The Drug Enforcement Administration failed for more than a decade to stop distributors of opioids from flooding West Virginia with millions of pills, many of which ending up at rogue pharmacies, a congressional panel reported.
In a 324-page report, the House Energy and Commerce Committee outlined more than 100 ways the DEA and drug distributors failed to control the number of opioid pills that flowed into West Virginia — the state with the highest rate of overdose deaths in the U.S.
The committee, whose report followed an 18-month investigation, laid much of the blame with the three largest wholesale distributors in the U.S. — AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. — which shipped over 900 million doses of hydrocodone and oxycodone to West Virginia between 2005 and 2016.
Two regional distributors, Miami-Luken Inc. and H.D. Smith Wholesale Drug Co, a unit of AmerisourceBergen, also made inordinate shipments during that timeframe, according to the committee's report.
Executives from those five distributors testified before the Energy and Commerce Subcommittee on Oversight and Investigations in May, where only one of the corporate leaders — the chairman of Miami-Luken — admitted his company was at fault and contributed to the U.S. opioid crisis.
Distributors are required to report suspicious orders of controlled substances, like opioids, to the DEA, but the committee found a number of breakdowns in that process.
The investigation revealed opioid shipments in West Virginia that "shocked the conscience," the panel said.
For instance, distributors sent nearly 21 million opioid pills over 10 years to pharmacies in Williamson, W.V., where about 3,000 people live.
And in Kermit, W.V., home to only 406 people, distributors sent about 9 million opioid doses to pharmacies over two years.
Turning a blind eye
There were a number of warning signs that were ignored by both the DEA and the distributors, the committee said.
It found several cases where distributors had failed to conduct proper due diligence of their customers.
Even though the DEA tried to educate distributors about their responsibility to report suspicious orders, the companies failed to address monitoring in critical ways, the committee reported.
It said there were instances in which distributors appeared to turn a blind eye to the red flags of possible drug diversion or took only minimal steps to investigate, while continuing to ship controlled substances to suspect pharmacies.
Many of the suspect pharmacies highlighted in the report remain open, with some distributors continuing to do business with them, the committee said.
One of the greatest factors that hindered the DEA's ability to proactively identify diversion trends and target enforcement actions was the difficulty it had in using the data its collects through its Automation of Reports and Consolidated Orders System, or ARCOS, according to the report.
The system collects about 90 million transaction reports annually from registered manufacturers and distributors. The data are intended to help the DEA detect abnormal distribution patterns involving individual pharmacies and distributors or larger controlled substances sales trends across the U.S.
The DEA has made some recent improvements to ARCOS, but the system still has problems, the committee said.
The report laid out more than a dozen recommendations for the DEA and drug distributors to implement to fix their problems.
The report came two months after Congress passed a 660-page landmark bill aimed at addressing the U.S. opioid epidemic — measures that are expected to take years for the government to implement.
Probing conflicts of interest
Meanwhile, the top Democrat on the Senate Finance Committee, Sen. Ron Wyden of Oregon, pressed Health and Human Services Secretary Alex Azar over concerns about financial conflicts of interest with members of a task force charged with reviewing best practices for prescribing pain medications and making recommendations about what opioid-use disorder treatments should be covered by the government's healthcare programs for seniors, the disabled and low-income Americans.
The task force was created under a 2016 opioid bill, the Comprehensive Addiction and Recovery Act.
Wyden said 10 of the task force's members reported receiving payments totaling about $180,000 from drug and device companies, including opioid manufacturers, such as Pfizer Inc. and Purdue Pharma L.P.
He noted one of the members of the task force works at the U.S. Pain Foundation, which has taken money from several opioid makers, including Insys Therapeutics Inc., a company that has been the subject of civil and criminal prosecution for abusive marketing practices involving its fentanyl product.
In a separate letter, the Oregon senator also questioned the U.S. Pain Foundation about its ties to Insys and others opioid makers and the organization's patient assistance program.
New naloxone guidelines
The House report and Wyden's letters came on the same day HHS unveiled new prescribing guidelines for the opioid-overdose reversal agent naloxone.
The agency said clinicians should prescribe naloxone or co-prescribe it in conjunction with other medicines to people at risk for opioid overdose.
HHS advised clinicians to educate patients and those who are likely to respond to an overdose, including family members and friends, on when and how to use naloxone.
The guidelines were issued a day after an FDA advisory panel voted 12 to 11 in favor of prescribing naloxone with prescription opioid painkillers.