FDA Makes it Easy for Whistleblowers to Report Misconduct by Medical Device Companies  
​[Posted on: Thursday, October 27, 2016]

This week FDA released a new form specifically designed for whistleblowers in the medical device industry. Anyone can report alleged regulatory misconduct directly to FDA. The kind of misconduct FDA is looking for are failure to register and list a medical device, marketing uncleared or unapproved products, failure to follow GMP, or off-label promotion. The examples cited by FDA are common complaints observed in Warning Letters to medical device companies. The form can be submitted online at FDA’s web-site, emailed to FDA or printed and mailed to the Office of Compliance. Whistleblowers are asked to attach supporting information and contact information to help the FDA investigation but promises to investigate even if such information is not provided or when the submitter chooses to submit a report anonymously. Like all whistleblowers, FDA will not share the identity or contact information with anyone outside the FDA. While the information solicited by FDA is not new or surprising, the form itself is unique since no other such formal format exists for whistleblowers. It is not clear from the announcement what triggered FDA to create such a form specifically for medical devices as events of misconduct are not limited to medical devices. Whistleblowers are common informants for FDA and have been instrumental in many big-ticket penalties and other regulatory actions against all categories of FDA-regulated companies. A newspaper investigation last week had claimed to unearth seemingly dubious practice of delayed reporting of adverse events linked to medical devices, and some have argued that to be the trigger for FDA to create such a form but that seems unlikely. First the time between the news article and the release of the form and the FDA announcement is too short for such a major regulatory action to occur at FDA. Second, delayed adverse event reporting is one of the several misconducts solicited by FDA. Third, FDA did not even agree with the findings of the newspaper and clarified that the so-called delay in submitting adverse event was allowed by FDA as it did not impact the safety of the device and to reduce the administrative burden on FDA to review seemingly innocuous adverse events. Whatever the reason, it seems FDA just created a lot of work for itself. There is no way to know how many malicious allegations will be submitted to the FDA and how many resources will be needed to chase all reports submitted. Malicious reports can be submitted anonymously by competitors, disgruntled employees, unhappy customers, and adversaries of a given company to create nuisance and delays. It is not clear if FDA has created a special resource to screen all the reports submitted on its website; on the contrary it seems the same department that currently reviews complaints of this sort will stay in charge of this new portal as well. Based on its experience from this portal, it is very possible that other regulated products may be added to the form. This seems like a tacit acknowledgement by FDA that it is not getting enough reports of misconduct and it believes making it easier to report will get more informants to come forward. We will find out soon, if it becomes a source of valuable information or a wasteful drain on resources.