Following a request from Sen. Claire McCaskill (D-MO), the top-ranking Democrat on the Senate Committee on Homeland Security and Governmental Affairs, the Department of Justice Office of Inspector General (IG) has launched a review of the Drug Enforcement Administration’s (DEA) efforts to combat illegal opioid distribution through enforcement actions against opioid distributors.
The IG is assessing whether DEA’s regulatory activities and enforcement efforts effectively prevent the diversion of controlled substances, particularly opioids, to unauthorized users. Specifically, the IG’s review will examine: DEA’s enforcement policies and procedures to regulate registrants; DEA’s use of enforcement actions involving distributors of opioids who violate these policies and procedures; and DEA’s coordination with state and local partners in countering illicit opioid distribution.
Concerned about whether DEA is doing enough to investigate and prosecute the illicit diversion of opioids, Senate Committee on Homeland Security and Governmental Affairs Chairman Ron Johnson (R-WI) and McCaskill recently sent a letter to DEA Acting Administrator Charles P. Rosenberg requesting information regarding anti-diversion investigations conducted by the agency since 2011 in the wake of the opioid crisis, as Homeland Security Today earlier reported.
The lawmakers said in their letter that, “In 2015, when the committee examined allegations of opioid abuse at a VA facility in Tomah, Wisconsin, we learned that the DEA had been investigating allegations of diversion relating to the facility since at least 2009. Two years after news broke of the tragedies—and eight years since the DEA began its investigation—we are unaware of any administrative or criminal charges stemming from the tragedies at the Tomah VA facility.”
The two lawmakers said, “According to news reports … DEA has also been slow to target private pharmaceutical distributors … for example, when DEA agents ‘began to target wholesale companies that distributed hundreds of millions of highly addictive pills to the corrupt pharmacies and pill mills that illegally sold the drugs for street use,’ DEA officials at headquarters ‘began delaying and blocking enforcement actions.’ The DEA has also reportedly provided ‘conflicting guidance’ to a pharmaceutical company about its responsibilities to report suspicious orders from retailers. The conflicting guidance reportedly contributed to the government’s inability to obtain criminal convictions following its investigation.”
“DEA officials [also] may have presented conflicting guidance to a pharmaceutical manufacturer concerning its obligation to know its ‘customers’ customers,” they stated, asking Rosenberg to “describe any obligations manufacturers hold to monitor and report suspicious activity by pharmacies and doctors, the sources for these obligations under law or DEA regulations, and any related guidance the DEA has provided to manufacturers.”
DEA is instrumental in preventing and investigating diversion of controlled pharmaceuticals from both government and private facilities.
“I’ve had serious concerns that enforcement actions against opioid distributors have amounted to a slap on the wrist and the decision by the Department of Justice’s watchdog was a much-needed step,” McCaskill said. “We’re in the midst of a national epidemic—an epidemic that has taken the lives of thousands of Missourians—and if there’s clear evidence that distributors or manufacturers have acted illegally there needs to be every effort to hold them fully accountable.”
In March, McCaskill requested that the IG conduct an investigation into the ability of the DEA to hold major drug distributors accountable for opioid diversion. In her letter to the Department of Justice IG, McCaskill raised concerns that the fines recently levied against opioid distributors for major infractions were inadequate given the scale of the opioid problem within the United States and the severity of the infractions. McCaskill also questioned whether changes to DEA standards and pressure from senior officials have undermined enforcement efforts.
Earlier this year, McCaskill launched a wide-ranging investigation into opioid manufacturers to explore whether pharmaceutical manufacturers—at the head of the opioids pipeline—have contributed to opioid overutilization and overprescription as overdose deaths in the last fifteen years have approached nearly 200,000.