FDA’s Internal Processes for Handling Whistleblower Complaints Unmasked
(Thursday, April 1, 2021)
Complaints by whistleblowers do not lead to automatic investigations by FDA and could take years for FDA to find credence. Many a times we know about whistleblower complaints to FDA that seemingly do not go anywhere as the alleged violators continue without any FDA investigations or negative consequences. There is no simple answers as to why FDA would not taken strict action but every whistleblower should know certain facts about the FDA process before embarking on a risky journey of filing such complaints to FDA about their employers. An investigation by the Office of Special Counsel (OSC) investigating the mishandling of a confidential whistleblower compliant unmasks several issues with how FDA handles such complaints. The case in point discussed a whistleblower (called confidential informant or CI) compliant to FDA, initially made in 2016, where the complainant listed egregious violations of clean room practices at a vaccine manufacturing plant owned by Merck Sharp and Dohme in North Carolina. Upon receipt of such a compliant, it could take months before FDA can put together resources to investigate. Upon the initial complaint received in Jan 2016, the FDA inspectors audited the facility in November 2016, almost 11 months later. They did not find any major violations and the case was apparently closed since there were no actions taken by the FDA. The whistleblower/CI complained again on 13 September 2018. This time, it seems the facility inspection was already scheduled for 22-30 Oct 2018 (about 6 weeks later) but the visiting inspector was not provided the findings in the complaint till the inspection had already begun. The FDA inspector contacted the CI, who shared the same information included in his/her complaint to the FDA, but the inspector could not directly observe those violations since the company had apparently (according to the CI) already removed all the evidence. The inspector obviously believed the CI more than the FDA staff located at the headquarters. The staff at the FDA headquarters did not agree with their inspector’s pleas to escalate the matter citing lack of direct evidence. So, the whistleblower, who apparently risked his/her job to inform FDA of violations at his/her employer, is probably not happy, neither is the FDA inspector (now former FDA inspector). But the facility is still operational and apparently very active in Covid vaccine manufacture.  This case is a classical case of he said – she said, where FDA did not want to pursue punitive action without direct evidence, and the complainant felt like his/her complaints were unheard. Either way, the process is not as simple as it may seem to give the violators seemingly many opportunities to escape FDA actions.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: mkumar@fdamap.com
​ Linkedin: Mukesh Kumar, PhD, RAC
 Instagram: mukeshkumarrac 
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