Last week, several news outlets wrote articles about the “revolving door” at the United States Food and Drug Administration (FDA), stemming from a research letter published in the BMJ. The bulk of the articles excoriated FDA employees who leave the FDA to go work for private companies in the pharmaceutical industry.
The original research letter, authored by researchers Vinay Prasad and Jeffrey Bien of Oregon Health and Science University, found that nearly sixty percent of medical reviewers who left the FDA went on to work for, or consult with, the pharmaceutical industry. Prasad found the estimated figures astounding, “when you know 60 percent of your colleagues who leave go to work for the industry, it may make you more likely to be the kind of regulator that gets along well with the industry, helps them shepherd drugs through, and doesn’t push too hard on the warts in a trial.”
It is important to note that the research done by Prasad and Bien only included fifty-five FDA reviewers who had worked in the FDA’s oncology products division. Of those 55 reviewers, 27% went to industry, 2% went to academia, 8% continued working for the government or doing related consulting, and 14% could not be found. Forty-nine percent continued to work for the FDA.
Prasad and Bien recognized that the “transition from regulator to advising companies seems logical, but it raises concern as to whether regulators indefatigably act in the public interest.”
The New York Times dubbed the revolving door kin to “appointing the fox to guard the henhouse” and asked for “Congress to enact conflict-of-interest laws forcing employees above a certain grade level at any agency to recuse themselves from official actions that affect a former employer or client, including trade associations and their members.”
Is The Revolving Door Really That Bad?
While the revolving door may be a fair topic to study, having former FDA officials on the pharmaceutical industry payroll can have a true public health benefit. Former FDA employees with a deep working knowledge of the approval process can help make it go smoother by ensuring all relevant research is complete and that the latest pathways to approval are understood.
The FDA process can be Byzantine at times and having access to someone who previously worked at the FDA, now working in private practice to help guide applications can help avoid many serious errors in the application. Such expertise can lead to an early approval, saving considerable time and effort for both the companies and FDA by preventing submissions of product that have little chance of approval.
Similarly, why do football players become football coaches? Because they understand the game. The same holds true for scientists who worked at FDA as reviewers and now work for industry, they understand the game. The reason for this is the same for drug development as it is for football, if a company spends billions to develop a breakthrough therapy, the company may need some help understanding the nuances of the FDA submission process. This cuts both ways, first it helps companies with reasonably good therapies to get through the gauntlet of the FDA, second, it helps companies face reality, that perhaps their “drug” or “baby” may not be as good as they had lead themselves to believe. In either scenario, the usefulness of someone who has been on the other side of the table and understands their perspective is invaluable.
You can also look at district attorneys and their staff. More likely than not, if a study was done with respect to where they go after a few hours of working for the public, it would show that a vast majority end up working for legal defense firms, making several times their DA salary. Just because they switched from public to private, or from one side to the other, does not innately make them biased.
Dr. Joshua Sharfstein, a prior FDA principal deputy commissioner, disagreed with the critics, noting that “there are just so many checks and balances within the review process that it’s really not up to one person by and large. Key regulatory decisions are looked at from many different angles. I think it would be very difficult for an individual to do something inappropriate and not have that caught.”
Additionally, the FDA has a strong set of rules in place to ensure that its employees are working in the public interest, not to advantage any company, organization or individual. Some of the rules include protecting confidential information they learned at the FDA and a cooling-off period for senior officials.
Andrew Powaleny, a spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA), noted that “expertise in drug discovery, development and regulatory affairs gleaned from both government and the private sector experience can enhance shared knowledge. This knowledge can better inform scientific and medical research and enhance predictability for the benefit of patients.”