Concerned about whether the Drug Enforcement Administration (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 ranking member Claire McCaskill (D-MO), this week 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.
DEA is instrumental in preventing and investigating diversion of controlled pharmaceuticals from both government and private facilities.
The lawmakers said 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.”
“As the chief federal law enforcement agency responsible for enforcing the nation’s drug laws, the DEA has a duty to investigate violations of controlled substance laws. Accordingly, we write to request information about the DEA’s practices with respect to enforcement actions in anti-diversion investigations,” the lawmakers wrote Rosenberg.
“To assist the committee in better understanding how the DEA has pursued anti-diversion investigations during the opioid epidemic, we respectfully request the following information and material:
For each year since Fiscal Year 2011, please provide the following data relating to the DEA’s anti-diversion activities:
- The number of civil case filings against distributors, manufacturers, pharmacies and doctors;
- The number of immediate licensure suspension orders or orders to show cause against distributors, manufacturers, pharmacies and doctors;
- The number of voluntary license surrenders by doctors, including the number of such surrenders related to DEA enforcement actions; and
- The number of administrative enforcementactions brought against opioid distributors and manufacturers.
For eachentry, the lawmakers are seeking the identity of the entity, the date of the DEA’s action, the nature of the allegations and the disposition of the matter.
For each year since FY 2011, they’ve requested identification of all fines DEA has levied against distributors and manufacturers, including the amount, date and recipient of each fine.
For each year since FY 2011, they’ve asked DEA to provide a list of the number of reports to DEA from manufacturers and distributors concerning suspicious orders of pharmaceuticals, broken down by the individual manufacturer or distributor.
For each year since FY 2011, lawmakers also want all the following data relating to the DEA’s anti-diversion activities:
- The number of anti-diversion investigations relating to a Department of Veterans Affairs facility or doctor;
- The number of license suspensions or civil proceedings against a VA facility or doctor; and
- The number of criminal proceedings brought against a VA provider.
For each entry, they’ve also asked DEA to identify the relevant facility, date of the proceeding, the nature of the allegations and the disposition of the matter.
The lawmakers stated that “beginning in 2013, DEA attorneys ‘started requiring a higher standard of proof’ before civil cases could move forward. According to former officials, DEA leadership changed the burden of proof that investigators needed to meet before proceeding with administrative cases from a ‘preponderance of evidence’ to ‘beyond a reasonable doubt.’ Is this assertion accurate? If so, please explain the reasoning behind this change and provide supporting material.”
And, “If accurate,” the lawmakers stated, they asked DEA to “explain whether [it] received approval or guidance from the Department of Justice, including the Office of the Deputy Attorney General, before requiring a higher standard of proof before proceeding with administrative cases.”
Continuing, the lawmakers stated, “As mentioned above, DEA officials may have presented conflicting guidance to a pharmaceutical manufacturer concerning its obligation to know its customers’ customers.’ Please 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.”
Finally, they wrote, “When investigating a VA facility or provider, please explain the process by which the DEA obtains investigative information from the VA. Has the DEA ever experienced difficulties obtaining information from the VA necessary to complete an investigation? Please explain."
The lawmakers gave DEA “by no later than May 22, 2017” to respond, after which they said “the committee may seek a staff-level briefing at the appropriate time.”
