Mylan CEO in 2006 Slammed Practice It’s Now Using on EpiPen

Mylan CEO in 2006 Slammed Practice It’s Now Using on EpiPen August 30, 2016
By Alex Keown, BioSpace.com Breaking News Staff

PITTSBURGH – Heather Bresch, chief executive officer of Mylan NV , is tasting a little bit of the proverbial crow, after words said 10 years ago are coming back to haunt her.

In 2006, Bresch condemned the use of “authorized generics,” precisely the kind of drug her company is now providing following the uproar of pricing for the life-saving medicine used in its EpiPen Auto-Injector. On Monday, Mylan announced it will launch the first generic to EpiPen at a price of $300 for a two-pack of the drug. The move was a response to public outcry over the nearly $600 price for the injector device. Mylan said it expects to launch the product in several weeks, pending completion of labeling revisions.

But, it was only 10 years ago when Bresch addressed Congress decrying the practice of drug companies selling unbranded versions of their own drugs. At the time, Bresch said the practice stifled generic competition, Bloomberg reported this morning. She called it “the single greatest threat to the generic industry going forward,” Bloomberg said. However, Bloomberg notes that Bresch was specifically talking about the use of authorized generics during the 180-day window the U.S. Food and Drug Administration gives to first generic drug makers. She told Congress in 2006 that the 160-day window reduced incentives for generic drug makers to get their products approved, Blomberg reported.

“For brand companies, authorized generics are a long-term strategy designed to debilitate our industry,” Bresch said in 2006, according to Bloomberg. “There is no short-term benefit and there is long-term detriment to the generic industry because of this practice.”

A spokesperson for Mylan told Bloomberg that the industry has dramatically changed since 2006 and the use of authorized generic drugs is now a standard practice. In fact, the company has shown that it embraced the authorized generic route on a couple of occasions. Bloomberg noted that in 2013, Mylan reached a settlement with Orion Corp. to sell the authorized version of that company’s Parkinson’s disease treatment Stalevo. In 2014, Mylan was successful in a lawsuit to halt an authorized generic of GlaxoSmithKline Plc ’s antidepressant Paxil CR. Mylan said it was in violation of a patent settlement, Bloomberg reported.

Since company acquisition of the EpiPen in 2007, the price has dramatically increased from $57 to nearly $500, a 400 percent increase. The EpiPen generated more than $1.2 billion in revenue for 2015, accounting for about 40 percent of Mylan’s overall earnings. The revenue stream has not only been good for the company’s bottom line, but also served as a catalyst for big payday raises for its top executives, including Chief Executive Officer Heather Bresch.

Since 2007, the year Mylan acquired the EpiPen, her salary has skyrocketed from $2.4 million to $18.9 million as of last year. When that information came to light, so too did stories of people choosing to forego paying for the emergency-use EpiPen due to the high cost, as well as public outrage simply over the price of the auto-injector—a common theme this election cycle that started last year with Turing Pharmaceutical’s 5,000 percent overnight price hike of the toxoplasmosis drug, Daraprim. In fact several members of the U.S. Senate, as well as Hillary Clinton, called for the company to reduce the price of the EpiPen. Bresch is the daughter of U.S. Sen. Joe Manchin, a Democrat from West Virginia.

Since the outcry though, Mylan announced plans to increase customer access to the EpiPen by expanding company programs to offset the high cost of the precise-dose auto-injectors, as well as its free EpiPen program for schools across the United States. Mylan also said it is doubling eligibility for its patient assistance program to 400% of the federal poverty level. This means a family of four making up to $97,200 would pay nothing out of pocket for their EpiPen. Lastly, the company said it is opening a pathway for people to order the pen directly from the company as part of an effort that will reduce costs.

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