Life Science Compliance Update

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April 13, 2017

McCaskill Opens Investigation into Opioid Manufacturers

Claire McCaskill

Senator Claire McCaskill, Ranking Member of the Senate’s Homeland Security and Governmental Affairs Committee, has launched a wide-ranging investigation into the business practices of the manufacturers of America’s top five prescription opioid products (based on 2015 sales). The investigation is slated to explore whether pharmaceutical manufacturers have contributed to the opioid epidemic with which America is currently dealing.

Senator McCaskill sent letters to Purdue, Janssen (parent company: Johnson & Johnson), Insys, Mylan, and Depomed, asking for information related to the sale, marketing, and education strategies these companies have used to promote opioids. She is asking for information, including:

  • 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 speaker programs during the last five years;
  • Contributions to a variety of third party advocacy organizations; and
  • Any reports issued to government agencies during the last five years in accordance with corporate integrity agreements or other settlement agreements.

McCaskill Has Long Been Involved in the Epidemic

This is not McCaskill’s first effort in attempting to uncover what has contributed to this epidemic. Earlier this year, she requested the Department of Justice Office of the Inspector General open an investigation into the role of drug distributors in the opioid epidemic. She's also been involved in investigating Medicare Part D's role in preventing abuse of prescription narcotics.

“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,” McCaskill said in a statement.

“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,” McCaskill said. “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.”

Manufacturer Response

John Puskar, the spokesman for Purdue Pharma (manufacturer of OxyContin), said in an email that the “the opioid crisis is among our nation’s top health challenges, which is why our company has dedicated itself for years to being part of the solution. OxyContin accounts for only 2% of the opioid analgesic prescription market nationally, but we are an industry leader in the development of abuse-deterrent technology and advocating for the use of prescription drug monitoring programs. We are reviewing Senator McCaskill’s letter and will respond accordingly.”

Jessica Castles Smith, the spokeswoman for Janssen (owned by Johnson & Johnson), said in an email that the company would address McCaskill’s request. She said the company believes it has “acted appropriately, responsibly and in the best interests of patients regarding our opioid pain medications, which are FDA-approved and carry FDA-mandated warnings about the known risks of the medications on every product label.”

Christopher Keenan, the spokesman for Depomed, said the company has received McCaskill’s letter and “will cooperate accordingly.”

Nina Devlin, the spokeswoman for Mylan, called on McCaskill to include more opioid suppliers and said the company was only the 17th biggest opioid supplier in 2016, noting that, “[d]espite being a small player in this area, we are committed to helping find solutions to the issue of opioid abuse and misuse.”

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