Senate colleagues in order to discuss the need to strengthen Drug Enforcement Administration (DEA) enforcement against opioid distributors and her bill to repeal the Ensuring Patient Access and Effective Drug Enforcement Act of 2016. Public reports have indicated that the law, along with a revolving door between the DEA and drug distribution industry, had dramatically restrained the agency’s enforcement efforts.
“This legislation was clearly not helpful in terms of removing a valuable tool that was a deterrent…a deterrent to some of the largest companies in America that there were serious and significant consequences if they didn’t do it by the book,” McCaskill said. “When you remove that deterrent, then things get even sloppier, and when things get sloppy in the area of opioids, people die. Innocent people die….So we will do our best to undo the damage that has been done.”
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.
Participants at today’s roundtable included Joseph Rannazzisi, former head of the DEA Office of Diversion Control; Frank Younker, former DEA Diversion Group Supervisor, Cincinnati Resident Office; and Jonathan P. Novak, former DEA enforcement attorney. The DEA denied permission for its Chief Administrative Law Judge John J. Mulrooney II to participate in the roundtable.
Earlier this year McCaskill launched an investigation into opioid manufactures—the most comprehensive Congressional investigation into the crisis to date—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 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 the prior authorization process by Insys Therapeutics.