On October 24, 2016, the FDA announced the launch of a new webpage at fda.gov titled “Reporting Allegations of Regulatory Misconduct.” The new webpage allows anyone to “file a complaint reporting an allegation of regulatory misconduct” by medical device manufacturers or individuals marketing medical devices. Although the FDA encourages people making the reports of alleged regulatory misconduct to provide contact information, the new webpage permits anonymous reporting. Thus, reports can be made without ever knowing the source or the agenda of the person making the report.
According to the announcement for the new webpage, this new reporting process “can help make the FDA aware of regulatory concerns it may not learn of otherwise.” The new webpage includes a table of examples of allegations. The table includes claims that manufacturers or individuals are promoting devices for off-label uses; failure of manufacturers to submit required medical device safety reports (MDRs); failure to meet design or manufacturing responsibilities; marketing a device with 510(k) clearance or PMA approval; and several violations concerning importation or registration of devices. Of course, the list also includes the catch-all of a manufacturer knowingly deceiving the FDA by hiding information or falsifying documents.
The new webpage makes it easy to submit a report by simply clicking on the “Allegations of Regulatory Misconduct Form” link under the question “How do I submit an allegation about a medical device manufacturer to the FDA?” which is located in the middle of the page. The form itself is also quite simple and merely asks the reporter to complete six sections along with the reporter’s name and email address if the reporter wants to provide identifying information. The six categories of information on the form are:
- Name of the company;
- Address of the company, if known;
- Telephone number of the company, if known;
- Name of the device and model (if applicable);
- Lot numbers/serial numbers/part numbers;
- Detailed description of the allegation with any available supporting documentation.
According to the FDA, it will prioritize review of allegations “based on the level of potential risks, within the context of an overall benefit-risk profile, to patients.” Based on the FDA’s investigation into the allegations, it expressly advises that it might issue warning letters, inspect the manufacturer’s facilities or request a device recall.
While patient advocates may applaud the launch of this new webpage, medical device manufacturers and their employees might justifiably be concerned about abuse of this new reporting process. Plaintiffs’ lawyers already use the citizen petition process to try to bolster claims against pharmaceutical and medical device manufacturers. A defense lawyer does not need an overactive imagination to conjure scenarios in which lawyers encourage (or even make) these reports to enhance their litigation claims, including qui tam claims, against device manufacturers. Likewise, individuals could abuse the system by falsely making claims against other individuals. One such easy to imagine scenario would be a sales representative anonymously claiming that a competitor’s sales representative is promoting a device for off-label uses. If the FDA’s investigation includes gathering information from the doctors to whom the alleged off-label promoting sales representative markets the device, then the damage to that individual’s reputation could be substantial even though the report might be unsubstantiated.
Device manufacturers and their employees should be aware of the new webpage and be prepared to respond to FDA investigations concerning reports made on the new webpage.