A staff member of the Food and Drug Administration, who has considerable authority in deciding to approve products aimed at controlling e-cigarettes and smoking, resigned on Tuesday to work for Philip Morris International, a global tobacco conglomerate and manufacturer of Marlboro. rice field.
Staff Matt Holman was the director of science at the agency’s Tobacco Products Center. In a note to staff on Tuesday, Center Director Brian King wrote that Dr. Holman had announced that he would leave to join Philip Morris-which would come into effect soon. According to this memo, Dr. Holman is on vacation and, in line with government ethical policy, withdraws from all tobacco center jobs “while exploring out-of-government career opportunities.” rice field.
King praised Dr. Holman for working at the FDA for 20 years. In recent years he has been “preparing and supervising reviews” for marketing applications for e-cigarettes and other nicotine delivery products. In an interview Wednesday, Dr. Holman had broadly defined his exact role at Philip Morris, but he worked on tobacco harm reduction efforts and provided some information about his submission to the authorities. He added that he would provide it.
His resignation adds further confusion to the agency’s tobacco control department, which has been reviewed by the agency’s commissioner, Dr. Robert Caliph. The division also lost its longtime director Mitch Zeller, who retired in April.
For critics, Dr. Holman’s move is a particularly worrisome example of a “revolving door” between federal authorities and the industry they regulate, in this case a highly distrustful industry. Questions have also been raised about agency approval, such as the approval of the IQOS of Philip Morris, a “heat-not-burn tobacco” tobacco device that some researchers have problems with. IQOS is not currently sold in the US market due to patent proceedings, but if they are resolved, the device will face a new FDA review.
Federal government Rule to rule The “revolving door” career movement does not prevent authorities from overseeing regulatory issues for a week and joining the company with the product under review.
“This is legal, and that’s the point,” said Dr. Michael Carom, director of the Public Citizen Health Research Group. “This kind of revolving door movement actually undermines public confidence in government agencies.”
Federal regulations prohibit Dr. Holman from appearing at the FDA on issues of “personal and substantive participation in government service.”
Dr. Holman said he consulted with the agency’s ethics lawyer before starting work discussions earlier this month. Philip Morris said he was attracted to Philip Morris because he believed he was working on the goal of moving smokers to non-flammable, harmless products.
“They are acting in line with such goals,” Dr. Holman said. “And that’s why I really turned my attention to PMI. I don’t go there to help them sell more cigarettes, but vice versa.”
He wiped out criticisms of “revolving doors” and said he could have left the agency for industry many years ago if that was his motive. However, lawmakers and some public health experts have criticized Dr. Holman’s choice and its impact on the FDA’s decision-making.
Mika Berman, an associate professor of public health law at Ohio State University, said: ..
Illinois Democrat Raja Krishnamti was similarly critical. “The revolving door between the FDA and the industry in which it is regulated is very disturbing,” he said in a statement. “Some people, including PMI, may argue that their employment is evidence of PMI’s claim that they take the health effects of their products more seriously, but I don’t hold my breath. . “
As Head of the FDA Science Office, Dr. Holman played a key role in the approval of e-cigarettes and similar devices. These devices have recently had to be submitted by manufacturers for review in order to remain on the market.
IQOS, a Philip Morris product licensed by Altria to distribute in the United States, approved product. Sold in South Korea, Japan and other countries. A spokesman for one company said US sales are expected to resume next year, but need to be reviewed by a new agency before that.
IQOS-approved critics include retired medical professor Stanton Glantz and colleagues at the University of California, San Francisco. study The device contains toxins, some of which may be carcinogenic and some of which are at higher levels than flammable cigarettes, he said. Authorities’ approval “ignored valid scientific evidence and misapplied the public health standards required by law,” said a study by the journal Tobacco Control. Conclusion..
Dr. Grants said on Wednesday that Dr. Holman ignored another major. study The use of e-cigarettes has been shown to have been associated with lower smoking prevalence, except in controlled studies of smoking cessation efforts. He said the approval did little to address the issue of dual-use, or tobacco and e-cigarette use, which is worse for overall health. Regarding Dr. Holman’s departure, Dr. Grants said it was “good ridiculous.”
“He is the one who approved these approvals,” he said. “They address all these issues by relying on outdated research and ignoring it.”
One of the FDA’s recent controversies was a June decision to refuse Juul Labs’ marketing approval for e-cigarettes. Since then, the agency has forgiven and announced a review of its decision.
and Submission to courtPhilip Morris said that the 12 chemicals contained in IQOS aerosols were “potentially genotoxic and / or carcinogenic” and “even in high concentrations” were approved by IQOS, Juul said. I cited this as the reason why the approval granted to is likely to be widespread.[s]”More than flammable cigarette smoke.”
Dr. Holman said there were critics of many government decisions, but he believed that a full review of the data would require IQOS approval.
In a statement, Philip Morris said Dr. Holman “is committed to helping existing adult smokers protect young people while gaining access to scientifically proven smoking cessation alternatives. We look forward to joining our team as he continues to pursue the future. “
The company recently hired Keagan Lenihan, the former FDA Chief of Staff, as Vice President of Government.
