FDA defends response to late Medtronic Infuse data

The FDA reportedly defended its response to the 5-year delay by Medtronic (NYSE:MDT) in reporting results from an internal study of its controversial Infuse bone growth protein, saying it took no action for the late filing because the data was consistent with earlier results on Infuse.

A 2-year internal review of some 3,647 patients implanted with Infuse turned up 1,000 adverse events that should have been reported to the FDA within 30 days. Fridley, Minn.-based Medtronic shut down the review in 2008 but misfiled the data, which it reported to the FDA in 2013 after its rediscovery.

In a June 6 letter to Sen. Al Franken (D-Minn.) earlier this month, responding to his questions about the incident, the FDA’s acting associate commissioner for legislation Dayle Cristinzio explained that the agency’s call that “no enforcement actions were warranted”was made because the Medtronic study did not reveal new information, according to the Minneapolis Star Tribune.

“The types of events in these reports were similar to events seen in other reports from 2006-2013,” Cristinzio wrote.

Franken said the case shows why the federal safety watchdog needs “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 newspaper.

 

 

 

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