Senators Criticize Loopholes, Delays In FDA's Adverse Event Reporting Protocol

U.S. Senators Amy Klobuchar (D-Minn.) and Al Franken (D-Minn.) have called for more transparency and reform in FDA’s protocols for reporting adverse events. An investigative report by the Star Tribune revealed that FDA accepted “retrospective summary reports” that cover hundreds of thousands of incidents, years after they occurred. FDA argued that excessive paperwork would “clog” the reporting system and be of little use to the public.

Under current FDA regulations, medical device manufacturers and importers are required to submit individual adverse event reports within 30 days of learning about deaths, serious injuries, and malfunctions associated with medical devices. In April, the Star Tribune reported that Medtronic had summarized over a thousand patient injury reports involving its controversial Infuse bone graft, and submitted them to the FDA years after the 30-day deadline had passed. The report prompted a letter from Franken to FDA.

Though FDA responded to Franken’s questions, Franken told the Star Tribune that information regarding the reporting process highlighted the need for a “more robust, proactive medical device surveillance system” and that he remained “concerned that the FDA did not disclose patient injury data in either a timely or transparent fashion.”

FDA gets so many reports beyond the 30-day deadline that the agency has created a “retrospective summary reporting program,” though the program is not documented or officially authorized by law. The agency does allow for “Alternative Summary Reporting” for common malfunctions that are predictable; cases with retrospective reporting are different and involve a review of the company’s complaint file.

A recent investigative report by Star Tribune revealed that over 300,000 adverse events — involving products from companies such as Baxter, ConvaTec, and Johnson & Johnson — had been similarly summarized and submitted to the FDA an average of three years after the first event occurred. The report’s information was obtained through the Freedom of Information Act and took more than 13 months to collect.

A spokesperson from FDA told the Star Tribune, in an e-mail, that summaries typically involved issues “well-understood” by the medical community, and that demanding additional documentation would waste the agency’s resources. Manufacturers named in the report argued that products named in the report did not cause any injuries, or that the events summarized did not contain any “new safety information.”

The Advanced Medical Technology Association (AdvaMed), an industry advocacy group, released a statement in support of summarized reports, saying they do not compromise the industry’s commitment to patient safety.  “Retrospective analysis and potential reporting of events is appropriate and allowed by FDA for a variety of reasons including implementation of the company’s quality management system,” said AdvaMed.

In a recent statement, Franken stated that FDA should restrict its acceptance of retrospective reports until reforms can be made. “Patients and physicians need to have access to all relevant safety information to make the best decisions about the best course of treatment,” said Franken.

U.S. Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-N.Y.) introduced the Medical Guardian’s Act of 2016 in June, which would require hospitals and doctors to report adverse events associated with medical devices. Sponsors of the bill argue that people in the “clinical chain of care” are in the best position to report important patient safety information.