The Food and Drug Administration officer, who has significant authority over approvals for e-cigarettes and smoking-restriction products, resigned on Tuesday to work for Philip Morris International, a global tobacco conglomerate and maker of Marlboros.
The official, Matt Holman, was the head of the science department at the agency’s Tobacco Products Center. In a memo to staff on Tuesday, Brian King, director of the center, wrote that Dr. Holman announced that he was leaving—effective immediately—to join Philip Morris. The memo said that Dr. Holman was on vacation and, in accordance with the agency’s ethics policy, turned down any tobacco center job, “exploring career opportunities outside of government.”
mr. King praised Holman’s 20 years with the FDA, where in recent years he “prepared and supervised 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 loosely defined, but added that he will work on tobacco harm reduction efforts and provide some regulatory input to the agency.
His resignation adds even more turmoil to the agency’s tobacco control department, which is being reviewed. by order of Dr. Robert Kaliff, agency commissioner. The division also lost its longtime director, Mitch Zeller, who retired in April.
Critics Dr. Holman’s actions are a particularly troubling example of a revolving door between federal officials and the industries they regulate; in this case one that caused a high degree of public distrust. It also raised questions about approval by agencies, including Philip Morris’s IQOS, a tobacco device that “heats, not burns,” which some researchers found disturbing. IQOS is currently not sold in the US market due to patent disputes, but if this is resolved, the device may face new FDA reviews.
federal rules governing Revolving door career moves do not prevent an official from overseeing regulation one week and joining a corporation with the products in question the next.
“It’s legal. That’s the point,” said Dr. Michael Carome, director of public health research group Public Citizen. “It’s this type of revolving door that really undermines public trust in the agency.”
Federal regulations prohibit Dr. Holman will not appear before the FDA on matters in which he “personally and substantially participated in his public service.”
Dr. Holman said he consulted with ethics agency lawyers before starting discussions on the work earlier this month. He said he was attracted to Philip Morris because he believed the company was committed to encouraging cigarette smokers to use non-flammable and less harmful products.
“They are taking actions that I think are consistent with such a goal,” the doctor said. Holman said. “And that’s what really got my attention to PMI. I’m not going there to help them sell more cigarettes, but the other way around.”
He brushed aside “revolving door” criticisms, stating that if that had been his motivation, he might have left the agency for the industry years ago. But lawmakers and some public health experts have criticized the doctor. Holman’s choice and its impact on FDA decision making.
“The US Food and Drug Administration (FDA), which considers itself a public health agency, is embarrassed when its employees approach a company that is a leading producer of deaths,” said Mika Berman, associate professor of public health and law at Ohio State University. .
Representative Raja Krishnamurthy, Democrat of Illinois, was equally critical. “The revolving door between the FDA and the industries it is charged with regulating is extremely disturbing,” he said in a statement. “While some, including PMI, may argue that their hiring 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 science department, Dr. Holman has played a key role in the approval of e-cigarettes and similar devices, which in recent years, manufacturers have had to submit for review in order to stay on the market. The FDA said that before issuing an order on an application, it is reviewed by several members of the Tobacco Center’s science department, including the director.
IQOS, a Philip Morris product that Altria is licensed to distribute in the US, was one of the approved products. Sold in Korea, Japan and other countries. A spokesperson for the company said US sales are expected to resume next year, but may need to go through another review before doing so.
Critics of IQOS’s endorsement include Stanton Glantz, a retired professor of medicine, and colleagues at the University of California, San Francisco, who published study stating that the device contains toxins, some of which are potentially carcinogenic and some in higher concentrations than in combustible cigarettes. The agency’s assertion “disregarded valid scientific evidence and misapplied the public health standard mandated by law,” according to a study published in the journal Tobacco Control. concluded.
Dr. Glantz said on Wednesday that Dr. Holman ignored another important study showing that e-cigarette use — outside of controlled studies of smoking cessation efforts — was not associated with reduced smoking rates. He said the approvals did little to address the dual use or use of cigarettes and e-cigarettes, which worsens overall health. Or Dr. Holman’s departure, dr. Glantz said: “Good riddance.”
“He is the one who signed those permits,” he said. “They solve all these questions by ignoring them, relying on outdated research.”
Among the FDA’s recent controversies was its decision in June to deny marketing authorization. Electronic cigarettes Juul Labs. The agency has since relented, announcing a reconsideration of its decision.
In with litigationJuul cited the approval granted by Philip Morris as the reason why it would likely prevail, stating that IQOS was approved despite the fact that a dozen chemicals in IQOS aerosols were “potentially genotoxic and/or carcinogenic ‘ and ‘were present at higher concentrations’.[s]than in combustible cigarette smoke.
Dr. Holman said many of the agency’s decisions have their critics, but he believes the IQOS authorization is justified after a full review of the data.
Philip Morris said in a statement that Dr. Holman “is committed to helping existing adult smokers access evidence-based smoke-free alternatives while protecting youth. We look forward to having him join our team as we continue to strive for a smoke-free future.”
The company also recently hired Keegan Lenihan, a former chief of staff for the FDA, as vice president of government affairs.