Commissioner Makary Vows to End Big Pharma Conflicts of Interest at the FDA

In a candid interview with Megyn Kelly on Thursday, the new Food and Drug Administration Commissioner, Dr. Marty Makary, announced he will limit the ability for FDA decision makers to benefit from the companies they are responsible for regulating.

Kelly kicked off her interview with Makary with a revelatory clip from the 2023 Netflix series “Painkiller,” a fictional, six-part limited series, about the birth of the opioid crisis and the culpability of the Saxler family that owned Purdue Pharma, the creator of OxyContin. (The series stars Matthew Broderick as Richard Sackler.)

The clip reveals how common it is for FDA employees to get cozy with the very companies they are tasked to regulate. Referring to Curtis Wright (played by series creator Noah Harpster), the FDA medical review officer who approved OxyContin's use in the late 90s and went on to work for Purdue, the character investigating the collusion asks, “Do you think there is quid pro quo with Purdue?” The response: “Well, I get that it has the appearance of corruption, but it’s possible there wasn’t. What Curtis Wright did is the way the industry works. It’s a revolving door where as soon as people leave the government, they go and work for the exact people they were regulating for five times the money and it’s all legal.”

Wright isn’t the only officer at the FDA who went on to a cush job with the company over which they were the purported watchdog. Scott Gotleib, MD, the head of the FDA during President Trump’s first term, is now a member of Pfizer’s board of directors. Patrizia Cavazzoni, MD, worked for Pfizer both before and after her tenure at the FDA, where she served as the agency's top drug regulator as director of the Center for Drug Evaluation and Research.

“Today we are announcing that we are removing industry members – pharma members – from FDA advisory committees,” Makary told Kelly during her interview. “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.”

While Makary didn’t directly address the issue of former FDA employees working for pharma companies after public service, he believes the move to end the ability for pharma representatives to sit on the panels that approve drugs will greatly reduce conflicts of interest and ensure better safety regulations for pharmaceuticals.

“There should not be a cozy relationship – there should be a user-friendly process for industry, but not a cozy relationship,” Makary said.

Makary emphasized that he doesn’t want to shut out pharmaceutical companies, but that the approval process needs to be completely independent of their influence.

“A lot of people in the United States feel that the system is rigged,” Makary told Kelly. “[The FDA] is an agency that belongs to the American people and so we can work with pharma and at the same time ensure that scientific evaluation processes are totally independent.”

When Kelly pressed him on the issue of former FDA regulators jetting off after their time at the FDA to work in high-level positions within big pharma, Makary responded, “I don’t know. We live in a free country. I do know some of these individuals and they are good people and they’re all God’s children, they’re doing what the market incentivizes.”

He said the agency did consider an ethics pledge but that it would be non-binding once an employee returns to the private sector.

But Makary reiterated what the FDA can do. “We can create a culture here where people want to stay,” he said. “We can ensure that people who leave don’t have undue influence.”

Makary also revealed how many lobbyists, former members of Congress, and what he called “the swamp,” approached him once he got nominated, offering to help his confirmation process by writing letters to senators on his approval committee. To which Makary responded, “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 than have those obligations.”

Makary was one of the only Trump nominees to have a handful of Democrat senators vote for his confirmation along with unanimous Republican support. The final vote was 56-44 in favor.

Makary emphasized that his job should be one of the least political of all federal positions. “We’re talking about values,” Makary stated. “There’s literally nothing political about looking at the influence of food colors and ingredients and evaluating the GRAS standard and getting infant formula without seed oil and added sugar and rewriting our nutrition guidelines, which we’re doing right now. These are the most apolitical things in society.”

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