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Mylan CEO to testify in hearing on EpiPen price increases

| Wednesday, Sept. 14, 2016, 1:03 p.m.
Heather Bresch, chief operating officer of Mylan Pharmacueticals, sits in her office in Canonsburg on April 8, 2008. Bresch will face lawmakers' questions at a hearing next week on steep price hikes for the company's life-saving EpiPen injector device.
Heather Bresch, chief operating officer of Mylan Pharmacueticals, sits in her office in Canonsburg on April 8, 2008. Bresch will face lawmakers' questions at a hearing next week on steep price hikes for the company's life-saving EpiPen injector device.
Heather Bresch, CEO of Mylan
Heidi Murrin | Trib Total Media
Heather Bresch, CEO of Mylan

Mylan CEO Heather Bresch will appear at a congressional hearing next week to face questions about steep price increases for the lifesaving EpiPen device as the drugmaker begins to turn over requested financial documents, a House committee said Wednesday.

The Oversight and Government Reform Committee is the first of several congressional panels probing the issue to say that Bresch would appear at a hearing. Several committees have sent requests for information to Netherlands-based Mylan, which is run from offices in Cecil, concerning the drug's 500 percent price increase since the company bought the rights to the device in 2007, to $608 for a two-pack.

“There is justified outrage from families and schools across the country struggling to afford the high cost of EpiPens,” said Oversight and Government Reform Committee leaders Jason Chaffetz, R-Utah, and Elijah Cummings, D-Md., in a statement announcing Wednesday's hearing.

A spokeswoman for Mylan could not be reached.

The committee announcement said Mylan “indicated that it will begin producing documents this week” in connection with a letter that Chaffetz and Cummings sent to Bresch last month. The letter sought documents and communications regarding Mylan's revenue from EpiPens since 2007, manufacturing costs and how much the company receives from federal health care programs.

In addition to Bresch, the committee lists as a witness at the hearing Doug Throckmorton, deputy director of the Center for Drug Evaluation and research at the Food and Drug Administration. Lawmakers have been critical of the FDA over delays in approving a generic competitor to the EpiPen.

The EpiPen auto injector enjoys a near monopoly in the market.

Prefilled with a small dose of epinephrine, it is used to stop potentially fatal allergic reactions to insect bites and foods such as nuts. Many schools require students with allergies to have them on hand.

Politicians, including Democratic presidential nominee Hillary Clinton, and consumer advocates have accused Mylan of price gouging in a furor that has grown since last month.

The Senate Aging Committee asked Mylan for information and the Senate Permanent Subcommittee on Investigations has taken the first step toward a formal investigation.

Bresch is the daughter of Democratic Sen. Joe Manchin of West Virginia.

In a response last week to questions from Iowa Sen. Chuck Grassley, the Republican chair of the Judiciary Committee, Mylan explained it increased the price to cover the costs of research, advocacy and improvements it made to the product.

The company launched a new version of the EpiPen in 2009 that made it easier to carry, hold and administer the injection, Mylan said.

It also was investing in improving the drug formulation to have a longer shelf life so that consumers would not have to replace unused injectors as frequently.

Grassley called Mylan's seven-page letter “an incomplete response” and said he would keep pressing for answers while working to bring generic competitors to the market.

Chaffetz and Cummings said their committee would look at ways to encourage competition and speed FDA approval of generic alternatives.

“Our goal is to work together to ensure that critical medications, like the EpiPen, are accessible and affordable for all of our constituents,” they wrote.

David Conti is the assistant business editor at the Tribune-Review. Reach him at 412-388-5802 or dconti@tribweb.com.

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