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Senator Launches Investigation of Top Five Opioid Drug-Makers
Opioid manufacturers are the subject of an investigation launched by Senator Claire McCaskill (D-Missouri), the top-ranking Democrat on the Senate’s Homeland Security and Governmental Affairs Committee. McCaskill has requested information from the manufacturers of the nation’s top five prescription opioid products, 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. According to the Centers for Disease Control and Prevention, deaths from opioids, including prescription opioids and heroin, reached more than 30,000 in 2015, 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. … 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 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
- 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 third-party advocacy organizations
- 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 Office of Inspector General at the Department of Justice conduct an investigation into the Drug Enforcement Administration’s capacity to oversee drug distributors and their role in curbing opioid abuse.
Source: HSGAC; March 28, 2017.