A Food and Drug Administration official with sweeping power over licensing decisions for e-cigarettes and smoking cessation products resigned on Tuesday to work for Philip Morris International, the global tobacco conglomerate and manufacturer of Marlboros.
The official, Matt Holman, was chief of the science office at the agency’s Tobacco Products Center. In a memo to staff on Tuesday, Brian King, the centre’s director, wrote that Dr Holman had announced he would be leaving – effective immediately – to join Philip Morris. The memo said Dr. Holman had been on leave and, in accordance with agency ethics policies, had recused himself from any tobacco center work “while exploring career opportunities outside of government.”
Mr. King praised Dr. Holman’s 20 years of work at the FDA, where he has in recent years “prepared and overseen 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 had thus far been largely defined, but added that he would work on tobacco harm reduction efforts and provide information on regulatory submissions 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 longtime manager, Mitch Zeller, who retired in April.
For critics, Dr. Holman’s decision is a particularly concerning example of the “revolving door” between federal officials and the industries they regulate; in this case, one that aroused a high degree of public distrust. It also raised questions about agency approvals, including that of Philip Morris’ IQOS, a “heating without burning” tobacco device, which some researchers found troubling. IQOS is not currently being sold in the US market due to a patent dispute, but if this is resolved, the device could face further criticism from the FDA.
Federal rules governing “revolving door” career moves do not prevent a public servant from overseeing regulatory matters one week and joining a company with products under consideration the next week.
“It’s legal. That’s the bottom line,” said Dr. Michael Carome, director of health research group Public Citizen. “It’s this type of revolving door movement that really undermines public trust in the agency.”
Federal rules prohibit Dr. Holman from appearing before the FDA on matters in which he “has personally and substantially participated in government service.”
Dr. Holman said he consulted with agency ethics lawyers before beginning employment talks earlier this month. He said he was drawn to Philip Morris because he saw the company as committed to the goal of moving cigarette smokers to non-combustible, less harmful products.
“They are taking the steps that I think would align with such a goal,” Dr. Holman said. “And that’s what really caught my eye on PMI. I’m not going there to help them sell more cigarettes, but on the contrary.”
He brushed off ‘revolving door’ criticism, saying if that was his motivation, he could have left the agency for the industry many years ago. But lawmakers and some public health experts have criticized Dr. Holman’s choice and its effect on FDA decision-making.
“It’s embarrassing for the FDA, which considers itself a public health agency, to have its employees go to a company that is a leading death maker,” said Micah Berman, associate professor of public health and of law at The Ohio State University. .
Rep. Raja Krishnamoorthi, a Democrat from Illinois, was equally critical. “The revolving door between the FDA and the industries it is charged with regulating is extremely concerning,” he said in a statement. “While some, including PMI, may argue that their hiring is evidence of PMI’s alleged commitment to taking the health effects of its products more seriously, I won’t hold my breath.”
As chief 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 in the market in recent years.
IQOS, the Philip Morris product that Altria has a license to distribute in the United States, was one of the products approved. It is sold in Korea, Japan and other countries. A company spokesperson said sales in the United States are expected to resume next year, but may need to undergo another review before then.
Critics of the IQOS endorsement include retired medical professor Stanton Glantz and his colleagues at the University of California, San Francisco, who published a study indicating the device contained toxins, some potentially carcinogenic. and others at higher levels than in combustible cigarettes. The agency’s approval “disregarded sound scientific evidence and misapplied the public health standard mandated by law,” the study concluded in the journal Tobacco Control.
Dr. Glantz said on Wednesday that Dr. Holman ignored another major study showing that e-cigarette use — outside of controlled studies on quitting efforts — was not associated with reduced smoking rates. . He said the approvals had done little to address the problem of dual use, or the use of cigarettes and e-cigarettes, which is worse for health in general. Of Dr. Holman’s departure, Dr. Glantz said, “Good riddance.
“He’s the one who signed those endorsements,” he said. “They deal with all these issues by ignoring them, relying on outdated studies.”
Among the recent controversies of the FDA, the decision in June to deny marketing authorization to e-cigarettes from Juul Labs. Since then, the agency has given in, announcing a review of its decision.
In a court filing, Juul cited the clearance granted to Philip Morris as a reason it would likely prevail, saying IQOS was approved even though a dozen chemicals in IQOS aerosols were “potentially genotoxic and/or carcinogens” and were “present in higher concentration”.[s]’ than in combustible cigarette smoke.
Dr. Holman said many agency decisions had their critics, but he believed allowing IQOS was warranted on a full 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 young people. 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.
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