ET.