The US Food and Drug Administration (FDA) tells staff leaving for industry jobs that, despite restrictions on post-employment lobbying, they are still permitted to influence the agency, reveals an investigation by The BMJ today.
Internal emails, obtained under a freedom of information request, show how two FDA officials who worked on covid-19 vaccine approvals were proactively informed by FDA ethics staff about their ability to indirectly lobby the agency as they left for jobs with Moderna.
The record shows that since 2000 every FDA commissioner, the agency’s highest position, has gone on to work for industry.
“So, people will leave government service and can immediately start doing influence peddling and lobbying,” explained Craig Holman, a government affairs lobbyist for the organisation Public Citizen. “They can even run a lobbying campaign, as long as they don’t actually pick up the telephone and make contact with their former officials—and that’s exactly the advice that’s being given here.”
Diana Zuckerman, president of the non-profit National Center for Health Research and a decades long regulatory policy analyst, finds FDA’s proactive provision of advice on behind-the-scenes work particularly troubling. Advice given behind the scenes is precisely “what makes FDA scientists and staff valuable,” she argues.
Peter Lurie, president of the Center for Science in the Public Interest in Washington, DC, and former associate commissioner at the FDA, suspects that FDA ethics staff were simply carrying out their proper function, but he expressed concern over the perils of allowing behind-the-scenes work.
“It does seem contrary to the public interest that an ex-official would be quarterbacking activities behind the scenes, especially for a ‘particular matter’ on which they had worked,” he said. “As a practical matter, this policy likely plays out in a way that advances the interests of big pharma, as that’s where many officials head after FDA.”
The BMJ asked the FDA whether it had any concerns that proactively informing employees about their ability to work behind the scenes could be interpreted as encouraging former FDA staff indirectly to lobby the agency.
An agency spokesperson responded: “No. Working behind the scenes does not necessarily equate to direct or indirect lobbying activities. Lobbying activities are governed by the Lobbying Disclosure Act. Former employees would need to adhere to these requirements, just like any other individual or organization.”
Last month US lawmakers introduced bills to amend the law regulating restrictions on departing employees. They seek to prohibit former health sector employees from serving on the boards of manufacturers of drugs, biological products, or devices after public service. So far, none of the bills have passed.
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Journal
The BMJ
Method of Research
News article
Subject of Research
Not applicable
Article Title
Revolving door: You are free to influence us “behind the scenes,” FDA tells staff leaving for industry jobs
Article Publication Date
1-Jul-2024
COI Statement
Being academically involved in research on various topics of interest to The BMJ, I personally know many authors who submit papers to The BMJ. I try to minimise potential biases by being open and transparent about the potential conflict of interest, seeking advice of others as to the best way to address any potential conflict of interest, and recusing myself from working on certain papers. Being an academic researcher separate to my editorial role at BMJ, I may also submit papers to The BMJ as an author. For such papers, I work to ensure that I am not involved in decision making related to the editorial process. (Past) Between 2011 and 2014 I was funded by the NIHR Health Technology Assessment programme for work on a Cochrane review of neuraminidase inhibitors (http://www.nets.nihr.ac.uk/projects/hta/108001). Works from this project have been published in The BMJ. The NIHR’s funding of this project ended around June 2014. (Past) In 2012, I received €1500 from the European Respiratory Society in support of my travel to the society’s September 2012 annual congress in Vienna, where I gave an invited talk on oseltamivir. (Past and ongoing) I have accepted necessary and reasonable paid-for travel, meals, daily subsistence costs, and accommodation from meeting organisers only when the organisation is a not-for-profit one. As of 2014, this includes the European Respiratory Society, Yale University (YODA), Institute of Medicine, and Drug Information Association. (Past) In 2014, I received a $1000 honorarium, plus meals and hotel accommodation from Des Moines University for an invited lecture on access to clinical trial data. (Past) Between 2015 and 2016, I received $5000 from Johns Hopkins University for my involvement in a PCORI funded research grant to compare data from multiple sources (ME-1303-5785; PI: K. Dickersin). (Past) Between 2015-2019, I received £6305 for my involvement in a Cochrane Methods Innovation Fund grant to produce Interim guidance on the inclusion of clinical study reports and other regulatory documents in Cochrane Reviews. (Past) In 2017, I received a $500 honorarium from the Office of Research Integrity (U.S. Department of Health & Human Services) for speaking on a panel on open science at the Quest conference. (Past) During 2020, I wrote two affidavits (unpaid) for lawsuits in California and Massachusetts that argued against mandatory influenza vaccination for students. Organisational (Past) Since 2017 Between 2017 and 2022, I was the principal investigator of a $1.4 million grant from Arnold Ventures to University of Maryland for my RIAT Support Center, aimed at improving the credibility of clinical trial publications. This funding was for five years and supported my salary at the University of Maryland. (Past) I received a 2015 New Investigator Award from the American Association of Colleges of Pharmacy which provides my university (University of Maryland) with $10,000 to fund a PhD student to work on research on how the potential harms of statins are conveyed in drug labeling and pharmacy leaflets. An additional $1000 supported two PhD students travel to the AACP Annual Meeting. (Ongoing) Since 2014, I have been employed by the University of Maryland (https://faculty.rx.umaryland.edu/pdoshi/) and was previously employed by Johns Hopkins University and Massachusetts Institute of Technology. All three of these are large research universities that have numerous financial relationships with entities that may have an interest in what is published in The BMJ. Unpaid positions (current) (Past) Between 2016 and 2020, I was an unpaid member of the IMEDS steering committee at the Reagan-Udall Foundation for the FDA, which focuses on drug safety.