September 13, 2019
ARLINGTON, Va. — The Healthcare Distribution Alliance (HDA) released the following statement regarding media reporting on the Ensuring Patient Access and Effective Drug Enforcement Act of 2016.
“The fundamental premise of The Washington Post’s reporting — 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. This is directly rebutted by the sworn Congressional testimony of a DEA official who stated there had never been an instance where the agency sought to use its authority to issue an immediate suspension order (ISO) against distributors and was in any way impeded in doing so as a result of the law. Further, this bill was not passed until 2016 – well after the peak of the crisis – and any suggestion that it could have affected actions prior to its passage defies common sense.
“Distributors continuously sought guidance, as well as greater communication and coordination from the DEA, but prior to 2016, these efforts were not reciprocated. HDA supported passage of EPAEDEA (S. 483) as did numerous other organizations, and ultimately, Congress and President Obama. The intent of the law was not to decrease the DEA’s enforcement against distributors; its goal was to enhance communication between all parties in order to counter the constantly evolving methods of drug diversion. HDA believed that the legislation would help provide greater clarity to one element of DEA’s enforcement standards and encourage communication and coordination that was much-needed between the DEA and the industry.
“The bill was subject to an open legislative process that involved regular, ongoing communication and consultation between congressional staff and DEA. Further, the measure passed both chambers without dissent and was signed into law by President Obama.
“We continue to advocate for policies that enhance communication between the DEA and distributors. HDA has also been proud to support legislation that further strengthens coordination and exchange of information between the industry and the DEA, such as the SUPPORT Act.
“Distributors take seriously our obligation to be part of the solution to the opioid crisis and believe that recent legislative actions as well as regulatory steps by the DEA, including their substantial reduction of opioid production quotas, have been positive.”
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.