September 12, 2019
The fundamental premise of recent media coverage — that the passage of the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 (EPAEDEA) weakened the Drug Enforcement Administration’s (DEA) enforcement authority during the opioid crisis — is factually incorrect.
Distributors continuously sought to communicate and coordinate with DEA to better understand our reporting responsibilities under the Controlled Substances Act (CSA), but prior to 2016, these efforts were not reciprocated.
The Government Accountability Office (GAO) recognized that a lack of communication from DEA to distributors was hampering efforts to effectively combat prescription drug diversion.
The DEA itself acknowledged past shortcomings in effectively communicating with registrants.
The legislation simply clarified the definition of “imminent danger” required to issue an immediate suspension order (ISO) where none had previously existed — a definition agreed to by the DEA and Department of Justice (DOJ) before enactment of the law.
Senior officials from the DEA’s Office of Diversion Control have publicly stated that the law has not diminished DEA’s enforcement efforts.
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.