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Mylan Plans generic EpiPen to quell outcry over $600 cost

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(Bloomberg) — Mylan NV will sell a generic version of its EpiPen at half the price of the branded $600 emergency allergy shots in coming weeks, bowing to pressure after U.S. lawmakers derided earlier steps last week as a mere public-relations fix.

The drugmaker, whose offer of assistance programs to help patients cover out-of-pocket expenses was blasted as insufficient, will introduce a generic EpiPen identical to the branded product, which includes the drug itself and the handheld pen with a needle that injects the shot. The company also plans to continue to sell the branded version, according to a statement on Monday.

Mylan has attracted scrutiny for increasing the treatment’s price 400 percent in nine years — EpiPen cost $57 for a single pen when the drugmaker bought it in 2007. Criticism of Chief Executive Officer Heather Bresch, the daughter of Democratic Sen. Joe Manchin of West Virginia, quickly intensified last week as members of the Congress called for investigations and the EpiPen became campaign fodder. Introducing a so-called authorized generic, which doesn’t require formal approval from the Food and Drug Administration, is a fast way for Mylan to get a cheaper version out — without actually cutting the branded EpiPen’s price.

Related: Mylan to reduce EpiPen patient out-of-pocket costs as political pressure mounts

“They can just do it. They don’t need approval,” said David Rosen, a lawyer at Foley and Lardner LLP. The move won’t block future generics from competitors such as Teva Pharmaceutical Industries Ltd., but it can help Mylan capture some of the market share it would have lost with the introduction of a rival generic, he said.

Mylan shares were little changed at $43.04 at 10:03 a.m. in New York. The stock had declined 12 percent last week as criticism mounted.

‘Deep frustration’

“Ensuring access to medicine is absolutely the core of Mylan’s mission,” CEO Bresch said in the statement. “We understand the deep frustration and concerns associated with the cost of EpiPen to the patient, and have always shared the public’s desire to ensure that this important product be accessible to anyone who needs it.”

Mylan’s control of the market increased in the past year as competitors suffered setbacks. In March, the Food and Drug Administration identified “ major deficiencies” in Teva’s application for a generic version. In October, Sanofi voluntarily recalled its Auvi-Q injector from the market over concerns about suspected malfunctions in the U.S. and Canada.

The EpiPen price increases drew particular attention in Washington because Bresch had successfully pushed legislation to encourage use of the EpiPen in schools nationwide. Mylan spent about $4 million in 2012 and 2013 on lobbying for access to EpiPens generally and for legislation, including the 2013 School Access to Emergency Epinephrine Act, according to lobbying disclosure forms filed with the Office of the Clerk for the House of Representatives.

The measures announced last week, including expanded coverage assistance and a $300 savings card, will remain in place for the branded product, Mylan said in its statement.

Democratic presidential nominee Hillary Clinton, who called the price increases outrageous last Wednesday, said last week that offering discounts with cutting the overall price was insufficient.


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