Matt Holman, former director of the Tobacco Science Office at the FDA, has recently taken a position with Philip Morris International. During his time at the FDA, Holman was responsible for approving electronic cigarettes and other reduced-risk products. Critics see Holman's departure as yet another example of federal officials switching to the industries they previously regulated.
An official of the U.S. Food and Drug Administration (FDA), Matt Holman, resigned on Tuesday to join Philip Morris International, the manufacturer of Marlboros. Holman held significant power in the authorization decisions for electronic cigarettes and alternative tobacco products.
Matt Holman, the director of the scientific office at the FDA's Center for Tobacco Products, has announced that he will be leaving his position immediately to join Philip Morris. This was stated in a memo sent to staff on Tuesday by the Center's director, Brian King. The memo explained that Dr. Holman had been on leave and had adhered to the institution's ethical policy by avoiding all work related to the Center for Tobacco Products while exploring career opportunities outside of government.
Brian King praised Dr. Holman's 20-year tenure at the FDA, during which he has been overseeing and preparing the review of marketing applications for electronic cigarettes and other nicotine delivery products in recent years. In a Wednesday interview, Dr. Holman said that his exact role at Philip Morris has been widely defined thus far, but he added that he will be focused on reducing tobacco harm and providing some input on regulatory filings submitted to the agency.
His resignation has further plunged the tobacco control division of the FDA into chaos, as the department is undergoing a review ordered by FDA Commissioner Dr. Robert Califf. Additionally, it has lost its long-time director, Mickey Zele, who just retired in April.
The departure of Dr. Holman has raised concerns among critics regarding the issue of federal officials moving between government posts and industry they regulate, and has further exacerbated public distrust. Additionally, his resignation has brought into question the approval process of products such as the IQOS tobacco device by Philip Morris. Due to patent lawsuits, the IQOS is not currently available on the US market, but if these issues are resolved, the device may seek new FDA approval.
This is a legitimate bottom line," said Dr. Michael Carome, director of the Public Citizen Health Research Group. "It is these kinds of back and forth measures that undermine public confidence in the FDA.
Dr. Holman stated that prior to beginning work discussions earlier this month, he consulted with an ethical lawyer at the FDA. He explained that he was drawn to working with Phillip Morris because he believes the company is committed to transitioning smokers to non-combustible, less harmful products.
Dr. Holman stated, "Philip Morris International is taking actions that align with my objectives. This is what truly caught my attention with PMI, and I am not here to help them sell more cigarettes.
He dismisses criticism of his "revolving door" situation, stating that if that was his motive, he would have left the FDA for the tobacco industry many years ago. However, lawmakers and some public health experts have criticized Dr. Holman's choice and its potential impact on FDA decision-making.
Micah Berman, an associate professor of public health and law at Ohio State University, expressed embarrassment at the fact that the United States Food and Drug Administration (FDA), which considers itself a public health agency, sent its employees to a leading death manufacturing company.
Democratic Representative Raja Krishnamoorthi of Illinois also shares the same critical attitude, stating in a statement: "The back-and-forth between the FDA and the industries it regulates is deeply troubling. While some, including PMI, may argue that this demonstrates PMI's commitment to more seriously examining the health effects of its products, I will not sit idly by.
Dr. Holman, the head of the FDA's Office of Science, has played a crucial role in approving e-cigarettes and related devices. In recent years, manufacturers have been required to submit PMTA reviews in order to continue selling their products on the market.
The IQOS product from Philip Morris International is being sold in countries such as South Korea, Japan, and other nations. A spokesperson for the company stated that they are expecting to resume sales in the United States next year, though another PMTA review may be necessary before then.
Dr. Holman stated that many decisions made by the FDA have been criticized, but he believes that authorization for IQOS can be ensured based on a thorough review of the data.
In a statement, Philip Morris International said Dr. Holman is "committed to helping adult smokers access scientifically substantiated smoke-free alternatives while also protecting youth. We look forward to welcoming him to our team as we continue to pursue a smoke-free future.
Phimo Tobacco has recently hired former head of the FDA's office, Keagan Lenihan, as its vice president of government affairs.
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