Controlled Substance Monitoring and Effective Controls Against Diversion: Investigations and Settlements
Abuse of prescription drugs has increasingly become a top priority for the US Drug Enforcement Agency (DEA) and the US Department of Justice. Retail pharmacies and health care distributors that are in the business of distributing legal controlled substances (e.g., prescription painkillers) are increasingly facing regulatory scrutiny, and are required to proactively identify and report suspicious orders to the DEA. Analysis Group has assisted counsel for several such companies in high-profile disputes with the DEA and US Attorneys' Offices (USAOs) around the country. The disputes have hinged on how to define “statistically unusual” dispensing or distribution, absent clear regulatory guidance. To address allegations of ineffective controls against drug diversion and suspicious order reporting violations, Analysis Group consultants worked with counsel for national pharmacy chains and distributors to assess dispensing and distribution data and to explain the statistical context. The Analysis Group team has effectively rebutted statistical models created by the DEA and USAO statisticians and built alternative models that consider a variety of alternative scenarios and potential penalty amounts. Analysis Group Managing Principals Paul Greenberg and Crystal Pike, and Vice Presidents Pavel Darling and Kenneth Weinstein, have provided testimony in administrative law proceedings and made presentations to the DEA and USAOs in these matters.