The departure of the head of the Food and Drug Administration’s tobacco science office for a job in the tobacco industry shines a new spotlight on a long-running problem: the “revolving door” between government regulators and the industries they police.
Matt Holman, whose work at the FDA influenced decisions around the safety of products such as e-cigarettes, left the agency Tuesday for a job with Philip Morris International, whose products — sold overseas — include Marlboro cigarettes and the electronic tobacco-delivery system IQOS.
Agency watchdogs say where there is smoke, there’s an ethics fire. They’ve warned of revolving-door concerns — only well-documented for high-level positions and for the Defense Department — for decades. But there is little hard data on just how big the problem is. A Grid analysis of LinkedIn profile data suggests that at least 2,700 ex-FDA employees now work for the pharmaceutical industry. Another 1,100 current FDA employees have moved the other way, from industry to the agency, according to the profile information.
Former FDA employees are found throughout many other industries regulated by the agency as well: Around 1,200 now work in the biotechnology industry, and more than 600 work in the medical devices industry. Some of the most high-profile examples include Trump FDA chief Scott Gottlieb, on the board of directors of Pfizer weeks after he left the job, as well as the current commissioner, Robert Califf, who went from heading FDA during the Obama administration to Alphabet Inc.’s health subsidiaries, and then back to heading the agency this year. Califf pledged not to work for a pharmaceutical or medical device firm for four years after leaving his current post to win the Senate votes he needed for his confirmation.
In a July 26 memo announcing Holman’s departure, newly installed FDA Center for Tobacco Products Director Brian King said that Holman had recused himself from tobacco-related regulatory decision-making and been on leave before July. “I’m grateful to Matt for his contributions to the Center and unwavering commitment to you all over the years,” said King.
The numbers are both interesting and not surprising, said Michael Carome of Public Citizen, a public health watchdog group based in Washington, D.C. The count likely underestimates the number of agency employees who have jumped to the industries they once regulated, he added, and obviously doesn’t include industry figures who have moved to the agency, where they briefly stay before returning to their home industry, another area of concern for ethics experts.
“Unfortunately, when you see somebody go from a regulating agency to the regulated industry, the public is naturally going to react like it’s a betrayal, because it does call into question your commitment to the mission of protecting the public,” said government ethics expert Walter Shaub of the Project on Government Oversight. While regulated companies may honestly want the expertise of the people charged with regulating them, said Shaub, “the other thing is that they want to know the inside workings of the FDA.”
“They want to, or one might suspect they want to, create an atmosphere in which employees at FDA know that there’s a lucrative job waiting for them, potentially, as long as they don’t really upset the regulated industry, right? I just think that’s human nature,” he added.
Revolving-door concerns rise and fall with news of moves like Holman’s, said Carome. Concerns also were high during the Trump administration, when both Cabinet officials and the president faced ethics complaints about their business links. “There is just a real lack of data out there on how bad things are at the agency employee level,” Carome added.
LinkedIn data includes 645 million people and 56 million companies, but has limitations, said Dorothy Norris-Tirrell, chief learning officer of the Nonprofit Leadership Alliance, whose own research uses LinkedIn to investigate career paths at nonprofits. Chiefly, the data is self-reported by users rather than verified and is not updated. However, the data could be taken to point at trends, she suggested, and it would be interesting to stratify the listings by when people moved from the FDA to the industry, their job positions and the length of their tenure at the agency beforehand. (For perspective on LinkedIn’s comprehensiveness, it lists about 16,000 people as working for FDA right now, which is almost 90 percent of the agency’s full-time workforce.)
Regarding Holman, Philip Morris International said the former FDA official “is committed to helping existing adult smokers access scientifically substantiated smoke-free alternatives while protecting youth,” in a statement sent to Grid.
Holman is barred from communicating with the FDA about Philip Morris for a year, under ethics rules, and about any matter he was personally involved with at the agency for life. In comments to the New York Times, Holman defended his move, noting that he consulted with agency ethics lawyers and viewed Philip Morris International as moving away from cigarettes to less harmful tobacco products, saying he could have jumped to the industry much earlier after 20 years at the FDA if that had been his goal. (He has not yet responded to a request for comment from Grid.)
However, numerous regulatory affairs or drug development employees at FDA-regulated pharmaceutical companies, including Merck, Abbott and Johnson & Johnson, worked at the FDA for more than a decade prior to moving to the industry, according to the LinkedIn data. “The idea that they recuse themselves is really BS, because they are telling the companies how to manipulate the system behind the scenes,” said Diana Zuckerman, president of the National Center for Health Research, herself a former Department of Health and Human Services employee.
Holman’s departure comes as the Biden administration has turned up the heat on the tobacco industry, planning to require slashing nicotine in cigarettes to minimally addictive levels, and moving to prohibit menthol cigarettes. A 2016 law has led to a crackdown on e-cigarettes, threatening small vaping shops and leading to a lawsuit with Juul after the agency last month ordered the e-cigarette maker to halt sales, despite allowing tobacco giant RJR to sell its own e-cigarettes. The agency’s tobacco and food safety programs are now under external review after the recent infant formula shortage and a surge in teens vaping nicotine since 2017.
“There have been a lot of strange decisions coming out of that office,” said Stanton Glantz, founding director of the UCSF Center for Tobacco Control Research and Education, a longtime tobacco industry critic, referring to the Center for Tobacco Products.
Like other tobacco companies, Philip Morris International has moved to “noncombustible” tobacco and vaping devices, part of its bid to expand beyond cigarette sales. On March 11, Holman signed a “modified risk order” from the FDA to Philip Morris authorizing the company to market its heated tobacco products using language saying that such a product “significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”
“He seems more sympathetic to Philip Morris’s language on tobacco than a public health official should be,” said Glantz. (Sales of Philip Morris heated tobacco products are on hold in the U.S., part of a global patent fight with its rival, RJR, marked by mutual claims of infringement.)
While federal ethics laws require the narrow recusal of former agency officials from communicating with regulators about matters they personally worked on, the rules don’t exclude issues their colleagues or subordinates worked on, said Shaub. The laws also lack teeth beyond protecting trade secrets or classified information: “The penalty is you might be fired from your government job, which is not much of a threat to someone who has left an agency.” While obviously not every FDA employee can or should be barred from working for a regulated industry, Shaub called for toughening the rules for people in the most pivotal roles, those making decisions about permitting lucrative products —including tobacco, still the leading preventable cause of death in the U.S. — that may harm the public.
The Biden administration attempted to address the revolving-door phenomenon last year by ordering its appointees to pledge to not work on matters they oversaw at an agency for two years after they left their position, and to not help others lobby on those positions for one year. Sen. Elizabeth Warren, D-Mass., has questioned tax-preparers over the hiring of Treasury and IRS officials, co-sponsoring an Anti-Corruption and Public Integrity Act during the Trump administration meant to curb use of the revolving door by high-ranking officials.
“There are certain really sensitive positions, involving national security or public safety, that ought to be considered out of bounds for this kind of revolving door,” said Shaub. “And the FDA certainly is on the front line of public safety.”
Thanks to Dave Tepps for copy editing this article.