- Reuters/Aaron P. Bernstein
A Senate investigation into whether or not big pharmaceutical companies had a hand in starting America’s current opioid epidemic just got wide.
Senator Claire McCaskill (D-MO) will now add drugmakers Mallinckrodt, Endo, Teva, and Allergan to the probe, as well as distributors AmerisourceBergen Corporation, and Cardinal Health, Inc.
“We’ve seen numerous reports that potentially hundreds of millions of opioid pills wound up on the black market, fueling a nationwide epidemic-we need a better understanding of how committed these companies are to preventing this type of drug diversion or whether they are turning a blind eye,” McCaskill said in a press release. “The people of Missouri and the countless families affected by this epidemic across the country deserve to find out everything possible about the root causes of this crisis.”
This spring McCaskill announced a probe into drugmakers Purdue, Johnson & Johnson, Mylan, and Depomed. The point is to see whether or not the companies encouraged the off-label use of opioid painkillers, and understand how they were marketed to physicians.
Now Mallinckrodt, Endo, Teva, and Allergan will have to produce the following documents:
- 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.
And distributors McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc., will have to produce the documents listed below:
- 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.