WASHINGTON – U.S. Senator Claire McCaskill, the top-ranking Democrat on the Homeland Security and Governmental Affairs Committee, will today introduce legislation repealing the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 after media reports indicated that it had dramatically restricted the ability of the Drug Enforcement Administration (DEA) to crack down on opioid distributors suspected of wrongdoing.
“Media reports indicate that this law has significantly affected the government’s ability to crack down on opioid distributors that are failing to meet their obligations and endangering our communities,” McCaskill said. “I’ll be introducing legislation that repeals this law and continue my work investigating the role pharmaceutical distributors played in fueling this public health crisis.”
The 2016 bill purported to “improve enforcement efforts related to prescription drug diversion and abuse” by altering DEA procedures for revoking or suspending registrations for opioid distributors under the Controlled Substances Act. However, the effect of these changes, according to reports, has been to significantly curtail the ability of DEA to bring enforcement actions against drug distributors.
Earlier this year McCaskill launched an investigation into opioid manufactures—the most comprehensive Congressional investigation into the crisis to date—in when she requested information related to sales and marketing materials, internal addiction studies, details on compliance with government settlements and donations to third party advocacy groups from major opioid manufacturers. She recently expanded her investigation, requesting documents and information from opioid manufacturers Mallinckrodt, Endo, Teva, and Allergan, while a request to McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc., focused on their distribution of opioid products. In September, McCaskill announced the first round of findings, detailing systemic manipulation of prior authorization process by Insys Therapeutics.
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