FDA Tobacco Science Employee Takes a Job at Philip Morris

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

The employee, Matt Holman, was head of the science office at the agency’s Tobacco Products Center. In a memo to staff on Tuesday, Brian King, director of the center, wrote that Dr. Holman had announced that he would leave – effective immediately – to join Philip Morris. The memo said that Dr. Holman was on leave and, in accordance with the agency’s ethics policies, had refused to work in tobacco centers “while exploring career opportunities outside of government”.

Mr. King praised Dr. Holman 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 on Wednesday that his exact role at Philip Morris has so far been largely defined, but added that he would work on tobacco harm reduction efforts and provide some information on regulatory submissions to the agency.

His resignation adds more 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 longtime director Mitch Zeller, who retired in April.

For critics, Dr. Holman is a particularly troubling example of the “revolving door” between federal employees and the industries they regulate; in this case, one that has earned a high degree of public distrust. He also raised questions about agency approvals, including that of Philip Morris’ IQOS, a “non-burning” tobacco device, which some researchers found worrying. The IQOS is not sold in the US market right now because of patent litigation, but if this were resolved, the device would face further FDA review.

Federal rules governing “revolving door” career moves do not preclude an employee from overseeing regulatory issues one week and joining a corporation with products under review the next.

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

Federal rules prohibit Dr. Holman to appear before the FDA on matters in which he “participated personally and substantially during government service.”

Credit…US Food and Drug Administration

Dr. Holman said he consulted with the agency’s ethics attorneys before starting work discussions earlier this month. He said he was attracted to Philip Morris because he saw the company as committed to moving smokers to non-combustible and less harmful products.

“They are taking actions that I think would align with that goal,” said Dr. Holman. “And that’s what really drew my attention to PMI. I go there not to help them sell more cigarettes, but 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 and its effect on FDA decision making.

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

Representative Raja Krishnamoorthi, a Democrat from Illinois, was similarly critical. “The revolving door between the FDA and the industries it is charged with regulating is extremely disruptive,” he said in a statement. “While some, including PMI, might argue that his hiring is evidence of PMI’s purported commitment to taking the health impacts of its products more seriously, I’m not going to hold my breath.”

As head of the FDA’s science office, Dr. Holman has played a key role in the approvals of e-cigarettes and similar devices, which manufacturers have had to submit for review to stay on the market in recent years.

IQOS, a 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 US sales are expected to resume next year, but must undergo further agency reviews before then.

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 “disregarded 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 Holman ignored another large study showing that e-cigarette use — outside of controlled studies of efforts to quit smoking — was not associated with reduced rates of smoking. He said the approvals did little to address the problem of dual use, or use of e-cigarettes and e-cigarettes, which is worse for overall health. About the departure of Dr. Holman, Dr. Glantz said, “Have a nice trip.”

“It was he who signed these approvals,” he said. “They deal with all these issues by ignoring them, relying on outdated studies.”

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

In a court filing, Juul cited the authorization granted to Philip Morris as a reason he would likely prevail, saying that IQOS was approved even though a dozen chemicals in IQOS aerosols were “‘potentially genotoxic and/or carcinogenic’ and were ‘ present in greater concentration[s]’ than in combustible cigarette smoke.”

Dr. Holman said many agency decisions have their critics, but he believes IQOS authorization was secured in a thorough review of the data.

Philip Morris said in a statement that Dr. Holman “is committed to helping existing 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, former FDA chief of staff, as vice president of government affairs.

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