Klobuchar, Franken critical of FDA's reporting program for medical devices

WASHINGTON – Minnesota's U.S. senators on Monday criticized a program that lets medical device companies report some patient injuries and product malfunctions years after learning of the incidents.

The Star Tribune on Monday revealed the existence of the U.S. Food and Drug Administration's "retrospective summary reporting" program, under which companies have disclosed more than 300,000 adverse events, as the FDA calls them. Normally, companies must file individual reports within 30 days of learning about an adverse event.

Sen. Amy Klobuchar said the retrospective summary reporting program "stands in the way" of keeping the public informed. Typically the FDA makes only a few sentences of summary material available to the public, while information on individual adverse events stays confidential.

"All patients deserve to know the risks and side effects of a medical procedure and a medical device," Klobuchar told the Star Tribune. "The current reporting system should be strengthened to ensure patients have critical information about products as quickly and efficiently as possible."

Sen. Al Franken said the FDA's system for monitoring devices is more generally flawed, beyond the retrospective summary reports, and called for change.

"Patients and physicians need to have access to all relevant safety information to make the best decisions about the right course of treatment," Franken said. "But right now, that doesn't always happen. That's why I've been pushing to revamp our medical device reporting system."

The FDA said it only grants retrospective summaries for problems that are well-known. The agency said requiring additional paperwork for overdue adverse event reports would not advance public health and would be onerous for device makers and the government.

AdvaMed, a national medical device group, defended summary reporting.

"The medical technology industry is committed to patient safety and compliance with all FDA regulations including postmarket reporting," the group said in a statement. "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."

The Star Tribune first reported in April that Medtronic was late to report a company-run study of its Infuse Bone Graft, which has been the subject of multiple government investigations. The study revealed more than 1,000 potentially product-related injuries and malfunctions roughly six years after individual reports were due.

The company filed a 76-page table on the study, but only a three-sentence summary became public.

At the time, Franken, a member of the Senate's Health, Education, Labor and Pensions Committee, and Klobuchar each sought explanations from the FDA and Medtronic. The company said it misplaced the study, and the FDA defended the use of a summary because it had heard of similar injuries and malfunctions from other sources.

Going forward, Klobuchar said she supports "a national evaluation system" that "would improve reporting requirements."

Franken said that until reforms can be made, the FDA should minimize the use of retrospective summary reports in the interest of transparency. "Patients," he said, "deserve nothing less."

Jim Spencer • 202-662-7432