The US Food and Drug Administration yesterday announced that a consent decree of permanent injunction has been filed against McNeil-PPC, the consumer products division of Johnson and Johnson, and two of its senior executives, for “failing to comply with current good manufacturing practice requirements as required by federal law. The action prevents McNeil, a subsidiary of Johnson & Johnson, from manufacturing and distributing drugs from its Fort Washington, Pa., facility until the FDA determines that its operations are compliant with the law.”
McNeil Consumer Healthcare Division’s Vice President of Quality Veronica Cruz and the company’s Vice President of Operations for OTC Products Hakan Erdemir were named defendants in the consent decree, filed with the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia on March 10, 2011. The highest ranking company executives in charge of the facilities named in a consent decree are always included (by law) on the civil action.
The decree also requires McNeil to adhere to a strict timetable to bring its facilities in Las Piedras, Puerto Rico, and Lancaster, Pa., into compliance.
Consent decrees are civil actions—not criminal ones— and are meant to be remedial rather than punitive. In other words, there are no fines levied and the agency expects the companies under consent decree to bring their manufacturing facilities back in to compliance with Current Good Manufacturing Practices (CGMP). However, if the company fails or refuses to comply with the FDA, criminal charges can be filed against the companies and the two executives mentioned in the consent decree. The agency had little choice but to seek a consent decree of permanent injunction against McNeil because of manufacturing problems and recalls of several of its signature brands including Tylenol, Motrin, Zyrtec, and Benedryl. Criminal charges may be forthcoming because of possible cover ups of the recall that involved hiring outside contractors to purchase tainted produced in bulk to surreptitiously remove them from store shelves.
FDA had little choice but to seek a consent decree because of the seriousness and continuous nature of the problems at its Fort Washington production facility and the fact that J&J senior executives were either unaware or unconcerned with the problems at its subsidiaries. While working under a consent decree may be embarrassing for J&J, the damage caused by the recalls of some of its most visible consumer and OTC brands may be irreparable.
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