Life Science Compliance Update

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August 07, 2017

McCaskill Opioid Investigation Expanding

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United States Senator Claire McCaskill recently announced that she is expanding her wide-ranging investigation into the causes of the current opioid epidemic by requesting information and documents from four additional pharmaceutical manufacturers and three opioid distributors.

Her requests focus on the distribution of opioids and the efforts leading companies have made to monitor, report, and investigate the diversion of drugs for illicit use. Drug diversion occurs when pharmaceutical products meant for legal use by individuals are transferred to others for illicit use, including through the black market.    

McCaskill’s newest requests for documents and information from opioid manufacturers were sent to Mallinckrodt, Endo, Teva, and Allergan, while a prior request to McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc., focused on their distribution of opioid products.

McCaskill has previously 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.

Initial Requests

McCaskill’s request to distributors McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc., included requests for documents and information such as:

  • Internal estimates received from outside vendors or consultants concerning the risk of diversion associated with opioid products. 
  • Any audits of incentive or compensation policies conducted internally or commissioned from outside consultants.
  • A list of any facilities for which the Drug Enforcement Administration (DEA) has suspended or revoked registrations since January 2012, including the date the DEA imposed the suspension or revocation, the reason for the suspension or revocation, and the length of the suspension.
  • Suspicious order notifications provided to DEA regarding opioid orders originating from Missouri.
  • Details of opioid shipments to any Missouri pharmacy, distributor, or other customer.
  • Any compensation provided, whether commission, incentive, or as a factor in a bonus, that is in any way derived or partially derived from revenue or profitability targets or expectations for sales of opioid products.

New Requests

In letters to Mallinckrodt, Endo, Teva, and Allergan, McCaskill requested:

  • Any suspicious order monitoring program implemented, including efforts to monitor, investigate, or report suspicious transactions between distributors and pharmacies and efforts to analyze information related to “chargeback” requests.
  • Any questionnaires sent to distributors regarding their anti-diversion and compliance efforts, and any responses to these questionnaires received.
  • Any other formal correspondence sent to or received from distributors concerning their obligations to monitor, investigate, and report suspicious orders.
  • Suspicious order notifications provided to DEA regarding opioid orders originating from Missouri.
  • Details of efforts to audit or investigate Missouri-based pharmacies, distributors, or other customers.

“This epidemic has reportedly arisen, in part, from the failure of opioid distributors to monitor the flow of hundreds of millions of painkillers to pharmacies across the United States and then on to the black market,” McCaskill wrote. “Under the Controlled Substances Act, drug distributors have an obligation to report suspicious orders of controlled substances, which include ‘orders of unusual size, orders deviating from a normal pattern, and orders of unusual frequency.’”

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