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The U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) recently announced its plan to update the format of and public notice protocol for its voluntary, nonbinding compliance program guidances (CPGs) based on feedback it received as part of HHS-OIG’s Modernization Initiative and other input.
Interesting post by Paul E. Kalb and Coleen Klasmeier on the intersection of the Caremark and "the Park doctrine, also known as the 'responsible corporate officer' doctrine, a line of federal cases holds that individuals who bear a 'responsible relation' to a violation of the Federal Food, Drug, and Cosmetic (FD&C) Act can be found criminally liable even without proof of traditional mens rea (guilty mind)."
Though the Biden administration’s first year kept enforcements light, broad shifts and specific measures taken by regulators are set to affect the health care and life sciences industry through 2022. The following lays out enforcements companies will likely experience over the next twelve months.
United States: Increased Scrutiny Has Boards Of Directors In The Hot Seat (Podcast) 09 November 2021 by Samir A. Gandhi , Holly J. Gregory and Paul Kalb Sidley Austin LLP To print this article, all you need is to be registered or login on Mondaq.com. Life is getting harder for boards of directors of public companies. Increased scrutiny of companies — particularly in heavily regulated industries — has led to greater risk of criminal and civil liability.
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