In Summer 2017, we wrote about Senator Claire McCaskill’s request to Teva Pharmaceutical Industries that they provide information about the distribution of opioids and its efforts to prevent drug diversion. In her original letter, McCaskill stated, “[t]his 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.”
In her initial letter, she requested several documents and pieces of information to “aid the Committee in understanding the role of manufacturers and distributors in overseeing opioid shipments and preventing diversion.” Included in that request were: descriptions of any suspicious order monitoring program Teva and its subsidiaries have implemented; copies of any questionnaires (and any responses to same) sent to distributors by Teva and its subsidiaries regarding their anti-diversion and compliance efforts; a list of all suspicious order notifications Teva and its subsidiaries provided to DEA regarding opioid orders originating from Missouri; and a list of all Missouri-based pharmacies, distributors, or other customers for which Teva and its subsidiaries have conducted an audit or investigation.
In response, Foley & Lardner, LLP, Teva’s attorneys, sent her a letter essentially telling McCaskill that they were not going to comply with any of her requests. The one response Teva provided through its attorneys were that it does maintain “robust anti-diversion systems and procedures,” and then described them in general detail.
McCaskill responded to the Teva response less than a month later, noting Teva’s lack of specific responses to her requests or requests for information issued by her Staff. In her letter, McCaskill also notes – interestingly – that Teva is the only company who received one of these letters from her office that has indicated “it will refuse to cooperate fully with this inquiry.” Other companies that received letters from McCaskill requesting information regarding their opioid prescribing practices or distribution of such products included Mallinckrodt, Endo, Allergan, McKesson Corporation, and Cardinal Health, Inc.
Then, on October 5, 2017, Foley & Lardner reiterated its recognition of “the pressing issue of prescription opioid abuse in the United States,” expressed its commitment to “working with leaders in government, the healthcare community, and the non-profit sector to address this crucial public health concern.” Throughout the letter, Teva references multiple discussion with McCaskill and/or her staff, which it often cites as reasons for not publicly disclosing the information McCaskill requests. Teva notes that it remains firm in its belief that its refusal to publicly release the documents, as a public disclosure of specific and sensitive proprietary information may “chill the willingness” of its customers to share information with the Committee and participate in larger efforts to address opioid abuse.
While it seemed for several months that Teva’s non-response was going to be the last in this investigation, on Tuesday, March 6, 2018, Senator McCaskill brought up the issue once again, noting,
“Teva’s refusal to cooperate with Congressional requests strongly suggests they have something to hide. I’d hope that everyone involved or associated with the company takes note that they’re dealing with an entity that’s stonewalling a Senate investigation examining a national public health crisis. Teva has been an outlier throughout our investigation, and they can rest assured that I’ll continue to pursue every possible avenue to get them to comply for as long as it takes.”
This saga does not seem to be ending anytime soon, especially since Teva is headquartered in McCaskill’s home state of Missouri. We will keep our eye on this continuing back-and-forth, and provide updates as they arise and change the course of the discussion.
In another act related to industry, there is talk that McCaskill is planning to introduce a bill that would toughen the Sunshine Act by requiring drug makers to report payments that are made to nonprofit organizations and patient advocacy groups. We will do our best to keep up with any developments in this as they arise.