Park Doctrine’s Use Should Hinge On Individual’s Knowledge Of Wrongdoing, Prosecutor Says
Application of the Park doctrine to hold corporate officers strictly liable should depend upon an individual’s knowledge of wrongdoing committed under the Food, Drug and Cosmetic Act, Assistant U.S. Attorney for the District of Massachusetts Sara Bloom tells a compliance conference.
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The era of big pharma off-label promotion cases may be coming to a close, but federal prosecutors are eyeing other industry practices for enforcement, including unsupported promotional claims of economic superiority and superior efficacy, and manipulation of the average sales price system.
Almost a year after signaling its intent to target more individual executives with misdemeanor prosecutions when their companies have broken the law, FDA has published its criteria for pursuing such cases.
FDA appears likely to target flagrant off-label promotion in its first cases under new procedures for using the Park Doctrine and strict liability statutes to prosecute corporate executives and others.