As if drug and device companies did not have enough to worry about in the wake of numerous "fraud and abuse" lawsuits brought by the government, FDA is now signaling greater emphasis on criminal prosecutions for off-label promotion. Speaking at a conference, the agency's deputy chief for litigation, Eric Blumberg, observed that "it's clear we're not getting the job done with large, monetary settlements," and suggested that the government should be willing to show more resolve to criminally charge responsible corporate officials. He emphasized the possible resurgence of the agency's ability to bring misdemeanor charges (the so-called "Park Doctrine") without having to show criminal intent. This follows on the heels, earlier this year, of a GAO report advocating increasing misdemeanor prosecutions for GMP and other violations. Some factors mentioned by Mr. Blumberg, in deciding whether to bring a "strict liability" prosecution, might include whether the conduct results in actual or potential harm, whether violations are serious, whether they are widespread (part of the corporate culture) and egregious or flagrant, and whether there have been prior warnings that have gone unheeded. He emphasized that the lack of prior warning is not a lack defense to a criminal prosecution. The tenor of these comments was echoed in remarks by CDER officials Tom Abrams and Deb Autur, who said that the Division of Drug, Marketing, Advertising and Communications was referring more complaints to FDA's Office of Criminal Investigations regarding promotional issues and that other areas of focus include good manufacturing practices of contract manufacturers, adverse event reporting and the conduct and monitoring of clinical trials.
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Off-label promotion enforcement update
- Alston & Bird LLP
- Julie Klish Tibbets, Donald E. Segal, Kim McWhorter, Robert D. Stone, Joshua L. Becker and Elinor A. Hiller
- October 28 2010
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