Teva Pharmaceutical Industries Ltd. has been hampering a Senate investigation into the role that drugmakers and distributors have played in driving the opioid epidemic plaguing the U.S., Sen. Claire McCaskill, D-Mo., charged.
McCaskill, ranking member on the Senate Homeland Security and Government Affairs Committee, said Teva refused to turn over information related to the probe, which "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," McCaskill said.
The Missouri lawmaker's accusation came on the same day that the Centers for Disease Control and Prevention reported that visits to U.S. hospital emergency rooms for suspected opioid overdoses have shot up 30% across the nation.
McCaskill launched her investigation last year, seeking information from several drugmakers, including Purdue Pharma LP, Johnson & Johnson, Mylan NV, Insys Therapeutics Inc., Depomed Inc., Endo International PLC and Allergan PLC, about their sales and marketing materials, internal addiction studies, details on compliance with government settlements and donations to third-party advocacy groups.
She also requested information from distributors McKesson Corp., AmerisourceBergen Corp. and Cardinal Health Inc.
But McCaskill said: "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."
Teva responds
Teva spokeswoman Kaelan Hollon told S&P Global Market Intelligence that the company shared McCaskill's concern about opioid abuse and noted that the drugmaker has held "multiple meetings" with the senator's senior staff "in an effort to provide information that would assist in identifying collaborative solutions to this national crisis."
Teva's lawyer, James Matthews of Foley and Lardner LLP, also said that the company had engaged in several communications with the senator or her staff, including a 90-minute discussion in July 2017 when the company went "into depth about channels of distribution and practices and methods for identifying, investigating and reporting potentially suspicious orders."
In an Oct. 5, 2017, letter to the senator, Matthews had said that Teva's lengthy discussions had "fully and fairly covered virtually all" of the topics at "an appropriate level of detail" on the matters for which McCaskill was seeking information.
He acknowledged, however, that the company had declined to produce the documents the senator had specifically requested.
"We do not believe that these specific documents will advance your stated goal: 'to understand the role of manufacturers and distributors in overseeing opioid shipments and preventing diversion,'" Matthews wrote.
"It seems likely that publicly disclosing specific and sensitive proprietary information about Teva's customers will chill the willingness of such customers to share information with your committee and participate in our collective efforts to address opioid abuse," he said.
Matthews argued that McCaskill had access to much of the information she was seeking through the U.S. Drug Enforcement Administration, or DEA, which was in the "best position to make decisions about the appropriateness of disclosing such sensitive information publicly."
The records McCaskill had requested could, if publicly released, be potentially misused in pending litigation brought by states and municipalities against drugmakers — lawsuits that were "without merit," Matthews said.
"These suits stand as an obstacle to constructive dialogue and collaborative efforts aimed at addressing opioid addiction, wasting time and money on litigation that could be better spent working together to find effective solutions," he said. "In such an environment, Teva has a responsibility to be judicious in determining what documents and information to release publicly."
Power to act
As the ranking member of the Senate Homeland panel, McCaskill lacks the power to compel Teva to cooperate with her demands, and the chairman of the committee, Sen. Ron Johnson, R-Wis., refuses to subpoena the Israeli company.
So for now, it is unclear what more McCaskill can do to get Teva to turn over the documents she is seeking.
President Donald Trump, however, last week insisted that pharmaceutical companies that helped fuel the opioid epidemic should face federal litigation.
Attorney General Jeff Sessions revealed Feb. 27 that the U.S. Department of Justice planned to file a so-called statement of interest in a lawsuit against a number of drug manufacturers and distributors accused of using false, deceptive and unfair marketing practices.
In its March 1 request, the Justice Department asked Judge Dan Polster of the U.S. District of the Northern District of Ohio in Cleveland, who is overseeing more than 350 lawsuits brought by various municipalities, to give the federal government 30 days to decide whether to participate in the litigation.
Meanwhile, Sen. Joe Manchin, D-W.V., introduced legislation aimed at restoring certain authorities to the DEA so it can better rein in drugmakers and distributors selling large numbers of opioid pills to rogue pharmacies and doctors — powers that were weakened under a 2016 law.
That law was co-authored by Rep. Tom Marino, R-Pa., who Trump initially picked to lead the White House Office of National Drug Control Policy, or ONDCP — the nation's drug czar.
Marino withdrew from the nomination in October 2017 after a public outcry when a news investigation revealed his law had impeded the DEA's ability to stop opioids from flooding several communities.
The ONDCP is now being run by James Carroll, who is overseeing the office in an acting capacity while awaiting Senate confirmation.
In a March 5 statement, Manchin said his bill would amend the "substantial likelihood" standard to a "probable cause" standard and would strike the provisions that added the option of a "corrective action plan," which the lawmaker said has slowed down the DEA's ability to suspend suspicious opioid orders.