Off-Label Prosecution May Be Where FDA "Parks" Aggressive Enforcement Tools First
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.
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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.
As penalties increase under responsible corporate officer doctrine, attorney Allison Burroughs, a partner at Nutter McClennen & Fish, says to expect increased scrutiny.
Making A Federal Case Of Marketing Abuses: FDA Trains OCI Staff On Developing Cases Worth Prosecuting
FDA is training investigators in its Office of Criminal Investigations on how to pursue cases against individuals for off-label drug promotion so that they are able to convince U.S. Attorneys' Offices to prosecute them.