By Jim Spencer and Joe Carlson Star Tribune
The U.S. Food and Drug Administration is defending a decision to accept more than 1,000 patient injury reports from Medtronic in summary form, years after they were supposed to be submitted.
The FDA responded earlier this month to questions from U.S. Sen. Al Franken of Minnesota by saying it took no action against Medtronic for the late reporting of a study of its Infuse bone graft because the information was consistent with data the agency already had.
Franken had inquired after the Star Tribune recently reported about the study, which Medtronic shut down in 2008 without reporting injuries it had found. The FDA didn’t get the study data until 2013, though federal law requires companies to report injuries within 30 days of discovering them.
The revelation of the lost study followed years of questions about how forthcoming Medtronic has been about Infuse, a product that has brought in billions of dollars in sales while attracting multiple government investigations and thousands of patient injury claims.
After receiving the FDA’s response to his questions, Franken says the handling of Medtronic’s Infuse study signals a broader need to change how the agency safeguards the public’s health. He called for “a more robust, proactive medical device surveillance system to avoid potentially dangerous reporting errors.”
“While the agency’s response provided some valuable information about the process that FDA and Medtronic undertook once the company came forward with the new adverse event information, I remain concerned that the FDA did not disclose patient injury data in either a timely or a transparent fashion,” Franken told the Star Tribune.
In the FDA’s response to Franken, Acting Associate Commissioner for Legislation Dayle Cristinzio said the agency determined that “no enforcement actions were warranted” because the Medtronic study did not reveal new information.
