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WSJ: Mylan CEO Faces Tough Questioning in Congressional EpiPen Hearing

Mylan MYL 2.58 % NV Chief Executive Heather Bresch faced tough questioning Wednesday from Republicans and Democrats in Congress probing price increases for the EpiPen allergy treatment. Read more.
By: Jonathan D. Rockoff, Louise Radnofsky and Daniela Hernandez

Mylan MYL 2.58 % NV Chief Executive Heather Bresch faced tough questioning Wednesday from Republicans and Democrats in Congress probing price increases for the EpiPen allergy treatment.

Ms. Bresch told a House committee that the company profited far less than the nearly $609 list price for a pack of two might suggest, making $100 a pack after rebates and other costs. She said Mylan was trying to address public concerns by preparing to sell a half-priced generic version.

“We believe it was a fair price, and we now just lowered it by half,” Ms. Bresch said.

Her remarks triggered criticism from Oversight and Government Reform Committee members from both parties. Several accused Mylan during the first hours of the hearing of profiting excessively from a relatively inexpensive drug that patients’ lives depend on.

“I am a very conservative and pro-business Republican, but I am sickened by what I’ve heard,” Rep. John Duncan (R., Tenn.) said.

Rep. Gerald Connolly (D., Va.) said if he relied solely on Ms. Bresch’s testimony he would think “what humanitarians” those at Mylan are. “You virtually have a monopoly, and used it to your advantage; but unfortunately, it is at the expense of people who need it,” Rep. Connolly said.

The hearing adjourned after about 2½ hours, with plans to reconvene later in the evening.

The Food and Drug Administration also faced criticism. Several Republicans chastened the agency for failing to speedily approve epinephrine injectors developed by other companies that could bring competition to the market.

Douglas Throckmorton, an official in the FDA’s drug division, said the FDA had approved four products. He didn’t elaborate.

Last year, Sanofi SASNY 1.03 % recalled its Auvi-Q epinephrine injectors, which had been a rival to EpiPen, due to dosing problems. The “FDA cannot approve a product for which we have not received an application,” Dr. Throckmorton also said.

Despite the committee’s repeated questions, Dr. Throckmorton declined to say if the agency was reviewing any other applications and if so, how many.

In February, Teva Pharmaceutical Industries Ltd. TEVA 1.11 % said the FDA had rejected the company’s application for a generic version of Mylan’s product.

Mylan had challenged Teva’s application, arguing that differences between the two products endangered patients.

Although committee members repeatedly criticized high drug prices, there was little discussion of any potential solutions.

People with severe allergies, including many children, carry EpiPens in the event they suffer a severe allergic reaction requiring emergency treatment.

After acquiring the injectors in late 2007, Mylan has raised the price 17 times by a total of 548%.

The price increases triggered an outcry in late August, as many parents of children with allergies were buying new packs of the EpiPens.

Ms. Bresch said Mylan has given away tens of thousands of EpiPens to schools and patients, and the company didn’t anticipate such an outcry.

“You never anticipated [an outcry]?” Rep. Jason Chaffetz (R., Utah), the chairman of the House Oversight and Government Reform Committee, asked. “You raised the price, what did you think was going to happen?”

In answering committee questions ahead of the hearing, Mylan said it had $912 million in net revenue from EpiPens last year and spent $97 million on marketing, according to Rep. Elijah Cummings (D., Md.). Mylan, which mostly sells generic drugs, doesn’t break out EpiPen gross sales.

During the second half of the hearing, legislators continued to push Mylan’s CEO to explain her company’s pricing strategy. Ms. Bresch repeatedly responded that Mylan had done its best to make the medication available to patients.

Before closing, the committee again asked Ms. Bresch to turn over documents, including company contracts with manufacturers, suppliers, distributors, PBMs and other partners, and criticized her for not being transparent.

“They’re just begging us to look deeper,” Mr. Chaffetz told reporters after the hearing was adjourned.

http://www.wsj.com/articles/mylan-ceo-to-shift-blame-on-epipen-pricing-at-house-hearing-1474466910

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