A Food and Drug Administration official with considerable power over authorization decisions for products aimed at curbing e-cigarettes and smoking, working for Philip Morris International, a global tobacco conglomerate and maker of Marlboros, resigned Tuesday.
The officer, Matt Holman, was the head of the science office at the agency’s Center for Tobacco Products. In a memo to staff on Tuesday, the center’s director, Brian King, 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 that in line with the agency’s ethics policies, he had “dissociated himself from all tobacco center work while exploring career opportunities outside of government”.
Mr. King commended Dr. Holman’s 20 years of work at the FDA, where he has been “preparing and reviewing the marketing applications” of e-cigarettes and other nicotine-delivery products in recent years. Dr. Holman said in an interview on Wednesday that his exact role at Philip Morris was still broadly defined, but said he would work on efforts to reduce tobacco harms and on regulatory submissions to the agency. Will provide some input.
His resignation adds further turmoil to the agency’s tobacco control division, which is being ordered by the agency’s commissioner, Dr. Robert Califf, to be reviewed. The division also lost its longtime director, Mitch Zeller, who retired in April.
To critics, Dr. Holman’s move is a particularly concerning example of a “revolving door” between federal officials and the industries they regulate; In this case, that has elicited a high degree of public distrust. It has also raised questions about the agency’s approval of Philip Morris’s IQOS, a “heat-not-burn” tobacco device that some researchers have found troubling. IQOS is no longer sold in the US market due to patent litigation, but if this is resolved, the device could face new FDA reviews.
Federal rules governing “revolving door” career moves don’t prevent an officer from overseeing regulatory matters one week and joining a corporation with products under review the next.
“It’s legal. It’s the bottom line,” said Dr. Michael Carrom, director of the Public Citizens Health Research Group.
Federal rules prohibit Dr. Holman from appearing before the FDA in cases in which he “personally and substantially participated in the course of government service.”
Dr Holman said he consulted with agency ethics lawyers before starting job discussions earlier this month. He said he was attracted to Philip Morris because he saw the company as committed to the goal of moving cigarette smokers to non-combustible and less harmful products.
“They are taking actions that I think would align with such a goal,” Dr. Holman said. “And that’s what really drew my attention to PMI, I’m not going there to help them sell more cigarettes, but vice versa.”
He dismissed criticisms of “Revolving Door”, saying that if it had been his motivation, he could have left the agency for the industry several years ago. But lawmakers and some public health experts criticized Dr. Holman’s choice and its impact on FDA decision-making.
“It’s shameful for the FDA, which sees itself as a public health agency, to move its employees to a company that is a cause of death,” said Micah Berman, associate professor of public health and law at Ohio State University. major producer.” ,
Representative Raja Krishnamurthy, a Democrat from Illinois, was equally critical. “The revolving door between the FDA and the industries it has been tasked with regulating is extremely disturbing,” he said in a statement. “While some, including PMI, may argue that their fare is evidence of PMI’s perceived commitment to taking the health effects of its products more seriously, I won’t hold my breath.”
As head of the FDA’s Office of Science, Dr. Holman was instrumental in the approval of electronic cigarettes and similar devices, which manufacturers have had to submit for review in recent years to remain on the market. The FDA said that before an order is issued on an application, it is reviewed by several employees in the Tobacco Center’s Office of Science, including the director.
iQOS, a Philips Morris product that Altria licenses 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 US sales are expected to resume next year, but may have to go through another review before that.
Critics of the IQOS approval include Stanton Glantz, a retired professor of medicine and his colleague at the University of California, San Francisco, who published a study suggesting that the device contained toxins, some potentially carcinogenic and some compared to combustible cigarettes. were at a high level. The agency’s acceptance “disregards valid scientific evidence and unfairly applies a public health standard mandated by law,” concluded the study in the journal Tobacco Control.
Dr. Glantz said Wednesday that Dr. Holman overlooked another large study that showed e-cigarette use — outside of controlled studies of quit attempts — was not associated with lower rates of smoking. He said the approvals have done little to tackle the problem of dual use, or using cigarettes and e-cigarettes, which is worse for overall health. Of Dr. Holman’s departure, Dr. Glantz said, “Good riddance.”
“He is the one who signed these approvals,” he said. “They tackle all of these issues by ignoring them, relying on older studies.”
Among the most recent controversy was the FDA’s decision in June to deny marketing authorization to Juul Labs’ e-cigarettes. Since then, the agency has relented, announcing a review of its decision.
In a court filing, Juul cited the authorization granted to Philip Morris that it would likely prevail, saying that IQOS was approved, even though a dozen chemicals in IQOS aerosols are “‘potentially genotoxic and/or were ‘carcinogenic’ and ‘present in high concentrations’.[s]’ compared to flammable cigarette smoke.
Dr. Holman said many of the agency’s decisions had their critics, but believed that a full review of the data was needed for IQOS authorization.
Philip Morris said in a statement that Dr. Holman is “committed to helping existing adult smokers access scientifically proven smoke-free options while protecting youth. We look forward to her joining our team.” as we continue to pursue a smoke-free future.”
The company also recently appointed former FDA chief of staff Keegan Lenihan as vice president of government affairs.