Political Interference at FDA Is Under-Reported: GAO
(Thursday, April 21, 2022)
A Government Accountability Office (GAO) investigation found that FDA officials did not report potential political interference to influence their decisions due to lack of a formal process for the same or for fear of retaliation. The GAO recommended that FDA, CDC, and NIH should develop formal procedures for training personnel in reporting allegations of political interference in scientific decision-making. Political interference is a loose term that describes any untoward interaction between FDA and politicians trying to influence a regulatory decision. Most such interactions likely happen during a dispute between the regulators and companies. The FDA processes for dispute resolution take long time, are opaque, and often accused of unfair mediation. Company unhappy with FDA’s dispute resolution process often approach their political representatives for assistance which could mean a contact to FDA by them on behalf of the grieving party. Not all such contacts are illegal and not all contacts could be considered as interference. Having an outside party mediate could help both FDA and the company appreciate the process better and lead to amicable resolutions. There is no public evidence that FDA has made product approval decisions solely based on political interference, although the last administration was frequently accused of trying to strong arm FDA, CDA, NIH and Department of Health of Human Services (DHHS) officials to make decisions they were not comfortable with. The GAO report does not list any cases where political interference led to a decision that would not have happened otherwise. The GAO report states the obvious; that there be a formal process to air allegations of political interference at FDA, and the agencies agree with it. No controversies here, everyone agrees. But is that how it would read?
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC