On Nov. 2, 2020, the Drug Enforcement Administration (DEA) published notice of a new Proposed Rule, "Suspicious Orders of Controlled Substances," to "clarify the procedures a registrant must follow for orders received under suspicious circumstances." 85 Fed. Reg. 69282, 69284 ("Proposed Rule").

DEA's purported "clarification" of those obligations, however, includes an entirely new framework that not only is inconsistent with prior DEA guidance as to registrants' suspicious order reporting obligations, but more fundamentally represents a lost opportunity to achieve meaningful change. It remains to be seen whether the extended public comment period for the Proposed Rule will be further extended, however, a more comprehensive solution, one that unites disparate stakeholders and data sets in a committed public-private partnership, is necessary to stem the ongoing opioid epidemic. 

DEA's Prior Guidance Has Created a Lack of Uniform Industry Standards that Undermines Data Utility

The Proposed Rule represents DEA's latest interpretation of registrants' suspicious order reporting obligations. By way of background, beginning in or about 2005, DEA was confronted with an alarming rise in internet pharmacies, many without storefronts, that were filling prescriptions written by physicians located hundreds of miles from their patients. The quantities of controlled substances ordered by these pharmacies were extraordinary and facially unsupportable. In addition, many of the underlying prescriptions were invalid and written in violation of state licensing requirements that required physical examinations of patients, not online consultations. Thus, because there existed no bona fide doctor/patient relationship, the orders evinced diversion into "other than legitimate medical, scientific, and industrial channels." 21 U.S.C. §823(b)(1) (2020).