Top FDA tobacco official resigns to take job at Philip Morris International

OOn July 26, Matthew Holman, director of the Food and Drug Administration’s Center for Tobacco Products (CTP) Science Office, told staff that he would be leaving for an undisclosed position at Philip Morris International (PMI). .

Brian King, who became CTP director in early July, wrote in a letter to colleagues that Holman would leave “immediately”, revealing that the former OS chief “has been on furlough since the start of my tenure at the Center and saying that “he recused himself, in accordance with agency ethics policies, from any CTP/FDA work while exploring career opportunities outside of government.”

“The FDA thanks Dr. Holman for his federal service and wishes him well,” an agency spokesperson said in a statement to Filtered. “The work of the Center for Tobacco Products‘ Office of Science is critical to our mission to protect Americans from tobacco-related illness and death. We are confident in the expertise and ability of our staff to continue this essential public health work as the Tobacco Products Center conducts a nationwide search to identify the next Director of the Office of Science.

King added in his internal memo that Dr. Benjamin Apelberg and Dr. Todd Cecil, two OS superiors, would serve as acting OS directors on a rotational basis until a permanent leader is found. (Cecil will start.)

The announcement surprised much of the world and the tobacco control industry, and speculation arose about the details of Holman’s new role and the start of conversations between him and PMI. A PMI spokesperson said details of Holman’s job responsibilities would be shared at a later date.

“Dr. Holman doesn’t leave the FDA, he escapes.

The timing, however, seemed fortuitous, as the CTP – an entity already often maligned in tobacco harm reduction circles – seemed to be hitting walls ever harder. Earlier this month, Robert Califf, the FDA commissioner, said he was ordering outside experts to assess the CTP, shortly after the agency essentially reversed its denial of the order. marketer of Juul and has faced endless calls from lawmakers to regulate synthetic nicotine.which only recently came under its regulatory authority.

Continuing its piecemeal attempt to institute a “comprehensive” tobacco control plan for the future, the FDA is also now weigh a ban on combustible menthol cigarettes and continue plans to reduce nicotine levels in cigarettes to virtually zero.

“Dr. Holman doesn’t quit the FDA, he escapes,” said Amanda Wheeler, president of American Vapor Manufacturers and owner of an Arizona vape store. Filtered. “It’s hard to avoid the feeling that the most serious and essential work on tobacco harm reduction is being done outside of an agency that seems beyond repair.”

As the accusations of misunderstanding behaviour started circulating onlinea source with deep knowledge of the development said Filtered who speaks to Holman, a well-liked and respected scientist, began talks with PMI in early July – and after he had recused himself from his duties at the FDA.

At least one journalist Noted that Holman had signed one of PMI’s Modified Risk Tobacco Product Applications (MRTPA) for its heated tobacco product IQOS in March 2022; it should be noted, however, that the MRTPA did not grant PMI a “risk modification order”, which would have allowed the company to make marketing claims that the product reduces the risk of, say, certain diseases, and instead received an “exposure modification” command, which only allows a handle authorized exposure claims.

In a space riddled with bureaucracy, these distinctions are significant. It’s easy to draw comparisons to the deceased FDA director who approved Purdue’s OxyContin, then quickly went to work for Purdue for a $400,000 salary. But Holman wasn’t sitting at his desk, for example, running premarket tobacco product applications (PMTAs) through the licensing process. In fact, the opposite is true: Holman has greenlit millions of marketing denial orders to countless steam companies, and even some of the biggest players haven’t been spared.

Holman’s departure is emblematic of a broader shift.

“Dr. Holman has dedicated a significant portion of his career to scientific and policy issues aimed at improving public health,” a PMI spokesperson said in a statement. Filtered. “He is committed to helping current adult smokers access scientifically proven smoke-free alternatives while protecting young people. We look forward to him joining our team as we continue our quest for a smoke-free future.

Holman’s departure is emblematic of a broader shift. Scientists, engineers and policymakers are increasingly willing to leapfrog to Big Tobacco, as these demonized companies, with their cynical tales of deception around the harms of cigarettes, move towards safer nicotine alternatives. like vapes. (In May, Kegan Lenihan, a former FDA chief of staff, joined PMI to become vice president of government affairs and public policy, and chief of its DC office.)

Holman, who spoke on panels at the E-Cigarette Summit, has always appeared to support the FDA’s “risk continuum” strategy, which was frequently touted, if not widely followed, by the former commissioner of the agency, Scott Gottlieb. It’s the idea that some nicotine products – like e-cigarettes, heated tobacco devices and oral tobacco – are less harmful than combustible cigarettes and that adult smokers should be encouraged to switch if they don’t. are unable or unwilling to quit smoking.

“This is very good news and a bold move inspired by Holman,” said Clive Bates, the former director of Action on Smoking and Health (ASH) UK. Filtered. “He has always been someone who tries to do the right thing and act with integrity, albeit within the confines of the FDA and tobacco control law.”

Bates and others grilled Holman at the latest e-cigarette summit in May, where Holman hotly challenged the critics, citing the legal restrictions he and his FDA colleagues were working under.

“This decision sends a massive signal in favor of harm reduction by recognizing that tobacco companies will be the primary drivers of the endgame of smoking,” Bates continued. “Holman is the most prominent regulatory professional to understand and endorse this reality. It won’t do anything about combustible products other than working day and night to phase them out with much safer alternatives. He is susceptible to attack by anti-tobacco activists, but what he is doing is ethical and based on credible public health grounds.

Some in tobacco control and within the industry, all of whom requested anonymity so as not to harm their careers, suggested Filtered who Holman might have been aiming to be the new CTP director, a position left vacant when Mitch Zeller retired in April. The job eventually went to Brian King, formerly of the Centers for Disease Control and Prevention’s (CDC) Office on Smoking and Health (OSH), who has been repeatedly criticized for not correcting the record on “EVALI.” .

Others also wondered if Holman was growing increasingly disillusioned with the agency, which has seen his plans explode countless times by trigger-happy lawmakers pounding the drum the so-called “epidemic” of youth vaping.

Holman did not respond to Filteredrequest for comment. Zeller declined to comment via email.

The PMI spokesperson also said Filtered in a statement that “Dr. Holman will abide by all post-employment restrictions.

Holman’s intimate knowledge of CTP is likely to be a goldmine for PMI as it navigates regulatory challenges.

“These restrictions prohibit Dr. Holman from appearing before or communicating with the FDA on PMI’s behalf regarding any matter for a period of one year,” the statement continued. “Further, Dr. Holman is prohibited for a period of two years from appearing before or communicating with the FDA on behalf of PMI regarding any pending matters under his official responsibility during his final year of government service. . Finally, Dr. Holman is permanently prohibited from appearing before or communicating with the FDA on behalf of PMI regarding any particular matter in which he has been personally and substantially involved during his entire term of government service.

However, speculation has been circulating that PMI will soon be filing a number of PMTAs and trying to make a splash in the US: recently, PMI and Kavial Brands entered into an international license agreement which will allow PMI to “manufacture, sell and distribute the Bidi Stick” – a disposable vaping product – in markets outside the United States, and another PMI-owned e-cigarette, Veev, has already been launched in select markets around the world. GPA also reaches an agreement to buy Swedish Match as well.

Holman’s intimate knowledge of CTP is likely to be a goldmine for the company as it navigates these regulatory challenges.

“PMI says it’s making a fundamental shift toward far less dangerous products,” said David Sweanor, tobacco industry expert and chair of the advisory board of the Center for Health, Law and Research. , politics and ethics of the University of Ottawa. Told Filtered. “If it’s a sincere effort, Holman can facilitate change that has enormous public health benefits. If it’s not sincere, people like Holman are in a very good position to get over it. account and potentially call the company out on its irresponsibility. Either way, public health goals can be advanced.

Screenshot of the E-Cigarette Summit stream showing, from left, Matthew Holman, Clive Bates, Marc Slis and Professor Kathleen Hoke

The Influence Foundation, which operates Filteredhas received grants from PMI and Juul Labs, Inc. FilteredThe Editorial Independence Policy applies.

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