YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

The Drug Enforcement Administration (DEA) recently announced an enhancement to the Automation of Reports and Consolidated Orders System (ARCOS) to allow DEA-registered drug manufacturers and distributors to access anonymized information concerning their customers’ orders of certain controlled substances. Manufacturers and distributors of Schedule I and II and certain other Schedule III controlled substances are required to submit quarterly reports to ARCOS of controlled substance purchases and sales. With this enhancement, registrants will be able to view ARCOS data submitted by other manufacturers and distributors. Specifically, registrants will be able to see and download data on a customer’s (e.g., pharmacy’s) controlled substance purchases, in terms of both the amount of purchased controlled substances and the number of distributors from which controlled substances were procured. While this enhancement will help controlled substance manufacturers and distributors fulfill their suspicious order monitoring obligations, it also raises questions regarding the steps that distributors and manufacturers will be required to take if suspicious order patterns are detected.