Abbott Laboratories Escapes a Long-Running Consent Decree

After more than a dozen years, Abbott Laboratories is no longer operating under a consent decree. The settlement was made in 1999 after a remarkable six-year run of manufacturing deficiencies and subsequent failures to fix various problems in its diagnostics division. The decree was terminated last month, according to an Abbott spokeswoman. The move came after the drug and device maker was able to demonstrate an ability to remain in compliance with good manufacturing practices. “Many consent decrees that FDA enters with firms allow the firms, under defined circumstances, to seek court termination of the decrees following extended periods of compliance. That is the case with this one,” an FDA spokeswoman wrote us in an e-mail (here is an FDA statement at the time the decree was announced).

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