Among the examples of things that might be reported through the webpage are charges that manufacturers or marketers improperly promoted non-FDA-approved uses of products or that companies failed to tell the FDA about “device-related safety concerns” as federal regulations require.
In April, the Star Tribune reported that Medtronic was slow to report more than 1,000 injuries and malfunctions related to a company-run study of its Infuse Bone Graft. The adverse events should have been reported individually to the FDA in 2008. Instead, they were summarized in a single medical device report in 2014.
Last week, the Star Tribune reported that the FDA’s retrospective summary reporting program allowed at least two dozen device makers, including Medtronic, to keep from public view overdue details of injuries and malfunctions possibly related to their products.
An FDA spokeswoman said the webpage was not a response to recent news articles. 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.”
The agency, which is charged with protecting patient safety and public health, said that “reporting allegations can help make the FDA aware of regulatory concerns it may not learn of otherwise.”
“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.”
Besides prohibited off-label promotion and failure to report potential product-related problems, the FDA said the webpage will be a place to expose devices or manufacturing processes that do not meet government standards, to reveal efforts to hide information from the FDA, or to point out regulatory issues with imported medical devices.
Charges will be assigned tracking numbers, assessed by FDA’s Center for Devices and Radiological Health, and given priority based on the potential risk to patients, the FDA spokeswoman told the Star Tribune. Penalties could include inspections of device facilities, warning letters or recalls.
Sen. Amy Klobuchar of Minnesota applauded the new webpage’s “potential to strengthen oversight and safety of medical devices.”
“All patients deserve to know the risks and side effects of a medical procedure and a medical device in order to make informed decisions about their care,” she said.
Patient safety advocates and health researchers welcomed the effort to make it easier and simpler to let the FDA know about possible misconduct. Still, they said, what matters most is the agency’s willingness to follow through on what it is told.
“This is a good idea, but the question is: what resources will the Center [for Devices and Radiological Health] 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.
Dr. Michael Carome, director of Public Citizen’s health research group, said the new webpage “will be insufficient unless the agency appropriately investigates … and takes robust enforcement actions against companies that place patients at risk.”
©2016 the Star Tribune (Minneapolis) Distributed by Tribune Content Agency, LLC.
