WASHINGTON – Opioid manufacturers will be the subject of a new, wide-ranging investigation being launched by U.S. Senator Claire McCaskill, the top-ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee. McCaskill is requesting information from the manufacturers of the nation’s top five prescription opioid products by 2015 sales, including sales and marketing materials, internal addiction studies, details on compliance with government settlements and donations to third party advocacy groups.
The investigation will 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. According to the Centers for Disease Control and Prevention, deaths from opioids, including prescription opioids and heroin, reached over 30,000 in 2015 alone, and sales of prescription opioids have quadrupled since 1999.
“I hear it everywhere I go—drug overdose deaths, the vast majority of them related to prescription opioids or heroin, are single-handedly destroying families and communities across Missouri and the country, and I refuse to just stand by and watch—we have an obligation to everyone devastated by this epidemic to find answers,” McCaskill said. “All of this didn’t happen overnight—it happened one prescription and marketing program at a time. The vast majority of the employees, executives, sales representatives, scientists, and doctors involved with this industry are good people and responsible actors, but some are not. This investigation is about finding out whether the same practices that led to this epidemic still continue today, and if decisions are being made that harm the public health.”
In letters to the heads of Purdue, Janssen/Johnson & Johnson, Insys, Mylan, and Depomed, McCaskill requested:
- Documents showing any internal estimates of the risk of misuse, abuse, addiction, overdose, diversion or death arising from the use of any opioid product or any estimates of these risks produced by third-party contractors or vendors.
- Any reports generated within the last five years summarizing or concerning compliance audits of sales and marketing policies.
- Marketing and business plans, including plans for direct-to-consumer and physician marketing, developed during the last five years.
- Quotas for sales representatives dedicated to opioid products concerning the recruitment of physicians for speakers programs during the last five years.
- Contributions to a variety of third party advocacy organizations.
- Any reports issued to government agencies during the last five years in accordance with corporate integrity agreements or other settlement agreements.
“This epidemic is the direct result of a calculated sales and marketing strategy major opioid manufacturers have allegedly pursued over the past 20 years to expand their market share and increase dependency on powerful—and often deadly—painkillers,” McCaskill wrote. “To achieve this goal, manufactures have reportedly sought, among other techniques, to downplay the risk of addiction to their products and encourage physicians to prescribe opioids for all cases of pain and in high doses.”
Earlier this year McCaskill requested that the Department of Justice Office of Inspector General conduct an investigation into the Drug Enforcement Administration’s capacity to oversee drug distributors and their role in curbing opioid abuse.
When McCaskill was ranking member of the Permanent Subcommittee on Investigations, she joined Subcommittee Chairman Rob Portman to launch an investigation into the role Medicare Part D entities, private insurers, and pharmacy benefit managers play in detecting, reporting, and addressing opioid abuse, resulting in the in-depth report, Combatting the Opioid Epidemic: A Review of Anti-Abuse Efforts in Medicare and Private Health Insurance Systems.
During McCaskill’s time as the top Democratic on the Senate Special Committee on Aging, she joined Committee Chairman Susan Collins to launch an in-depth investigation into prescription drug price increases. Last year, Collins and McCaskill wrote to top naloxone producers for information on how they’ll work to keep naloxone—the opioid reversal drug—available. Last month, McCaskill continued these efforts, demanding answers from Kaleo Pharmaceuticals on why their naloxone price has risen from $690 to $4,500 between 2014 and now.
McCaskill has also been a leading voice in urging Missouri to join the rest of the 49 states in adopting a prescription drug monitoring system (PDMP) to help control growth of prescription drug abuse. Last year, her efforts ensured that the Comprehensive Addiction and Recovery Act included provisions to allow local governments operating in a state without a PDMP to apply for HHS grants. That summer, McCaskill and then-Agriculture Secretary Tom Vilsack hosted a series of events in Missouri to discuss cities’ ability to apply for these grants. McCaskill also held a field hearing in Jefferson City urging lawmakers to start a prescription drug monitoring system (PDMP). She has worked this year with local officials to secure funding for their local PDMPs.
A fact-sheet detailing the scope of the opioid epidemic and previous examples of inappropriate and illegal action from opioid manufacturers is available HERE.
Read McCaskill’s letters to the heads of Purdue, Janssen/Johnson & Johnson, Insys, Mylan, and Depomed HERE.