Mylan paying $465M to settle claims it overcharged for EpiPens

Xavier Trudeau
Août 17, 2017

The government contends that Mylan improperly avoided paying state Medicaid programs the higher rebates for branded drugs by misclassifying the EpiPen as a generic drug, even though the EpiPen had no FDA-approved therapeutic equivalents and even though Mylan marketed and priced the EpiPen as a brand name drug. The deal had sparked criticism from some USA lawmakers who said it wasn't tough enough on the company.

Mylan came under fire past year after raising the price of a pair of EpiPens to $600, from $100 in 2008, enraging consumers and putting it in the center of the ongoing US debate over the high cost of prescription medicines. A recent government report found that taxpayers may have overpaid for EpiPen by as much as $1.27 billion over the last decade.

Mylan shares rose 2.10 percent to $31.11 on the Nasdaq. Over the course of the a year ago, we have taken significant steps to enhance access to epinephrine auto-injectors, including bringing a solution to the fast-changing healthcare landscape in the launching an authorized generic version at less than half the wholesale acquisition cost of the brand and meaningfully expanding our patient access programs. Mylan will reclassify EpiPen Auto-Injector for purposes of the Medicaid Drug Rebate Program and pay the rebate applicable to innovator products effective as of April 1, 2017.

Many parents and schools buy up the epinephrine injectors each fall to make sure children can stave off anaphylactic shock, so lawmakers took notice last fall.

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. At the time, Sanofi was selling a competing auto-injector and was reporting it to Medicaid as a brand-name drug, the government said. 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. Sanofi will receive $38.7 million as its share, plus a share of the states' recovery. "Medicaid will no longer be overcharged for EpiPen, protecting access for Medicaid beneficiaries who rely on this lifesaving drug while saving hundreds of millions of dollars".

"Our five-year corporate integrity agreement requires intensive outside scrutiny to assess whether Mylan is complying with the rules of the Medicaid Drug Rebate Program", said Gregory E. Demske, Chief Counsel to the HHS Inspector General. The settlement also funds Medicaid programs in all states and creates a framework for resolving reimbursement claims.

In a statement, Mylan said the settlement does not include an admission of wrongdoing.

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