Consent Decree Tempers J&J Consumer Outlook Even As Remediation Ends
This article was originally published in The Pink Sheet Daily
CFO Dominic Caruso says the firm is more consistent with distributing previously recalled OTCs. U.S. OTC sales jumped 10.7% and “steady progress” is anticipated when the firm completes its remediation responsibilities under a consent decree with FDA.
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J&J/McNeil enter a guilty plea in federal court to a misdemeanor charge of distributing adulterated drugs and agree to pay a criminal fine of $20 million and forfeit $5 million. McNeil has submitted to FDA experts’ certifications of remediation processes being complete at its three facilities subject to a consent decree.
McNeil scaled up its manufacturing “volume and complexity substantially” following J&J’s acquisition of Pfizer’s consumer business in 2006, says McNeil Consumer VP Shane Freedman. “Just a few years later, we had the recalls” that led eventually to a consent decree with FDA,” he says.
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