Mylan and the Department of Justice don’t seem to be on the same page these days.
On October 7, Mylan said agreed to pay $465 million to the Department of Justice and other government agencies over the way it classified the EpiPen in the Medicaid Drug Rebate Program. In the past few months, lawmakers have been accusing Mylan of overcharging Medicaid.
Mylan repeated the figure when it reported third-quarter earnings on Nov. 9. During a conference call with analysts that day, the company said it is still working with the DOJ to finalize that settlement.
That settlement doesn’t seem to be as concrete in the eyes of the DOJ. In a letter sent to Senator Chuck Grassley of Iowa, the assistant attorney general said the DOJ would not be able to testify at an upcoming hearing because “it hasn’t “agreed to any settlement with any potential party.” The hearing had been scheduled for November 30.
Mylan may think it is close to a settlement, but the DOJ won’t publicly back it up. To be fair, the DOJ won’t back up anything Mylan is saying right now. It also won’t even admit that it is looking into the matter, even though Mylan has said in SEC filings that it was subpoenaed back in November 2014.
Contacted by Business Insider, Mylan’s spokeswoman repeated what it has said about working to finalize the settlement.
Naturally, this is frustrating lawmakers. Sen. Elizabeth Warren has already torched the DOJ over the figure reported by Mylan, arguing that it’s lower than the law covering this kind of overcharging dictates.
“It’s hard to understand why the Justice Department won’t testify about allegedly hundreds of millions of dollars in overcharges to the taxpayers,” Grassley said in a statement. “Accountability requires getting answers about why the overcharges happened and what, if anything, is being done to make sure the taxpayers are repaid for their losses and to keep this from happening again.”
The back-and-forth over Medicaid classification isn’t not the only legal matter Mylan’s facing. The company’s also under investigation generic price collusion, unrelated to the EpiPen. For the sake of keeping everything straight, here are all the subpoenas Mylan’s disclosed, per its 10-Q.
What was disclosed in the third-quarter 10-Q
- We learned that the DOJ subpoenaed Mylan back in November 2014 over the classification of the EpiPen in the case that’s in the process of being settled. Mylan has also received a document request from the SEC about this classification issue and Mylan’s communications with the Centers for Medicare and Medicaid.
- Class action lawsuits on behalf of shareholders were filed in October 2016, alleging that Mylan “made false or misleading statements and omissions of purportedly material fact” regarding the classification of the EpiPen under Medicaid. Mylan said the lawsuits are without merit.
- Consumer class action lawsuits were also filed in August 2016 over the pricing and marketing of the EpiPen.
- Mylan’s also facing a shareholder lawsuit out of Israel as of October 13 2016, also regarding EpiPen’s classification under Medicaid. Mylan said this suit was also without merit.
- State attorneys general have subpoenaed Mylan for pricing and marketing information regarding EpiPen.
- Employees and one member of Mylan’s senior management on September 8, 2016 received subpoenas from the Department of Justice relating to the the marketing pricing and sale of some of Mylan’s generic products, as well as Mylan’s communications with its competitors. This is related to the reports that the DOJ is looking into generic drug price fixing.
- In September 2016, a class action case was filed in Pennsylvania regarding alleged price-fixing the cholesterol medication Pravastatin. Mylan noted that it intends to “deny liability.”
Investigations that were in the second-quarter 10-Q as well
- SEC investigation that started September 10, 2015 regarding “certain related party matters.”
- Mylan also received subpoenas in December 2015 from the Antitrust Division of the DOJ and the attorney general of Connecticut regarding the price and marketing of Doxycycline, an antibiotic.
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