The Revolving Door Turns a Full 360 degrees with Califf: Why Should We Care?
(Thursday, November 18, 2021)
Does it matter that the FDA’s top leader has cozy relationships with the industry he regulates? Would it influence the policies he proposes, and would those policies still give patient and public interest the same weight as that of the for-profit industry? These are reasonable questions to ask when anyone takes on any role at FDA. And these are not new questions. FDA deals with the revolving door syndrome where its former employees work for the same companies they regulated during their tenure at the Agency, and some time those employees come back to work again at FDA, and then going leaving second time for another stint at similar companies, a revolving door that creates the perception of cronyism and bias. This happens at all levels of FDA’s organization and generally it is does not get much media attention. Dr. Califf’s nomination to head the FDA once again is such an event. Should the public care? The answer is far from a clear black and white. The pros of someone with industry experience coming to the FDA is the familiarity this person would have with the inner workings of the industry which should help him/her have a more balanced perspective when creating and enforcing government policies. The con is that since this same person was or will be planning to create profit making decisions for the companies, there is an obvious bias. Afterall this person would not want to hurt his/her chances of going back to the industry after the stint at FDA. The job at FDA involves making judgement calls on products, many of which are hard to explain to outside parties. Tt would feed the perception of bias by the parties at both the favorable and unfavorable ends of that decision. Apart from the perception, it would make it very hard for the person to do the job he/she is hired to do at FDA if every decision is suspect. In an ideal world, public officials would be barred from working for the companies they regulated at least for a reasonable period after leaving the government. But that is impractical and would be mostly illegal under the current regulations. The checks and balances in the system do little to change the public perception. Being a revolving door for experts who use their stints at the FDA to get lucrative jobs once they leave the Agency is a dark reality. An average citizen has little say in who leads the FDA. A much better option would have been a career regulator with a demonstrated track record of unbiased opinions which someone who worked at the industry cannot claim. But it seems there is little political will to bring such people at the helm of the most important government agency for healthcare in the country, and probably the world.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC