In one of the final cases of a tumultuous term at the Supreme Court, the Justices ruled against DOJ in a decision that could have wide ranging effects not just for physicians and other prescribers, but for drug control laws more generally. In Xiulu Ruan v. U.S., No. 20-1410 (Jun. 27, 2022), the Court considered the convictions of two physicians for violating the Controlled Substances Act, 21 U.S.C. § 841 because, DOJ contended, and the respective juries found, that their prescriptions were “not authorized.” (The relevant statute makes it a federal crime to “[e]xcept as authorized[,]….knowingly or intentionally…dispense…a controlled substance.” Id.). One physician was sentenced to 20 years imprisonment; a second to 25 years. Each, at trial, had contended that their prescriptions were authorized, that they had the requisite credentials to write prescriptions, including DEA and state board registrations, and that they were properly licensed. DOJ, meanwhile, had argued that the physicians were operating “pill mills” and, accordingly, their prescriptions were not “authorized.”
Joseph Jay is a white collar defense and government investigations partner in the firm's Washington, D.C. office.
U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning Letters”). In just the last week, the USAO for the Eastern District of Wisconsin sent warning letters to over 180 prescribers identified by Drug Enforcement Administration (“DEA”) data as prescribing opioids at relatively high levels. The Food and Drug Administration and the Federal Trade Commission have also been issuing their own warning letters to opioid marketers and distributors over the past several months, evidencing a concerted effort to combat the opioid epidemic on a number of fronts through various federal enforcement and regulatory efforts.
Continue Reading Compliance Risk Alert: Opioid Warning Letters issued by the U.S. Department of Justice Target Prescribers