Controlled Substance Monitoring and Effective Controls Against Diversion: Investigations and Settlements

Abuse of prescription drugs has increasingly become a top priority for the U.S. Drug Enforcement Agency (DEA) and the U.S. 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 U.S. 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 staff 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 Principal Paul Greenberg, Vice President Crystal Pike, and Managers Kenneth Weinstein and Pavel Darling have provided testimony in administrative law proceedings and made presentations to the DEA and USAOs in these matters.