FDA Tobacco Science Officer Takes Job at Philip Morris

A Food and Drug Administration official with considerable power over authorization decisions for e-cigarettes and products intended to curb smoking resigned Tuesday to work at Philip Morris International, the global tobacco conglomerate and maker of Marlboros.

The official, Matt Holman, was chief of the science office at the agency’s Center for Tobacco Products. In a memo to staff on Tuesday, Brian King, the center’s director, wrote that Dr. Holman had announced that he would be leaving, effective immediately, to join Philip Morris. The memo said that Dr. Holman had been on leave and, in accordance with the agency’s ethics policies, he had recused himself from all work at the tobacco center “while exploring career opportunities outside of government.”

Mr. King praised Dr. Holman’s 20 years of work at the FDA, where in recent years he has been “preparing and overseeing the review” of marketing applications for e-cigarettes and other nicotine delivery products. Dr. Holman said in an interview Wednesday that his exact role at Philip Morris had so far been largely defined, but added that he would work on tobacco harm reduction efforts and provide input on regulatory filings to the agency. .

His resignation adds further turmoil to the agency’s tobacco control division, which is undergoing a review ordered by Dr. Robert Califf, the agency’s commissioner. The division also lost its former director, Mitch Zeller, who retired in April.

To critics, Dr. Holman’s move is a particularly troubling example of the “revolving door” between federal officials and the industries they regulate; in this case, one that has garnered a high degree of public mistrust. He also raised questions about agency approvals, including that of Philip Morris’s IQOS, a tobacco device that “heats without burning,” which some researchers say is troubling. IQOS is not sold in the US market now due to patent litigation, but if that were resolved, the device would face further FDA reviews.

Federal rules governing “revolving door” career changes don’t prevent an official from overseeing regulatory affairs one week and joining a corporation with products under review the next.

“This is legal. That’s the bottom line,” said Dr. Michael Carome, director of the Public Citizen health research group. “It’s this kind of revolving door movement that really undermines the public’s trust in the agency.”

Federal rules prohibit Dr. Holman from appearing before the FDA in matters in which he was “personally and substantially involved while in government service.”

Credit…US Food and Drug Administration

Dr. Holman said he consulted with the agency’s ethics lawyers before starting labor discussions earlier this month. He said he was drawn to Philip Morris because he believed the company was committed to moving cigarette smokers to non-combustible and less harmful products.

“They are taking the steps that I think would align with that goal,” Dr. Holman said. “And that’s what really caught my attention about PMI. I go there not to help them sell more cigarettes, quite the opposite.”

He brushed off the “revolving door” criticism, saying that if that was his motivation, he could have left the agency for the industry many years ago. But lawmakers and some public health experts criticized Dr. Holman’s choice and his effect on FDA decision-making.

“It is embarrassing for the FDA, which sees itself as a public health agency, to have its employees go to a company that is a leader in manufacturing death,” said Micah Berman, an associate professor of public health and law at the FDA. Ohio State University. .

Rep. Raja Krishnamoorthi, a Democrat from Illinois, was similarly critical. “The revolving door between the FDA and the industries it is tasked with regulating is extremely concerning,” he said in a statement. “While some, including PMI, may argue that his hiring is evidence of PMI’s purported commitment to take the health impacts of its products more seriously, I won’t hold my breath.”

As chief of the FDA’s scientific bureau, Dr. Holman played a key role in the approvals of e-cigarettes and similar devices, which manufacturers have had to review to stay on the market in recent years.

IQOS, the Philip Morris product that Altria is licensed to distribute in the United States, was one of the approved products. It is sold in Korea, Japan and other countries. A company spokesman said sales in the United States were expected to resume next year, but before then it must undergo further agency reviews.

Critics of the IQOS approval include Stanton Glantz, a retired professor of medicine, and his colleagues at the University of California, San Francisco, who published a study saying the device contained toxins, some potentially carcinogenic and others at higher levels. than in combustible cigarettes. The agency’s approval “ignored valid scientific evidence and misapplied the public health standard required by law,” concluded the study published in the journal Tobacco Control.

Dr. Glantz said Wednesday that Dr. Holman ignored another important study showing that e-cigarette use, outside of controlled studies of quitting efforts, was not associated with reduced rates of smoking. He said the approvals have done little to address the problem of dual use, or the use of cigarettes and e-cigarettes, which is worse for overall health. On Dr. Holman’s departure, Dr. Glantz said, “Good riddance.”

“He is the one who signed these approvals,” he said. “They deal with all these problems by ignoring them, relying on outdated studies.”

Among the FDA’s recent controversies was the June decision to deny marketing authorization for Juul Labs e-cigarettes. The agency has since relented and announced a review of its decision.

In a court filing, Juul cited the authorization given to Philip Morris as a reason it would likely prevail, saying IQOS was approved despite a dozen chemicals in IQOS sprays being “potentially genotoxic and/or carcinogenic.” and were “present in a higher concentration.”[s]’ than in combustible cigarette smoke”.

Dr. Holman said many agency decisions have their critics, but he believed the IQOS authorization was justified on a full review of the data.

Philip Morris said in a statement that Dr. Holman “is committed to helping today’s adult smokers access scientifically proven smoke-free alternatives while protecting youth. We look forward to having him join our team as we continue to pursue a smoke-free future.”

The company also recently hired Keagan Lenihan, a former FDA chief of staff, as vice president of government affairs.

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