U.S. health agency tells Grassley there is no EpiPen deal yet

EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016. REUTERS/Jim Bourg/File Photo

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 Thursday.

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 deal.

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.

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