Sen. Al Franken recently offered direct criticism and inquiry to both Minneapolis-based Medtronic and the Food and Drug Administration in regards to their respective handlings of a study on Medtronic's Infuse Bone Graft product, according to the Star Tribune.
The Democrat from Minnesota wrote letters to both recently confirmed FDA Commissioner Robert Califf, MD, and Medtronic CEO Omar Ishrak. The letters — delivered Tuesday — raise concerns to both parties regarding a retrospective study of 3,647 Infuse patients from 2006 to 2008. The study was reportedly halted without reporting more than 1,000 adverse events to the federal government within 30 days, which is the legal obligation of the company.
Medtronic has acknowledged the information should have been reported sooner, but stated that employees initially misfiled it. It took five years for the company to report the information to the FDA.
"This lack of information potentially skewed the risk profile of the device, which may have affected the treatment of thousands of additional patients," Mr. Franken wrote to Mr. Ishrak and Dr. Califf.
Mr. Franken — a member of the Senate Health, Education, Labor and Pensions Committee —went on to question the regulatory vigilance of the FDA. "Despite the fact that the [FDA] had previously issued two warning letters to Medtronic regarding the late submission of other adverse event data...did the agency consider taking additional steps to penalize the company for noncompliance? If not, why?" wrote Mr. Franken.
In regards to the senator's letter and the comprehensive Star Tribune special report about the Infuse study that spurred Mr. Franken's discontent, a spokesman for Medtronic told the Tribune, "The Star Tribune article makes insinuations that are false and fails to include important information regarding the [retrospective chart review] and Medtronic's actions...we look forward to further discussing these issues with Sen. Franken and his staff in our response."
The FDA reportedly told the Tribune they'd be issuing a direct response to Sen. Franken.
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