FDA launches public whistleblower site for ‘regulatory misconduct’

The FDA last week launched a whistleblower website designed to let whistleblowers let the federal safety watchdog know about allegations of “regulatory misconduct” on the part of medical device makers.

The online “Allegations of Regulatory Misconduct Form” allows anyone to report an allegation of regulatory misconduct to the FDA, the agency said Oct. 21.

“The FDA encourages people submitting allegations to include supporting information and contact information in case additional information is needed for the FDA to understand the allegation and act on the report; however you can choose to submit a report anonymously,” the agency said.

The launch of the site and last week’s announcement follow the discovery by the Minneapolis Star Tribune this year that the FDA allows medical device companies to file adverse event reports well after the fact and to conceal most of the details from public view.

The newspaper’s analysis showed that the FDA allowed medical device companies to file “retrospective summary reports” covering more than 300,000 adverse events, at an average of about 3 years after the 30-day filing deadline. Since 2005 the FDA has let some 2 dozen firms file late reports, the newspaper found, after waiting 13 months for the agency’s response to its FOIA request and then challenging a decision to cloak some of the totals as corporate trade secrets.

For example, Baxter (NYSE:BAX) posted 75,000 reports of problems with its since-recalled Colleague drug pump, but publicly disclosed only a single, brief summary until the newspaper’s challenge. The FDA let ConvaTec delay reporting details on 324 reports of problems with its Flexi-Seal Signal fecal incontinence device for 3 years, the paper reported, and allowed Medtronic (NYSE:MDT) to retroactively summarize some 1,000 incidents involving its Infuse bone-stimulating graft. Johnson & Johnson (NYSE:JNJ) diabetes subsidiary LifeScan reportedly revealed 186,000 potential malfunctions in a pair of glucometers in 2 summary reports filed one day in 2006.

An FDA spokeswoman told the newspaper that the regulatory misconduct reporting tool was not announced in response to its reporting. It “was developed to provide the public with more information on allegations of regulatory misconduct related to medical devices and provide clear instructions for reporting to the FDA,” she said.

The types of alleged misconduct that can be reported include failure to register and list a medical device, marketing uncleared or unapproved products, failure to follow quality system requirements or misleading or off-label promotion, according to the FDA. Whistleblowers should include the name of the device in question, its manufacturer and their contact information and any lot, serial and part numbers. Complainants should also include the unique device identifier and recall numbers, if known, the agency said, along with a detailed description of the alleged violation and any supporting documents.

The FDA said its Center for Devices & Radiological Health reviews whistleblower allegations “based on the level of potential risks, within the context of an overall benefit-risk profile, to patients” using different processes based on the type of allegation. Complainants must file a Freedom of Information Act request to learn the outcome of their allegation.

“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?” Diana Zuckerman, president of the National Center for Health Research, told the Star Tribune.

The new FDA whistleblower form “will be insufficient unless the agency appropriately investigates … and takes robust enforcement actions against companies that place patients at risk,” added Dr. Michael Carome, director of Public Citizen’s health research group.

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