WASHINGTON – U.S. Senator Claire McCaskill, the top-ranking Democrat on the Homeland Security and Governmental Affairs Committee, today released the latest product of her wide-ranging investigation into opioid manufacturers and distributors. “Fueling an Epidemic: A Flood of 1.6 Billion Doses of Opioids into Missouri and the Need for Stronger DEA Enforcement” describes how the “Big Three” pharmaceutical distribution companies together shipped around 1.6 billion dosage units of opioid products to Missouri alone between 2012 and 2017. This volume of opioids represents more than 260 dosage units for every Missourian during the six-year period. In 2015—the peak year for opioid shipments to Missouri during the years investigated—the three major distributors shipped approximately 52 opioid dosage units per person in the state.
McCaskill’s report is the most comprehensive look ever taken at the volume of opioids that move through Missouri. The report highlights the number of suspicious orders reported as a result of that volume of opioids—as well as the lack of administrative enforcement action taken by the Drug Enforcement Administration (DEA) against distributors in general to prevent the diversion of opioids to the black market.
“It’s staggering. Over six years we averaged 260 pills for every man, woman, and child in Missouri,” McCaskill said. “The opioid crisis these pills have fueled is a failure of policy and oversight by the government and a failure of basic human morality on the part of many pharmaceutical companies and distributors—a failure that has destroyed families and communities all over our state.”
READ THE REPORT: Fueling an Epidemic: A Flood of 1.6 Billion Doses of Opioids into Missouri and the Need for Stronger DEA Enforcement
The report stems from requests McCaskill made to distributors McKesson, AmerisourceBergen, and Cardinal Health as well as opioid manufacturers Allergen, Endo, Mallinckrodt, and Teva. While many of these companies have cooperated with McCaskill’s requests, Teva has continually refused to comply with her investigation, and Allergan responded with limited information after months of delay.
The report’s key findings include:
· McKesson, AmerisourceBergen, and Cardinal Health—who each recorded 2017 revenue in excess of $125 billion and ranked within the top 15 companies on the 2017 Fortune 500—shipped around 1.6 billion dosage units of opioid products to Missouri alone between 2012 and 2017.
· This volume of opioids equated to more than 260 dosage units for every man, woman, and child in Missouri during the six-year period. During 2015—the peak year for opioid shipments to Missouri from 2012 to 2017—the three major distributors shipped approximately 52 opioid dosage units per person in the state.
· These “big three” distributors have also consistently failed to meet their suspicious opioid order reporting obligations over the past ten years—in some cases surrendering licenses for distribution facilities and paying escalating fines after DEA and Department of Justice investigations.
· In general, data suggests significant opioid prescribing and black-market diversion activity occurs in the Missouri counties to the south and southwest of St. Louis and in counties along the Missouri-Arkansas border—particularly Barry, Howell, and St. Francois counties.
“Missouri ranks 14th among the 50 states in terms of grams of hydrocodone and oxycodone distributed per 100,000 state residents in 2016. And according to the St. Louis County drug monitoring program, county physicians prescribe enough painkillers per month to provide every resident with three pills,” the report states.
McCaskill’s report also examines the efforts opioid distributors and manufacturers have undertaken to meet their obligations under the Controlled Substances Act to monitor and report suspicious orders to DEA, as well as the resulting number of reports of suspicious Missouri orders between 2012 and 2017. Despite the highly sophisticated methods and significant resources the three major distributors have deployed, their suspicious order reporting for Missouri orders between 2012 and 2017 varied widely.
McKesson and AmerisourceBergen, for example, both shipped around 650,000,000 dosage units to Missouri in this six-year period, but McKesson reported 16,714 suspicious orders to DEA while AmerisourceBergen reported only 224—around 75 times fewer reports than McKesson. Although Cardinal Health shipped fewer than half of the total opioid dosage units AmerisourceBergen distributed to Missouri between 2012 and 2017, it reported 5,125 suspicious orders to DEA—or almost 23 times more reports than AmerisourceBergen. The total suspicious orders McKesson reported also far exceed both the AmerisourceBergen and Cardinal Health totals, despite the fact that the McKesson total only reflects company reporting to DEA between August 2013 and December 2017. Among pharmaceutical manufacturers, Mallinckrodt reported 905 Missouri orders to DEA compared to no orders reported from Endo between 2012 and 2017.
Last year, McCaskill launched an investigation into opioid manufacturers—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. Later, she expanded her investigation, 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 of last year, McCaskill announced the first round of findings, detailing systemic manipulation of the prior authorization process by Insys Therapeutics. After media reports indicated that the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 had dramatically restricted DEA’s ability to crack down on opioid distributors suspected of wrongdoing, McCaskill introduced a bill to repeal the law, and she led a Senate roundtable on her bill. Earlier this year in February, McCaskill’s investigation released another round of findings, exposing the financial ties between opioid manufacturers and third party groups, who often lobbied for pro-opioid policies after receiving contributions from pharmaceutical companies. In the wake of these discoveries, McCaskill introduced a bill in June to increase transparency and make sure opioid manufacturers report contributions to third party groups, which totaled almost $9 million between 2012 and 2017 for the companies and groups profiled in the February 2018 report.
In May, McCaskill released a report showing a dramatic surge in fentanyl seizures at ports of entry by the Department of Homeland Security over the last several years. Another McCaskill report, released later that month, revealed a concurrent increase in fentanyl seizures by the Border Patrol inside the United States.
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