Health Care & Hospital Law
Feb. 16, 2011
Biotech Still in the Dark on Prosecutions
The FDA released criteria for the agency's use of the Park Doctrine to prosecute pharmaceutical and medical device executives, but the guidance provided little clarity for lawyers and their clients.
Daily Journal Staff Writer
Biotechnology executives looking for clear terms under which they could face career-ending misdemeanor charges for misdeeds at their companies are still in the dark after the U.S. Food and Drug Administration released guidance on the Park Doctrine this month.
Based on a 1975 U.S. Supreme Court case, the Park Doctrine says the government can charge a responsible corporate officer with a misdemeanor vi...
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