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| If you don't want a visit from the Department of Justice, pay attention to the new enforcement policies the DOJ is following. |
by James R. Phelps
Hyman Phelps & McNamara, P.C
Reprinted with permission. First appeared October 22, 2015 in FDA Law Blog.
Last Thursday, at the 16th Pharmaceutical Compliance Congress and Best Practices Forum, Principal Deputy Assistant Attorney General for the Justice Department’s Civil Division, Benjamin Mizer, reviewed enforcement policies that the Department of Justice will follow. Appropriate to the forum, he focused on the industries regulated by FDA. The emphasis he gave to the requirements for settling civil and criminal cases brought against organizations gives sharp focus to the problem of doing business when governed by a law that operates with a malum prohibitum standard of liability, a law that permits findings of criminal guilt without proof of intent or guilty knowledge.
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