Does the record-setting Abbott consent decree signal a more stringent FDA enforcement policy?
James G. Dickinson Also: • Targeting device CEOs gets their attention and a fix • FDA approvals chief departs • Why don’t device firms use innovative reviews • FDA abandons Internet promotion guidance The warm and fuzzy climate of FDA’s regulatory relationship with medical device manufacturers may be turning a bit chilly. Initiated by the Clinton Administration’s “reinventing government” program and the agency’s own complementary “reengineering” initiative at CDRH, and fostered by the FDA Modernization Act (FDAMA), the atmosphere of friendly cooperation is looking bleaker in the wake of November’s record-setting consent decree with Abbott Laboratories. The $100 million decree exceeds the previous record of $61 million also against a device company dating from the 1993 C.R. Bard settlement. Abbott announced it was taking a $168 million charge against its assets to allow for lost sales and administrative costs it will incur in implementing the manufacturing and personnel changes required
