March 24th, 2011

FDA takes aim at corporate executives to reign in pharma abuses

Modern Medicine

FDA has a new target in its continuing efforts to clean up pharmaceutical industry abuses: individual corporate officials. The most recent targets are the vice president of quality and the vice president of operations for OTC Products at McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson. The two are named as defendants in a consent decree of permanent injunction for failing to comply with current good manufacturing practice requirements at plants in New York, Pennsylvania, and Puerto Rico that resulted in massive product recalls.

The tactic of going after individuals is no surprise to industry insiders. FDA warned last November that it was resurrecting a 1970s legal doctrine to bring criminal charges against top executives. The goal, said Eric Blumberg, FDA deputy chief counsel for litigation, was to “change the corporate culture” at firms that have shrugged at billion dollar penalties.

“It is clear that fines are not working here,” Blumberg told a Food and Drug Law Institute meeting in Philadelphia. “We need to put something else on the scale to make people think twice, three times.”

Blumberg was talking about illegal drug marketing. Eli Lilly paid $1.4 billion in 2009 for crossing the line in marketing Zyprexa (olanzapine) and Pfizer paid $2.3 billion for illegal marketing of Bextra (valdecoxib).

FDA’s weapon of choice is the Park Doctrine, based on a 1975 case against Acme Markets President John Park. FDA charged Park personally with sanitation violations following multiple warning notices. The U.S. Supreme Court agreed that Park, as company president, was ultimately responsible for ensuring compliance.

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