WASHINGTON, DC - The Energy and Commerce Committee, chaired by Rep. Greg Walden (R-OR), today released a report summarizing its findings after concluding its bipartisan investigation into allegations of opioid-dumping in West Virginia. The Subcommittee on Oversight and Investigations, chaired by Rep. Gregg Harper (R-MS), spent more than 18 months investigating large quantities of opioids sent to rural towns.
“The Energy and Commerce Committee spent more than 18 months investigating allegations of pill dumping in West Virginia - the epicenter of the nation’s opioid epidemic and the state with the highest drug overdose death rate in the country," said Chairman Greg Walden and Ranking Member Frank Pallone, Jr. (D-NJ). “Our bipartisan investigation revealed systemic failures by both distributors and the DEA that contributed to-and failed to abate-the opioid crisis in West Virginia. The Majority Staff Report released today identified several flaws limiting the effectiveness of the distributors’ compliance programs and DEA’s enforcement. While we’ve already been hard at work this Congress to combat the opioid crisis with the signing of H.R. 6 into law, more work remains."
“Our bipartisan investigation revealed a number of alarming failures by the DEA and drug distributors to address the opioid epidemic," said #SubOversight Chairman Harper. “In instances identified by the committee’s report, DEA and the drug distributors did not meet their obligations, and played a part in contributing to our nation’s opioid crisis. My hope is the legislative solutions outlined in this report will be enacted so we can better protect communities in West Virginia and across the country."
The report details numerous warning signs and red flags missed by wholesale drug distributors and the Drug Enforcement Administration (DEA) that contributed to the worsening of the opioid epidemic in West Virginia. The report concludes with a series of recommendations and suggested legislative solutions to help improve the effectiveness of the distributors’ compliance programs and the DEA’s enforcement.
The recommendations include:
* Congress should consider enacting additional suspicious order requirements to clarify registrant responsibilities and to supplement the suspicious order requirements recently codified in the SUPPORT Act;
* DEA should work to establish a data platform with third-party experts to provide more real-time data to registrants;
* DEA should establish guidance on delaying Immediate Suspension Orders or other administrative actions for the furtherance of parallel criminal investigations, including a limit on the amount of time the agency will delay action;
* As part of their prospective customer due diligence, and at regular intervals thereafter, distributors should require the production of dispensing data from a pharmacy, preferably in a manner that would enable the distributor to identify the pharmacy’s prescribing physicians;
* When red flags are raised and documented regarding a pharmacy, that pharmacy should be subject to heightened monitoring. Distributors’ policies should specify the frequency and type of any such heightened monitoring; and
* Distributors’ policies should clearly require a proactive review of pharmacies that share common ownership with a pharmacy terminated for compliance reasons within a reasonable, and determined, amount of time, among other recommendations.
The report concludes, “Blame for the opioid epidemic is widespread and goes far beyond the bounds of this investigation. Pharmaceutical manufacturers, pharmacists, physicians, drug traffickers, and others have contributed to this problem as well. This investigation has revealed that neither the DEA nor the distributors rose to the occasion to help mitigate the opioid epidemic. The committee will continue its bipartisan work to examine the causes and effects of the opioid epidemic."
Background
In May 2017, the committee opened a bipartisan investigation into the distribution of prescription opioids by wholesale drug distributors, with a specific focus on distribution practices in West Virginia, and enforcement practices by the DEA during the opioid epidemic.
Bipartisan committee leaders sent letters to the top drug distributors (AmerisourceBergen Corporation, CardinalHealth, Inc., and McKesson Corporation) and the DEA in May 2017, regarding reports of extremely high amounts of opioids being distributed in the state. Cited in the letters was the example of Kermit, West Virginia, population 406, receiving nearly 9 million hydrocodone pills in a two-year period.
Bipartisan committee leaders probed a fourth distributor, Miami-Luken, Inc., in September 2017 and sent a follow up letter to the DEA in October 2017. During October 2017, the full committee held a hearing where Chairman Walden grilled the DEA on its lack of cooperation and response to the committee’s investigation.
In January 2018, bipartisan committee leaders sent a follow up letter to Miami-Luken and probed a fifth distributor, H.D. Smith Wholesale Drug Co.
In February 2018, bipartisan committee leaders sent follow-up letters to McKesson, Cardinal Health, and AmerisourceBergen.
In March 2018, #SubOversight held a hearing examining the DEA’s role in combating the opioid crisis.
In May 2018, #SubOversight held a hearing with the leadership of national and regional drug distributors to testify about their role in the opioid crisis.
