Picking Apart the Destructive Claim That Industry Controls FDA
I am tired of the continued defamation of FDA as an agency controlled by industry.
That is not to say that FDA is perfect or that there have never been FDA-industry interactions that looked (and maybe were) bad. However, as a generalization….no, FDA is not controlled by industry.
Such allegations are usually based on ignorance or a genuine misunderstanding of how FDA works. Sometimes it is hard to tell, as with recent statements that advisory committees: decide drug approvals (not true)[1], are dominated by industry (not true), and are cleansed in some meaningful way by eliminating the single, non-voting industry member of the committee (not true)[2].
While untrue…allegations of industry-control have consequences. They weaken public acceptance of FDA’s independent, science-based decisions. They endanger the upcoming user fee reauthorization negotiations. They demoralize staff—a significant proportion of whom want lengthy public service and public health careers at FDA and are not looking for industry jobs.
The Resolving Door: An Every Day, Everywhere Phenomena
One of the most often cited examples of industry influence is the so-called “FDA revolving door.” One of my readers even wrote me a note last week, wondering “Isn’t it interesting how many ex-FDA officials wind up in prominent roles within the industry they were charged to provide oversight.”
To which I replied: next jobs are built on current jobs. In both the public and private sectors, employers hire well-qualified people based largely on their career experiences.
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.
There may be a lot of ways a pharmacologist (or a food chemist, or a biostatistician) can make a living, but a significant percentage of those opportunities will be in industry. Does a PhD chemist have to become a car salesperson because otherwise he or she would be perceived as taking advantage of their education, training, and experience to work in or adjacent to FDA regulated industry?
A Self-Fulfilling Prophecy of Alleged Industry Influence
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].”
Why shouldn’t they hire him: no one else will have a better understanding of what FDA will require for approval of their product. The company will still have to prove the product is safe and effective and can be supplied at scale to the market using current good manufacturing practices and after an inspection.
FDA Is Not So Easy to Influence
The supposed revolving door is not the only argument you hear. Each and every medical and food decision that appears to favor industry seems to be fair game for the accusation that influence was involved.
Let me repeat my caveat here: I am not saying that FDA is perfect or that there have never been FDA-industry interactions that looked (and maybe were) bad. However, as a generalization….no, FDA is not controlled by industry.
At least on the medical products review side, FDA decisionmaking has three characteristics: it is bottom-up; it is multi-disciplinary; and no one has authority to make non-routine final decisions except the center directors.
As a result, lots of FDA staff have the opportunity to have their say about recommended actions as they make their way up the chain. Plus, if there is continued contention, there is often an internal review that includes senior staff not previously involved. In addition, the decisionmaking process often includes a public advisory committee meeting, with independent experts.
No one can make a decision at FDA that hasn’t been scrutinized by at least a few people and, in most cases, by many people. There is no secret or unilateral decision making[3]. There is really not much opportunity to influence FDA (no less control it) that dozens of people would not know about.
FDA cannot delegate drug approvals to a non-governmental entity or person, even if it wanted to.
Applying Chesterton’s Fence to Industry Representatives on FDA Advisory Committees. Third item at: https://www.fdamatters.com/fdamatters/how-many-people-still-work-for-fda-amp-other-fda-thoughts
There are a few well-publicized examples of center directors overruling senior staff on efficacy issues (not safety), but the issues involved were well-aired publicly both before and after the decision was made. https://www.fiercebiotech.com/biotech/fdas-marks-i-contradict-fda-reviewers-trepidation