Report finds delays, loopholes in FDA’s adverse event reporting

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, according to agency records obtained by the Minneapolis Star Tribune under the Freedom of Information Act.

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.

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.

“The FDA declined interview requests. Via e-mail, spokespeople said the 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, the FDA said, while doing little to protect the public,” the Star Tribune reported.

Baxter told the paper that the Colleague pump malfunctions didn’t involve injuries or have any patient impact. Medtronic said the FDA takes retrospective reports only if a company can show that they don’t contain new safety information; Johnson & Johnson initially said that retrospective summary reporting did not exist, but later acknowledged the program after the newspaper pointed out its reports. A company spokeswoman told the Star Tribune that the potential malfunctions “were for a variety of different issues” that occurred from “late 2005 to mid-2006” but were not reported to the FDA until after the deadline.

Critics said the FDA’s delayed reporting program leaves doctors and patients in the dark and poses safety concerns.

“It should not happen. The fact that [overdue adverse event reports] can be reported in summary, without details, is inappropriate and, at least in my understanding of the basic congressional intent of reporting, outside the boundaries,” according to Dr. David Challoner, leader of a 2011 Institute of Medicine study of adverse-event reporting problems, who told the newspaper that he’d never heard of retrospective summary reporting.

“Everybody who’s in a position to identify or question an adverse or unexpected clinical event is motivated not to report it,” he said, “everyone except the patient who has a question about what the hell is going wrong.”

Former Sen. David Durenberger (R-Minn.), who co-sponsored the 1990 legislation governing the FDA’s post-market surveillance monitoring, told the paper he doesn’t remember including a provision for retrospective summaries.

“I find it hard to believe that the law provides for reporting [injuries and malfunctions] and leaves that kind of a loophole,” Durenberger said. “It defies what I intended. … If there’s no penalty, there’s no law.”

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