Investigative Report: FDA Rules Allow Medical Device Manufacturers to Hide Adverse Events

Investigative Report: FDA Rules Allow Medical Device Manufacturers to Hide Adverse EventsAn investigative report by the Minneapolis Star Tribune has found that the U.S. Food and Drug Administration (FDA) has created a program that lets medical device makers hide adverse events for up to several years by allowing them to submit summarized confidential reports.

The Star Tribune analyzed FDA data received under the Freedom of Information Act and said that the FDA has accepted late reports covering hundreds of thousands of incidents under its “retrospective summary reporting program.” That program allows medical device manufacturers to provide a summary of adverse incidents rather than individual incident reports, sometimes covering years of incidents.

For example, the Star Tribune said that the FDA allowed Baxter International to summarize 75,000 previously unreported malfunctions of its Colleague drug pump into a confidential report, releasing only a short summary to the public. The company later recalled that product.

According to the report, the FDA has allowed more than 20 medical device manufacturers to submit retrospective summaries involving over 130,000 overdue adverse events since 2005. However, the Star Tribune noted that the retrospective summary program is not found anywhere on the FDA’s website and there is no law that authorizes it.

The report found that late reports have also been submitted on several medical devices that are currently facing extensive litigation, including vaginal mesh.

The FDA told the Star Tribune that the retrospective summaries “involve issues that are already well-understood by the medical community. Demanding additional documentation would waste resources and clog the public reporting system for adverse events, while doing little to protect the public.”

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