A Food and Drug Administration official with significant power over authorization decisions for e-cigarettes and products aimed at curbing smoking resigned Tuesday to work for Philip Morris International, the global tobacco conglomerate and maker of Marlboros.
The official, Matt Holman, was chief of science 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 was leaving – effective immediately – to join Philip Morris. The memo stated that Dr. Holman had been on leave and, in accordance with the agencies’ ethics policies, had retired from all work in a 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 “prepared and supervised the evaluation of marketing applications for e-cigarettes and other nicotine products.” dr. Holman said in an interview on Wednesday that his exact role at Philip Morris had been broadly defined so far, but added that he would work on efforts to reduce tobacco harm and provide some input on regulations submitted to the agency.
His resignation is fueling further turmoil in the agency’s tobacco control division, which is currently under 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 a particularly troubling example of the “revolving door” between federal officials and the industries they regulate; in this case, one that has created a high degree of mistrust in the public. It has also raised questions about regulatory approvals, including that of Philip Morris’s IQOS, a “heat-not-burn” tobacco device, which some researchers have found troubling. IQOS is now not sold in the US market due to patent litigation, but if that were resolved, the device would face new FDA reviews.
federal rules that apply “Revolving door” career moves don’t stop a government official from overseeing regulatory affairs one week and joining a company with products under review the next.
“This is legal. That’s the bottom line,” says Dr Michael Carome, director of the Public Citizen Health research group. “It’s these kinds of revolving doors that really undermine public confidence 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”.
dr. Holman said he consulted with the agency’s ethics lawyers before starting work discussions earlier this month. He said he was drawn to Philip Morris because he saw the company as committed to the goal of transitioning cigarette smokers to non-combustible and less harmful products.
“They are taking the actions that I think are appropriate for such a purpose,” said Dr. holman. “And that’s what drew my attention to PMI. I’m not going there to help them sell more cigarettes, but on the contrary.”
He brushed aside criticism from the “revolving door,” 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 let its employees go to a company that is a leading manufacturer of death,” said Micah Berman, an associate professor of public health and law at Ohio State University. .
Representative Raja Krishnamoorthi, an Illinois Democrat, was equally critical. “The revolving door between the FDA and the industries it must regulate is extremely troubling,” he said in a statement. “While some, including PMI, argue that their appointment is evidence of PMI’s alleged commitment to take the health effects of its products more seriously, I won’t be holding my breath.”
As head of the FDA’s science bureau, Dr. Holman played a key role in the approval of electronic cigarettes and similar devices, which manufacturers had to submit for review in recent years to stay on the market.
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 spokesperson said sales in the US are expected to resume next year, but that would require the company to undergo new assessments.
Critics of the IQOS endorsement include Stanton Glantz, a retired professor of medicine, and his colleagues at the University of California, San Francisco, who study say the device contained toxins, some potentially carcinogenic and some in higher levels than in combustible cigarettes. The agency’s approval “disregarded valid scientific evidence and misapplied the public health standard imposed by law,” the study found in the journal Tobacco Control. concluded.
dr. Glantz said on Wednesday that Dr. Holman ignored another major study showing that e-cigarette use – outside of controlled trials of quitting attempts – was not associated with reduced smoking rates. He said 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. About the departure of Dr. Holman said Dr. Glantz: “Relieved.”
“He’s the one who signed these approvals,” he said. “They’re tackling all these problems by ignoring it, by relying on outdated studies.”
One of the FDA’s recent controversies was its decision in June to deny marketing authorization to: Juul Labs e-cigarettes. Since then, the agency has relented and announced a review of its decision.
In a submit to courtJuul cited the authorization granted to Philip Morris as one reason likely to prevail, and said IQOS had been approved, even though a dozen chemicals in IQOS aerosols were “‘potentially genotoxic and/or carcinogenic” and “present in higher concentrations.” ‘[s]’ than in combustible cigarette smoke.”
dr. Holman said many agency decisions have been criticized, but he believed IQOS authorization was warranted after a full review of the data.
Philip Morris said in a statement that Dr. Holman “is committed to helping existing adult smokers access science-backed smoke-free alternatives while protecting youth. We look forward to him joining 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.