No New Info in Late Infuse Reports: FDA
FDA says that adverse event reports submitted several years late by Medtronic for its Infuse bone graft did not provide any new information and did not warrant enforcement action. The agency statement is in a seven-page response to questions posed 4/12 by Sen. Al Franken (D-MN).
The response says that Medtronic notified the agency in 2013 that it had become aware of adverse event reports from a 2006-2008 study that had not been assessed for Medical Device Reporting reportability or reported to FDA. “Although we did not receive Medtronic’s summary reports until 2/27/14, the types of events in these reports were similar to events seen in other reports from 2006-2013 and added little to our understanding of the benefit-risk profile for the device,” the letter says. “FDA had received hundreds of other MDRs about the Infuse bone graft from the manufacturer between 2006 and 2013, which allowed FDA to evaluate the issues raised in the summary reports.”
Asked if FDA had considered enforcement action due to the lateness of the reports, the agency said it had evaluated the situation, including considering the findings from inspections of Medtronic that included review of medical device reporting practices. “Based on the results of those inspections,” it wrote, “FDA determined no enforcement actions were warranted. Further, Medtronic complied with FDA’s request to submit the reports in summary format, and those reports did not reveal new information.”
Franken’s letter noted that some of the late reports were published with the number of injuries initially redacted as confidential trade information. FDA responded that the information had been inadvertently redacted and the information in the agency adverse event database was corrected and re-posted on the FDA Web site.
The senator also referred to legislation he has co-sponsored to support a National Medical Device Evaluation System at FDA, which would allow the agency to more actively collect, analyze, and act on information about medical device performance. The agency response said that FDA has worked collaboratively with patient and consumer advocacy groups, healthcare providers, payers, and industry to lay the foundation for a national evaluation system for medical devices. In the past five years, it says, it has completed or engaged in some 50 projects and spent more than $10 million to help establish a national evaluation system.
“The principal barrier to implementing a national system is funding,” the letter declares. “Congress and industry invested in the Sentinel system for drugs and biologics, but there has not been a similar investment for medical devices. For the national evaluation system to become operational and become a valuable resource for patients, providers, payers, government, and industry, funding is needed to continue the work FDA and others are already doing. Funding will support increasing the number and types of devices that can be evaluated within the system, lowering the cost and increasing the efficiency of evidence generation to support better understanding device safety and effectiveness, supporting evidence generation to understand how devices perform in more patients and in diverse patient populations, and increasing the availability of evidence for patients and providers to make better informed decisions about treatments.”