Robert F. Kennedy Jr., chosen by President-elect Donald Trump to be the next health secretary, has made it his mission to dissipate what he describes as a “smothering cloud of corporate capture” within agencies like the Food and Drug Administration.
In particular, he aims to target perceived conflicts of interest among health officials, a goal seemingly shared by Trump’s choice to run the FDA, Johns Hopkins surgeon and medical researcher Marty Makary. But while Trump picked Makary to “course-correct and refocus” the agency, Makary will face scrutiny of his own background once Senate confirmation hearings get underway.
Concern around conflicts of interest at the FDA is nothing new. “Nine of the FDA’s past 10 commissioners went on to work for the drug industry or serve on the board of directors of a drug company,” according to a recent BMJ report. The agency is often criticized for being a revolving door, and ethics experts have questioned if close ties to the pharma industry create bias in public health decisions. Others argue that it’s difficult to find pharma experts who don’t have industry experience.
Employees at the FDA, including commissioners, are prohibited from holding financial interests, such as stock, in any of the companies the agency regulates. In the past, these conflicts have been disclosed to the Office of Government Ethics and brought during Senate hearings, with lawmakers questioning FDA nominees over stock holdings and industry positions.
The nomination of current FDA Commissioner Robert Califf was originally opposed by the Project on Government Oversight, a nonpartisan watchdog group due to his ties to the pharmaceutical industry. The group noted he received more than $1 million in pharma payments between 2017 and his nomination in 2021. Still, Califf was easily confirmed by the Senate for a second term as commissioner in 2022 after committing to sell any relevant stocks and end his financial relationships with pharma companies.
The process isn’t always smooth. In 2006, Lester Crawford, who was commissioner of the FDA for just two months in 2005, pled guilty to conflict of interest and failing to disclose financial holdings that were under the agency’s purview and was fined $90,000 in 2007.
While the timing of Senate hearings for Makary is not yet set, he will face a similar review of his background. The chief of Islet Transplant Surgery at Johns Hopkins, Makary has authored three healthcare books critical of the American healthcare system. He holds board seats and advising roles with several companies, including a director position on the board at Harrow, an ophthalmic company from which he earned $40,000 in compensation in 2023.
Makary also serves as a public adviser to health policy research organization Paragon Health Institute and advises insurance provider Sidecar Health and benefits brokerage Nava.
Perhaps most notably, he is the chief medical officer at Sesame, a telehealth company that offers compounded GLP-1 medications among other services.
The connection to Sesame could become a point of contention as the FDA wrestles with GLP-1 drugmakers over how to handle compounded versions of the blockbuster weight loss and diabetes drugs.
Due to high demand of the popular medications from Eli Lilly and Novo Nordisk, compounded versions were allowed to be sold in bulk when the branded drugs were on the FDA’s shortage list. While those shortages are now officially resolved, the FDA is facing pushback for taking steps to end compounders ability to produce the knock-off versions of drugs.
Assuming both are confirmed by the Senate, Makary would report to Kennedy, who’s regularly argued against researchers with industry ties receiving federal funding or serving on advisory committees to the FDA or U.S. Department of Agriculture.
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- Source: https://www.biopharmadive.com/news/makary-fda-commissioner-hearings-conflicts-interest/734827/