FDA’s top tobacco scientist takes job at Marlboro-maker Philip Morris

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FDA’s top tobacco scientist takes job at Marlboro-maker Philip Morris

The top tobacco scientist at the Food and Drug Administration has left his job to go work for tobacco giant Philip Morris International (PMI), best known as the maker of Marlboro cigarettes.

It is the second high-profile FDA hire by PMI in recent months, and it comes at a time when the FDA is struggling to regulate the evolving smoking and vaping products by companies such as PMI. Earlier this month, for instance, the FDA announced an embarrassing backpedal in its bungled attempt to ban Juul e-cigarette products. Juul—largely blamed for an epidemic of youth vaping—is partly owned by Altria, which spun-off PMI in 2008.

On Tuesday, Matt Holman, director of the Office of Science at the FDA’s Center for Tobacco Products (CTP), announced his departure, effective immediately, to accept a position at PMI. Holman, a biochemist by training, was at the FDA for over 20 years and director of the CTP’s Office of Science since 2017.

In a memo later Tuesday, CTP Director Brian King relayed the news of Holman’s exit to staff and noted that he had been on leave for an unspecified amount of time. Holman had “recused himself, consistent with agency ethics policies, from all CTP/FDA work while exploring career opportunities outside of government,” King wrote.

In a statement, an FDA spokesperson added that “agency employees are free to pursue employment outside of the government and are required to immediately disclose that they are exploring opportunities outside the government.”

Regulatory headaches

It’s unclear when Holman had recused himself, but it appears to have been less than four months ago. On March 18, Holman signed off on the third generation of PMI’s heated, smokeless tobacco product, IQOS. Holman also signed off on PMI’s initial IQOS application in 2020.

Meanwhile, in May, PMI hired Keagan Lenihan, who had held the positions of FDA’s associate commissioner for external affairs and strategic initiatives and then the FDA’s chief of staff. At PMI, she is now vice president of government affairs and public policy and head of the company’s DC office. PMI has not disclosed the title of Holman’s new role.

The moves come as the FDA struggles to keep up with e-cigarettes and new vaping products. In addition to the recent Juul fiasco, the FDA missed a court-ordered deadline last September to issue decisions on specific e-cigarettes, including Juul. The FDA said earlier this month that it is trying to process around 1 million non-tobacco nicotine products submitted by more than 200 manufacturers.

Last week, FDA Commissioner Robert Califf announced that he had commissioned an external review of the CTP and its food program. The move acknowledged that the agency was stumbling in its regulatory responsibilities. “We have made important progress and reached regulatory decisions on a broad array of millions of products,” Califf said of the CTP. “But even greater challenges lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health.”

https://arstechnica.com/?p=1869888