FDA and the Revolving Door: Much Ado About Nothing?
The announcement that former CBER Director, Dr. Peter Marks, was joining Lilly as SVP for molecule discovery and head of infectious diseases....set the internet ablaze with unjustified outrage about his transition from a government career to industry. My multiple comments and responses on LinkedIn (e.g. here) received nearly 20,000 impressions in total:
“There are numerous crazy posts on LinkedIn about the revolving door. Where is Dr. Marks supposed to take his education and experience other than a place where he can continue to advance medical science and patient care? Should he become a used car salesman to satisfy some people's fevered imagination that something wrong has occurred?”
Below are questions asked by subscribers to FDA Matters (www.fdamatters.com) and others.
Q: Peter Marks would have had many attractive post-FDA opportunities besides pharma. Why choose the one he did?
A: Many people seem to have the same view: Dr. Marks should have gone to work for a non-profit or done clinical research next. In short, he should work anywhere other than a profit-making biopharmaceutical company. But why should he limit his job opportunities to accommodate the ill-informed and prejudicial assumptions of other people?
His passion — and his most significant contribution to society — has been his commitment to the well-being of patients and his role in facilitating the development of safer and more effective therapies, especially for those with rare diseases. If he cannot be doing that at FDA, what better place than at one of the world’s largest drug discovery organizations, with the budget and mandate to make a difference?
Dr. Marks is representative of the larger FDA workforce — hardworking, committed, well-paid (but less so than in industry), and hoping to make public service at FDA their career. When that doesn’t work out (e.g., DOGE layoffs), they look for other opportunities to continue doing public-spirited work (such as making food safer or contributing to the development of better drugs and devices) within a non-governmental, often for-profit, setting.
One FDA Matters subscriber sent me this: “[It is] disheartening to see the disconnect and misinformation of these [negative] posts... if the author only just put in a little effort and spoke to rare disease advocates and parents, she would get a better understanding of what Dr Marks represents. Great to see him continue to care and give.”
Q: Is Dr. Marks working for a drug company an example of industry controlling FDA?
A: In my May column, entitled “Picking Apart the Destructive Claim that Industry Controls FDA,” I addressed this question of industry control and responded with a resounding “no.” Recently, a subscriber wrote: “If industry did control FDA, I would be out of work as an FDA enforcement defense attorney [defending companies in trouble with FDA], and I’m not! You’re right, it is a preposterous claim.”
There is a caveat that accompanies all my writings about FDA/industry relationships: “I am not saying that FDA is perfect or that there have never been FDA-industry interactions that looked (and maybe were) bad. However, FDA is not controlled by industry.” I stand by that.
Q: Why do so many FDA employees work in regulated industries after they leave FDA?
A: There is nothing nefarious—or even out of the ordinary—that people leaving FDA wind up working in regulated industries. That’s where the bulk of the opportunities will be for them. It’s also where people with their credentials — with or without FDA experience — are most likely to be valued.
An individual’s next job is usually built upon expertise from their current job. Employers hire well-qualified individuals primarily based on their career experience. That is true whether an employer is hiring a mechanic, a manager, a salesman, an accountant, or a specialist who worked at FDA.
Q: Do you expect more stories about FDA staff moving to industry?
A: Yes. Not only do I expect it, but I also predicted it would happen. In a column in May (here), I wrote:
“The DOGE initiative was responsible for the RIF of 3,500 FDA employees. Incentives and lay-offs were used to drive an unknown number of others to leave FDA.
The bulk of these people had made their careers at FDA or were planning to do so. They were not looking for industry jobs but are being forced to do so now.
DOGE has created a self-fulfilling prophecy of FDA employees going to work for industry. By Fall, I envision stories that will feed the defamation of FDA: “John Smith, formerly FDA division director for X, now works at [insert name of company with interests in developing X-type products].”
Defamation of FDA and its employees is harmful, even though it is predictable.
Q: Are FDA employees allowed to own stock in companies they regulate?
A: No. There are explicit restrictions that prevent stock ownership in regulated industries. Here are the key features:
“The HHS Supplemental Regulations prohibit employees of the Food and Drug Administration, or the spouse or minor child of the employee, from holding a financial interest (e.g., a stock holding) in any FDA "significantly regulated organization."
“Significantly regulated organization" is defined as an organization 1/ for which the sales of products regulated by the FDA constitute ten percent or more of annual gross sales in the organization’s previous fiscal year; 2/ where an organization does not have a record of sales of FDA-regulated products, it will be deemed to be significantly regulated if its operations are predominately in fields regulated by FDA, or 3/if its research, development, or other business activities are reasonably expected to result in the development of products that are regulated by FDA.” (Emphasis and numbering added).
The fact sheet describing the rules is here.
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