WASHINGTON – After announcing earlier this week that she would be leading a roundtable discussion on November 28 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, U.S. Senator Claire McCaskill today slammed the DEA’s decision to refuse permission for its Chief Administrative Law Judge John J. Mulrooney II to participate. In a forthcoming article, Judge Mulrooney sharply criticizes the law McCaskill is working to repeal.
The roundtable will be held on Tuesday, November 28 at 2:30 PM ET in Dirksen Senate Office Building Room 562. Participants will include 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. In addition to the DEA denying permission for Judge Mulrooney to participate, the DEA declined McCaskill’s request for the agency to send a representative to the roundtable. The Healthcare Distribution Alliance—a major trade association for drug distributors—also declined to participate.
“[DEA’s] decision to muzzle a critic of this law is unacceptable while the U.S. opioid epidemic rages out of control,” McCaskill wrote in a letter to the DEA Acting Administrator. “[The opioid crisis and enforcement] failures demand immediate action by Congress. As part of this effort, members of the Senate must have direct access to individuals—like Judge Mulrooney—with valuable knowledge of the [law] and its impact.”
After media reports indicated that the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 had dramatically restricted the DEA’s ability to crack down on opioid distributors suspected of wrongdoing, McCaskill introduced a bill to repeal the law. Her roundtable on November 28 will focus on restoring the DEA’s enforcement power over drug distributors, and McCaskill invited Judge Mulrooney to participate. In an upcoming article in the Marquette Law Review, Judge Mulrooney discusses how the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 hamstrings the DEA’s ability to hold opioid distributors accountable for wrongdoing. “Given [Judge Mulrooney’s] findings, and the unique expertise [he] has gained from years of adjudicating DEA administrative actions, I invited him to attend my forthcoming roundtable,” McCaskill wrote. “Shockingly, however, DEA has declined to grant permission for Judge Mulrooney to attend in his personal capacity and discuss his recent scholarship.” McCaskill is urging the DEA to reconsider its decision.
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 in July, 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.
Read McCaskill’s letter to the DEA Acting Administrator HERE.