New FDA "Whistle-Blower" Website Accepts Allegations Against Device Makers
FDA has launched a new website that will allow the public to file complaints of regulatory misconduct against device manufacturers. The Center for Devices and Radiological Health (CDRH) will review the allegations, determine potential risk to patients, and take action as warranted.
A recent investigative report published by Star Tribune alleged that the device industry was taking advantage of loopholes in the FDA’s adverse event reporting protocol to obscure the true number of device-related complications in “retrospective summary reports” released years after the events took place. Star Tribune obtained data on over 300,000 adverse events — involving products from Medtronic, ConvaTec, Baxter, and J&J — reported using these summaries.
The investigation prompted a letter from U.S. Sen. Al Franken (D-Minn.) to the FDA, and though the agency has answered all of the senator’s questions, Franken told Star Tribune that the matter highlighted the need for “a more robust, proactive medical device surveillance system.”
Using the FDA’s Allegations of Regulatory Misconduct website, any person who suspects wrongdoing by device manufacturers or individuals marketing medical devices can fill out a simplified form to be reviewed by the CDRH. The agency provided several examples of potential allegations, including advertising a device for an unapproved indication, failure to submit reports of adverse events, marketing a device without FDA clearance, illegal device imports, or any other case where a manufacturer knowingly deceives the FDA.
“Reporting these allegations can help make the FDA aware of regulatory concerns it may not learn of otherwise,” said FDA in a statement. “This information can help the FDA identify the potential risks to patients and determine whether further investigation is warranted, as well as any steps needed to address or correct a potential violation.”
FDA encouraged those submitting reports to include supporting evidence of their claims, and to leave their names and contact information, but specified that allegations still will be reviewed without this additional information. The forms can be submitted via e-mail or regular mail. The CDRH will contact individuals who provide their information, but information regarding investigation outcomes also will be available through the Freedom of Information Act. FDA will not share the identities of those filing reports unless required to do so by law.
An FDA spokesperson told Star Tribune that the new website was not launched in response to recent events, but stated that it would provide the “public with more information on allegations related to medical devices and clear instructions for reporting to the FDA.”
According to public health advocates, the success of the website will depend on the CDRH’s diligence in following up on claims made through the submitted forms, and its willingness to enforce regulatory laws that protect patient safety.
“This is a good idea, but the question is: what resources will the CDRH devote to this to ensure that the allegations of misconduct are followed up and dealt with accordingly?” asked Diana Zuckerman, president of the National Center for Health Research.