Franken Wants Infuse Answers

Sen. Al Franken (D-MN) is asking FDA for answers to questions about its role in maintaining vigilance over medical devices. Franken’s questions in a 4/12 letter to FDA commissioner Robert Califf stem from a Minneapolis Star Tribune article detailing issues with Medtronic’s Infuse bone graft device that reportedly were not submitted to the agency for five years.

“This lack of information potentially skewed the risk profile of the device, which may have affected the treatment of thousands of additional patients,” Franken says. “This article also raises troubling questions about FDA’s insufficient vigilance in its industry-watching role. The article, coupled with other recent high-profile product failures demonstrates, again, that the nation’s current postmarket surveillance system is inadequate, outdated, and fails to protect sufficiently American consumers.”

The letter asks Califf to respond to these questions:

• What information did Medtronic provide to FDA about adverse events identified by a company retrospective study and when, and how did the agency advise the company to respond?
• In what ways did the current postmarket system, as well as its reporting structure, limit FDA’s ability to fully capture the Medtronic adverse event information earlier?
• Given that Medtronic received two Warning Letters about the late submission of other adverse event data, did FDA consider taking additional steps to penalize the company for noncompliance? If not, why not? What enforcement mechanisms does the agency employ to make sure that companies comply with reporting requirements and what consequences do companies face if they don’t comply?
• Why was public release of the Medtronic adverse event report data drawn out over several months and why did FDA initially deem the number of patient injuries to be a “corporate trade secret”?
• What steps has the agency taken to ensure that manufacturers have adequate systems in place to train staff and report complete adverse event information in a timely manner?
• Can FDA provide more detail on the range of injuries captured in the previously unsubmitted adverse event data? What proportion of those injuries are related to approved versus unapproved uses of Infuse? Can FDA describe the severity of these adverse events and to what extent were they related to the Infuse bone graft? Is the fact that there were 1,039 reports associated with 1,647 patients consistent with other data the agency had on the Infuse product before receiving the unsubmitted adverse event data and how does that incidence compare with other widely used Medtronic devices?
• Given the additional information provided by Medtronic, has FDA considered taking further steps to warn providers or patients about the product’s risks, especially the risks associated with off-label use?
• What aspects of the proposed National Medical Device Evaluation System (legislation that Franken has co-sponsored) could prevent something such as this case from happening again and what more can Congress do to support implementation of this type of system? How quickly could FDA set up such a system with that support?