FDA Announcement Re. ReGen's Menaflex Device

Statement

Senator Chuck Grassley issued the comment below about the announcement made today by the Food and Drug Administration about the agency's concerns with its own review of the ReGen Menaflex device. (Information about the report is posted with this statement at http://finance.senate.gov and http://grassley.senate.gov.) Senator Grassley has been asking questions about the FDA's review of this product. He wrote to FDA and ReGen in March 2006, regarding allegations that ReGen influenced FDA's actions on the device.

"The report issued today is more good news about the FDA recognizing shortcomings in its review process for the majority of medical devices. The specific findings about the review of the Menaflex device track what I've found in my own review. The agency failed to follow procedures, excluded the review team from speaking before an advisory panel, and was too quick to accommodate demands made by the device manufacturer. More broadly, the report admits that the agency needs to take a closer look at the 501(k) review process to make sure it adequately protects the American people. The kind of reflection and the commitment to action made in this report is key to the FDA building public confidence in its commitment to public safety through scientifically rigorous and independent review."

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