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Mylan Announces $465 Million Settlement Over Whether Epipen Qualifies as Generic

The Free Press WV

The pharmaceutical company Mylan has announced a $465 million settlement agreement with the U.S. Department of Justice over its EpiPen auto-injector products.

The conflict was over whether Mylan misclassified EpiPen as generic to avoid paying Medicaid rebates to the federal government.

Under the settlement, Mylan will reclassify EpiPen for purposes of the Medicaid Drug Rebate Program and pay the rebate applicable to innovator products, effective as of this past April 01.

Mylan had earlier indicated that a settlement was reached but today was the first day it was confirmed by the government.

As Bloomberg reported, some U.S. lawmakers criticized the deal as not tough enough on the company.

“As we said when we announced the settlement last year, bringing closure to this matter is the right course of action for Mylan and our stakeholders to allow us to move forward,” Mylan chief executive officer Heather Bresch stated in a news release.

“Over the course of the last year, we have taken significant steps to enhance access to epinephrine auto-injectors, including bringing a solution to the fast-changing healthcare landscape in the U.S. by launching an authorized generic version at less than half the wholesale acquisition cost of the brand and meaningfully expanding our patient access programs.”

Bresch is the daughter of Senator Joe Manchin, D-WV, and Gayle Manchin, the secretary of Education and the Arts in Governor Jim Justice’s administration.

She and Mylan have been under scrutiny over the price of Epi-Pen for much of this past year. Mylan acquired the rights to the shot-delivered medicine in 2007 and then raised the price roughly six-fold.

“Mylan has always been committed to providing patients in the U.S. and around the world with access to medicine, and we look forward to continuing to deliver on this mission,” Bresch said in the news release.

The settlement does not contain an admission or finding of wrongdoing.

Mylan also has entered into a Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services.

The settlement provides resolution of potential Medicaid rebate liability claims by the federal government, as well as by some hospitals and other covered entities, such as rival drugmaker Sanofi, which sued Mylan last year.

“It was our contention that Mylan’s intentional misclassification of EpiPen allowed them to amass hundreds of millions of dollars which they then used to finance their anticompetitive behavior in the marketplace,” Sanofi said in a statement Thursday.

The settlement allocates money to the Medicaid programs of all 50 states and establishes a framework for resolving all potential state Medicaid rebate liability claims within 60 days.

Medicaid gets a 23 percent discount on brand-name drugs and a 13 percent discount on generics.

The Centers for Medicare and Medicaid Service indicated that EpiPen had been classified incorrectly as a generic since at least 1997, both by Mylan and previous makers.

The Justice Department claimed in its lawsuit that by misclassifying EpiPen as a generic product rather than a brand name, Mylan profited at the expense of Medicaid, the government’s health-insurance program for the poor.

“Taxpayers rightly expect companies like Mylan that receive payments from taxpayer-funded programs to scrupulously follow the rules,” said William Weinreb, the acting U.S. Attorney in Massachusetts.

That’s just a little pocket change.

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