The Food and Drug Administration (FDA) recently introduced a new webpage for reporting allegations of regulatory violations by medical device manufacturers or marketers. The new webpage, launched on October 21, 2016, enables any person—including current or former employees, competitors, or even plaintiffs’ attorneys—to submit a report to FDA regarding a broad variety of potential violations. Illustrating the types of allegations it expects to receive, FDA identifies:
- non-FDA-approved promotion or advertising;
- failing to submit required safety reports;
- failing to comply with design or manufacturing responsibilities;
- marketing a device without proper FDA clearance;
- importing a device without satisfying the applicable legal requirements;
- forging or falsifying an export certificate;
- failing to register and list a device; and
- knowingly deceiving FDA.
FDA encourages reporters “to include supporting information and contact information in case additional information is needed for FDA to understand the allegation and act on the report.” The agency also permits anonymous reporting and guarantees that it will maintain reporters’ anonymity unless legally required to do otherwise.
According to the new webpage, all reported allegations will be reviewed by the Center for Devices and Radiological Health (CDRH). CDRH is then charged with prioritizing its review based on the level of potential risks to patients. Following an assessment of the allegation, CDRH has the option of issuing a warning letter, conducting an inspection, or even requesting a recall. CDRH may also request additional information from or simply monitor the medical device manufacturer.
FDA implemented a similar reporting mechanism in 2010, the “Bad Ad Program,” which only addresses reports of potentially untruthful or misleading prescription drug advertising and promotion, rather than the broad array of violations addressed by the new website. Also, although anyone may submit a complaint to FDA, the Bad Ad Program “is focused primarily on health care professionals” and is “designed to educate health care professionals about the role they can play in helping FDA ensure that prescription drug advertising and promotion is truthful and not misleading.” Despite its comparatively limited scope, reports submitted through the Bad Ad Program led to the issuance of a number of enforcement letters. The new website is broader in scope and may have a similar, if not greater, impact. At any rate, whether or not this new website generates additional FDA actions against medical device manufacturers, records of inquiries and investigations completed by CDRH will potentially be available to plaintiffs’ attorneys through requests under the Freedom of Information Act.