In Ruan v. United States, the U.S. Supreme Court on June 27, 2022, dealt a blow to the U.S. Department of Justice by vacating convictions of two physicians convicted of violating 21 U.S.C. ยง841(a) of the Controlled Substances...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) on July 8, 2021, issued Advisory Opinion No. 21-08, a favorable opinion authorizing a manufacturer of gene therapy to provide...more
A recent U.S. Department of Justice (DOJ) settlement should serve as a reminder that pharmaceutical manufacturers are not the only entity in the drug supply chain that are susceptible to enforcement actions with respect to...more