health agency tells Grassley there is no EpiPen deal yet
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[January 20, 2017]
NEW YORK (Reuters) - Mylan NV has
yet to reach a settlement with the U.S. Department of Justice over the
classification in the Medicaid program of its life-saving EpiPen allergy
treatment, according to a letter from a regulatory agency disclosed on
Mylan said in October that it would pay $465 million to resolve
allegations it underpaid U.S. government healthcare programs. The
company told Reuters in November it was working to finalize that
However, there is no agreement so far, according to the letter to
Senator Charles Grassley from the outgoing head of the Centers for
Medicare & Medicaid Services (CMS), Andrew Slavitt. The letter was
made public by Grassley.
"It remains the case that there is no settlement with any potential
party," the letter read. Slavitt's CMS tenure is due to end on
Friday with the start of a new presidential administration.
Mylan declined to comment on the letter. The Justice Department also
declined to comment.
The dispute involves the classification of EpiPen as a generic
rather than branded product, which led to much smaller rebates from
the company to state Medicaid programs. CMS has argued that EpiPen
meets the definition of a branded drug.
Mylan was criticized by consumers and lawmakers after it hiked the
price of its auto-injector, used to address severe allergic
reactions, six-fold in less than a decade to $600 per pair. Last
month, it began offering its own generic version of the EpiPen at
half that price.
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Grassley has been pressing for more information on any settlement
between Mylan and the Justice Department. In November, the senator
said Mylan had declined to testify at a Judiciary Committee hearing
on a potential deal.
(Reporting by Caroline Humer and Bill Berkrot in New York; Editing
by Alan Crosby and Daniel Wallis)
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