Mylan, U.S. finalize $465 million EpiPen settlement

[Eugene]

Source: Reuters

#BUSINESS NEWS AUGUST 17, 2017 / 10:35 AM / AN HOUR AGO

Mylan, U.S. finalize $465 million EpiPen settlement

Nate Raymond
3 MIN READ

BOSTON (Reuters) - Mylan NV (MYL.O) has finalized a $465 million settlement with the U.S. Justice Department, resolving claims it overcharged the government for its EpiPen emergency allergy treatment, which became the center of a firestorm over price increases.

The U.S. Attorney's Office in Massachusetts revealed the accord on Thursday, 10 months after Mylan said it reached a deal resolving claims it misclassified the EpiPen as a generic rather than a branded product to avoid paying rebates owed to Medicaid.

"Taxpayers rightly expect companies like Mylan that receive payments from taxpayer-funded programs to scrupulously follow the rules," Acting U.S. Attorney William Weinreb said in a statement.

Mylan did admit wrongdoing in entering into the settlement.

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Read more: http://www.reuters.com/article/us-mylan-epipen-idUSKCN1AX1RW

[nitpicker]

1. From the DoJ PR

https://www.justice.gov/usao-ma/pr/mylan-agrees-pay-465-million-resolve-false-claims-act-liability

BOSTON – The U.S. Attorney’s Office announced today that pharmaceutical companies Mylan Inc. and Mylan Specialty L.P. have agreed to pay $465 million to resolve allegations that they violated the False Claims Act by knowingly misclassifying EpiPen, a branded epinephrine auto-injector drug, as a generic drug to avoid paying rebates owed to Medicaid. Mylan Inc. and Mylan Specialty L.P. are both wholly owned subsidiaries of Mylan N.V., a Dutch-registered entity headquartered in Canonsburg, Penn.

Congress enacted the Medicaid Drug Rebate Program to ensure that state Medicaid programs were not susceptible to price gouging by manufacturers of drugs that were available from only a single source. It therefore subjected such single-source, or brand name drugs, to a higher rebate that includes any difference between the drug’s current price and the price the drug would have had if its price had increased only at the general rate of inflation. In contrast, generic drugs originating from multiple manufacturers are subject to lower rebates that, at least until recently, did not include an inflationary component.

The government contends that Mylan improperly avoided paying state Medicaid programs the higher rebates for branded drugs by misclassifying EpiPen as a generic drug, even though EpiPen had no FDA-approved therapeutic equivalents and even though Mylan marketed and priced EpiPen as a brand name drug. Mylan raised the price of EpiPen by approximately 400% between 2010 and 2016.
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A competing pharmaceutical manufacturer, Sanofi, raised this matter with the United States Attorney’s Office in 2014. At the time, Sanofi was selling another epinephrine auto-injector drug called AUVI-Q and was reporting it to the Medicaid Drug Rebate Program as a brand name drug. In 2016, Sanofi filed a complaint against Mylan under the qui tam provisions of the False Claims Act, which permits private parties to sue on behalf of the government and to receive a share of any recovery. See United States ex rel. sanofi-aventis US LLC v. Mylan Inc., et al., No. 16cv11572 (D. Mass.). As a result of today’s settlement, Sanofi will receive $38.7 million as its share of the federal recovery, plus a share of the states’ recovery.
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