On Tuesday, October 25, 2016, the U.S. Food and Drug Administration (FDA or the agency) announced a new online tool and accompanying guidance for reporting allegations of regulatory misconduct to the Allegations of Regulatory Misconduct Branch within the Office of Compliance at the Center for Devices and Radiological Health (CDRH). While FDA has always had processes for receiving complaints about regulated companies and their activities, this new reporting mechanism is intended to make it easier for competitors, company employees, or other members of the public to report allegations of regulatory misconduct.

Types of Allegations

Companies often submit "trade complaints" to FDA regarding perceived violations of the federal Food, Drug, and Cosmetic Act (FDCA) by their competitors. These letters most often complain of impermissible promotional practices, including off-label promotion of cleared or approved products, promotion of unapproved products, or promotion of false or misleading claims. Historically, reports of regulatory misconduct had to be submitted through letters or e-mails to the Office of Compliance. Anonymously providing detailed information about alleged misconduct required the use of a third party to send the complaint to FDA. Without the promise of anonymity, both entities and individuals have been reluctant to make these reports for fear of retaliation by competitors or employers. Once submitted to FDA, there historically has been little clarity and certainty as to the process for the agency to perform its evaluation and what action, if any, might be taken.

FDA's new online reporting tool will streamline the complaint/allegation process by providing a single reporting mechanism for both competitors and whistleblowers. Now, company employees will be able to anonymously report allegations of alleged regulatory misconduct to FDA, providing the agency new and expanded insight into problems that it otherwise might not have seen. As a part of the guidance, FDA included a request that the report include sufficient detail to allow the agency to properly assess an allegation.

FDA has indicated that submitters using the new system will receive a letter acknowledging their complaint, which will include tracking information that can be used to follow-up on the outcome of FDA's investigation of the allegations under the Freedom of Information Act (FOIA).

FDA also included a reminder in the announcement of this new online tool to highlight that it should not be used to submit reports of adverse events, product quality problems, therapeutic inequivalence/failure, and product use errors. All reports of these kinds of product failures and significant safety risks should continue to be submitted to FDA through its MedWatch reporting system.

FDA Action

Once a complaint has been received, CDRH will assess the allegations and investigate further, if warranted, to determine the potential risk to patients. After FDA makes an assessment, the agency may take action, which could include:

  • Regulatory actions such as sending a warning letter to the medical device firm, conducting an inspection of the manufacturing facility, or requesting a device recall.
  • Contacting the individual, firm, or medical device manufacturer for additional information.
  • Monitoring the allegation using additional sources of reported information (e.g. medical device reports (MDRs), new complaints, inspection reports) to determine any action needed.

Implications

This online reporting tool has streamlined the process for reporting potential regulatory misconduct and made it easier for reports to be submitted anonymously. The tool will make FDA's Office of Compliance more accessible to those wishing to report alleged misconduct, particularly to internal whistleblowers. The accessibility and anonymity that the online reporting tool provides likely will result in an increase in the number of reports of misconduct submitted to FDA each year. Having said that, even with a significant increase in reports to FDA, the agency will still need to determine, based on the information provided, whether the alleged misconduct warrants further evaluation or investigation before there is an appreciable increase in enforcement activity.

We have seen a noticeable increase in informal inquiries and directed inspections from FDA in recent months. With the launch of this online reporting tool, we expect to see these trends continue, as FDA investigates the allegations received to determine whether more formal enforcement action is needed.