The Minneapolis Star Tribune has published this investigative report on the FDA's adverse-event reporting system for medical devices. The Star Tribune used the Freedom of Information Act to get information from the FDA about patient injuries associated with medical devices. By law, this information should have been public in the first place.
The report is quite in-depth and well worth a read. Here are some excerpts:
Makers of medical devices, from heart valves to drug pumps, are required to tell the U.S. Food and Drug Administration whenever they learn that a product may have injured someone. Those reports are usually available to patients and their doctors. But a Star Tribune analysis of recently obtained data shows that the FDA has accepted late reports that cover hundreds of thousands of incidents, sometimes years after the fact, and has created a program that lets device makers keep the details out of view. * * * The FDA gets so many reports beyond the usual 30-day deadline that it has created a “retrospective summary reporting program” for them. No written description of the program is available on the FDA’s website, no law explicitly authorizes it and there is virtually no public paper trail of its existence. * * * Critics see two problems. First, the secret summaries leave doctors, patients and researchers without a complete record of adverse events, unless they go through a Freedom of Information process that can take more than a year. * * * Second, giving companies the ability to privately summarize large numbers of events, well after the legal deadline, could give them a way to hide safety issues.
