- In response to climbing numbers of deaths and rising sales of prescription opioids, U.S. Senator Claire McCaskill of the Senate Homeland Security and Governmental Affairs Committee has launched an investigation into the manufacturers of the top five opioids by 2015 sales, to understand their role in opioid overuse and overprescribing.
- McCaskill has written to Purdue Pharma, Johnson & Johnson, Insys, Mylan, and Depomed. The committee is requesting access to internal estimates of the risk of abuse or death, compliance audits, marketing and business plans, quotas for sales reps, contributions to advocacy organizations and reports to government agencies.
- Earlier in 2017, McCaskill requested a Department of Justice Officer of the Inspector General investigation into the Drug Enforcement Administration's capacity to oversee drug distributors and their role in curbing opioid abuse.
Opioid deaths are climbing in the U.S., whether through deliberate or accidental overdose. In 2015 alone, according to the Centers for Disease Control and Prevention, there were over 33,000 deaths due to opioid abuse and almost half of these involved a prescription drug.
“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,” U.S. Senator Claire McCaskill said in her letter.
Sales of opioids have quadrupled since 1999, and Senator McCaskill, who is the top-ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, wants to understand whether the pharmaceutical manufacturers have done what they should, or whether they have actually played a part in this increase, though perhaps it appears by her statement that this is exactly where she is laying the blame.
"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, manufacturers 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. 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 a statement to BioPharma Dive, Mylan expressed its concern about the epidemic and surprise at being included in this cohort of companies.
"We welcome the Senator’s interest in this important matter and we share her concerns regarding the misuse of prescription opioids. We very much hope that the Senator expands her interest to include the top ten suppliers of opioid drugs to the U.S. market. In 2016, Mylan ranked as the number 17 supplier of opioids sold in the U.S., representing approximately 1% of the entire U.S. opioid market. Despite being a small player in this area, we are committed to helping find solutions to the issue of opioid abuse and misuse," said Mylan via email.
Both Purdue and Depomed told BioPharma Dive in statements that the company is currently reviewing Senator McCaskill’s letter and will respond and cooperate accordingly.