Pharma Execs Can't Duck Prosecutors With Off-Label Ruling

Law360, New York (February 25, 2013, 5:21 PM EST) -- Pharmaceutical company executives hopeful that the U.S. Food and Drug Administration might refrain from prosecuting individuals for their company's off-label marketing misdeeds, after a landmark Second Circuit decision backed a sales representative's right to promote a drug's off-label uses, are in for a rude awakening, experts say.

Over the past few years, the FDA has begun using the responsible corporate officer doctrine, also known as the Park Doctrine, to bring misdemeanor charges against pharma executives. Under the Park Doctrine, responsible corporate officers of a company, usually...
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