Sasha Ivanov
84 Geo. Wash. L. Rev. 776
To combat violations of the Federal Food, Drug, and Cosmetic Act, the government has recently chosen to target individual corporate officers in the pharmaceutical and medical device industries instead of just sanctioning the companies themselves. Prosecution of these officers has proceeded under the responsible corporate officer doctrine, a doctrine created by the U.S. Supreme Court as a way to impose criminal liability for public welfare offenses under a strict liability standard. Recently, the Office of Inspector General of the Department of Health and Human Services has used its statutory authority under the Social Security Act to exclude corporate officers convicted under this doctrine from participation in federal health care programs. These exclusions have devastating consequences for officers’ careers.
Because the responsible corporate officer doctrine was originally formed in the context of public welfare offenses, which are associated with minor penalties, the exclusions have gone beyond what the Court could have foreseen when it formed the doctrine. The Social Security Act should be amended to limit the exclusionary authority to only those officers who have been convicted of fraud, not those officers who are convicted solely using the burden-lowering responsible corporate officer doctrine.
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