With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, there could be a wealth of talent available to biopharma companies. Does this pose an ethical quandary? It depends on who you ask.
It’s a tenuous time to be a U.S. government employee. Outgoing CBER Director Peter Marks learned this last week, as did the 10,000 employees at the U.S. Department of Health and Human Services axed by new Secretary Robert F. Kennedy Jr. Given all this tumult, one might not blame staffers—including ex-CDER boss Patrizia Cavazzoni—for wanting out.
“Given all that is going on with the transition to the new administration, it feels a bit unfair to publicly criticize any federal employees leaving FDA and going to the private sector,” Joseph Ross, a professor of medicine and public health at the Yale School of Medicine, told BioSpace in an email. However, due to potential conflicts of interest, “the revolving door between government and industry has long been a concern, particularly among the higher level, more senior officials,” he added.
Over the past few years, several higher-ups at the agency have found their way back to industry roles. Cavazzoni left her post as the director of the FDA’s Center for Drug Evaluation and Research (CDER) on Jan. 18, two days before Donald Trump was sworn in again as president. A month later, Cavazzoni returned to her old stomping grounds as chief medical officer at Pfizer, where she previously led clinical sciences and development operations in multiple senior roles.
Former FDA Neuroscience Director Billy Dunn followed a similar path, joining the board of biotech Prothena Biosciences in May 2023, three months after leaving the agency. Four years earlier, in May 2019, ex-FDA Commissioner Scott Gottlieb returned to his former venture capital firm New Enterprise Associates less than two months after leaving his FDA post and joined Pfizer’s board the following month.
The reverse pattern is also true. Two-time FDA commissioner Robert Califf was reportedly paid $2.7 million by Alphabet-owned Verily Life Sciences for advisory services before starting his second term at the agency in 2022.
A 2016 article showed just how pervasive the cross-over is, with more than half of the hematology-oncology assessors who reviewed drugs at the FDA between 2001 and 2010 later moving to industry. One concern is that an FDA employee will make decisions in favor of the pharmaceutical industry and use that to secure a “much higher paying job” within the industry, explained Peter Pitts, former associate commissioner for external relations at the FDA and current president and co-founder of the Center for Medicine in the Public Interest. But he called this a “misperception.”
“Headline: it’s not a problem,” Pitts told BioSpace. “I have never met a single person who had worked at the FDA and went and got a job outside of FDA that tried to parlay that job through their actions while they were in government service. Zero.”
Still, not everyone is as confident. “One thing we might be worried about is that officials, prior to leaving or looking to leave, are influenced in their decision making in ways that are favorable to firms as they’re looking to exit to,” Genevieve Kanter, an associate professor of public policy at the University of Southern California Price School of Public Policy, told BioSpace. Moreover, after landing in their industry position, they could potentially exert influence on a regulatory decision through their relationships with people still at the FDA.
“It doesn’t have to be problematic when a senior level official leaves to go to industry,” Kanter emphasized, but it is important to ensure that as the door turns, we are “preserving the integrity of agency decision making.”
The Debate
Even without directly leveraging a connection with former colleagues, there are notable benefits for Pfizer to having the former CDER director as CMO, Kanter said of Cavazzoni’s recent move. “I’m sure she has some inside information on the approach that the agency is taking on specific maybe Pfizer products, insight into [FDA’s] thinking about particular classes of products that might be more promising that might help in Pfizer’s strategy,” she said, adding that Cavazzoni could also have insight into potential barriers to approval.
In Pfizer’s announcement of Cavazzoni as CMO, the company touted her experience in “clinical development, pharmacovigilance, clinical operations, regulatory affairs, safety risk management, epidemiology and R&D strategy.” Pfizer did not respond to BioSpace’s request for comment.
Pitts argued that public health could benefit from industry employing former FDA officials “because they help them do a better job. They help them understand what the regulations mean. They help them understand kind of where the philosophical underpinnings of drug regulation are moving to.”
In 2018, Science found that 11 of 16 ex-FDA medical examiners who worked on 28 drug approvals were currently employed by or consulting for companies they recently regulated, a phenomenon the publication said could create at least the appearance of conflicts of interest.
This concern can be highlighted by a few notable cases, including that of Joan Buenconsejo, who led the FDA’s analysis of medical statistics for AstraZeneca drugs and later joined the company as a director, and Jeffrey Siegel, who oversaw the FDA’s approval of Genentech’s arthritis drug Actemra and was later hired as the global head of Rheumatology and Rare Diseases.
When it comes to managing conflicts of interest, there are preventive safeguards in place, including two federal statutes.
An FDA Post Employment Restrictions Document references criminal conflict of interest statute, 18 U.S.C. § 208, which “prohibits an employee from participating personally and substantially, in an official capacity, in any ‘particular matter’ that, to the employee’s knowledge, would have a direct and predictable effect on the employee’s financial interests or on the financial interests of a person or organization with whom the employee is negotiating or has an arrangement concerning prospective employment.”
On the flip side, another statute, 18 U.S. Code § 207, imposes “restrictions on lobbying back to your former agency,” on any particular policy matter on which an employee has been involved, Richard Painter, former chief ethics lawyer for President George W. Bush and current professor at the University of Minnesota, told BioSpace. In the pharma industry, this could be a drug license or application.
For former senior FDA officials, the statute goes even further. “They have a ban for one year of lobbying back to the [FDA], on anything, any matter whatsoever,” Painter said. “So as long as you follow those rules, people have a lot of latitude.”
While exiting FDA employees are supposed to recuse themselves from matters affecting their eventual new employer, this rule may only work if the FDA official has a target destination in mind, Kanter said. “If they’re looking around, that’s the kind of rule that’s very difficult to enforce so it’s difficult for outsiders, for the public to know in real time what products might be affected.”
Also, Kanter said, FDA staffers are expected to disclose a new role to their supervisor. But this can pose a catch-22 situation “because you may not want your boss to know that you’re planning on leaving.”
The Trump Effect
As part of the recent HHS job cuts, the FDA will reportedly lose 3,500 staffers, a situation Kanter expects to contribute to an exodus of FDA staff to industry. “With the downsizing of the government along many different sectors . . . there’ll be fewer opportunities to jump to another federal position,” she said. “So I expect even more people will go to industry because of what’s happening with [the Department of Government Efficiency].”
One recent example of this is Peter Stein, director of the Center for Drug Evaluation and Research’s Office of New Drugs, who got caught up in the latest round of FDA cuts. Stein was offered a “reassignment” in patient affairs, according to Endpoints News. He turned it down, calling the offer “ridiculous,” Endpoints reported.
For Pitts, it’s a matter of fait accompli. “More people are leaving FDA now because they’re being [let go]. So unless . . . there’s a post-FDA training program that the government’s going to pay for, people will get jobs where they are capable and have something to offer.” Namely, in the biopharma industry.
But once again, Pitts questioned whether this is really an issue. “Are we trying to solve a problem that doesn’t exist?”
