Mylan CEO Regrets Patient Blowback, But Not Expanded EpiPen Use


Heather Bresch

Photographer: Michael Nagle/Bloomberg
  • CEO Heather Bresch to testify before House committee Wednesday
  • Congress has raised concern over price hikes of EpiPen

Mylan NV’s chief executive officer will tell Congress Wednesday that although she regrets some patients’ financial difficulties affording the EpiPen allergy shot, lawmakers should still recognize that the company has increased access to the drug.

CEO Heather Bresch will testify before the U.S. House Committee on Oversight and Government Reform and face questions from lawmakers about how the company raised the cost to about $600 for a two-pack, from $57 a shot when Mylan acquired the rights to sell the product in 2007.

“Looking back, I wish we had better anticipated the magnitude and acceleration of the rising financial issues for a growing minority of patients” who had to pay the full list price or more, Bresch said in the prepared testimony. “We never intended this.”

Bresch pointed to what she says is a misconception about EpiPen’s actual prices, and to the measures the drugmaker took shortly after the controversy erupted several weeks ago to help lower costs, including a generic version for $300. The pricing of a drug is “opaque and frustrating,” she said, especially for patients.

While the list price -- or WAC, wholesale acquisition cost -- of the two-EpiPen pack is $608, Mylan takes home about $100 after rebates and fees, as well as other costs, Bresch said.

Mylan helped push policies that had schools stock the drug, which is now the dominant epinephrine auto-injector in the U.S. The company, which has a legal address in the Netherlands but is run from Canonsburg, Pennsylvania, has led campaigns to get parents and children to carry the shots and raise awareness of dangerous allergic reactions that EpiPen is used to treat.

“Price and access exist in a balance, and we believe we have struck that balance,” Bresch said in her testimony.

Mylan has reached more than 80 percent of patients who need an EpiPen compared to fewer than 1 million of the 43 million people at risk who had access in 2007, Bresch said. About 85 percent of patients pay less than $100 for a two-pen pack, she said. The company also provided 700,000 free Epipens to schools nationwide.

The panel will also hear from Douglas Throckmorton, a deputy director at the Food and Drug Administration’s Center for Drug Evaluation and Research, or CDER. Lawmakers have questioned the agency about delays in approving a competing generic to Mylan’s shot.

The FDA is helping closely held drugmakers Kaleo Inc. and Amedra Pharmaceuticals bring back EpiPen competitors that had been taken off the market, Throckmorton said. He didn’t mention Teva Pharmaceutical Industries Ltd.’s generic EpiPen, which the FDA rejected. Teva said the FDA cited “major deficiencies” in its application and any generic would likely be delayed until 2017.

The House hearing Wednesday isn’t the only hot water Mylan is in. West Virginia State Attorney General Patrick Morrisey, a Republican, said Tuesday he was launching an investigation into possible Medicaid fraud by the drugmaker. Bresch is the daughter of Senator Joe Manchin, a Democrat from West Virginia.

The investigation was the latest of a mounting number of probes by lawmakers and law enforcement. State attorneys general in Minnesota and New York also have inquiries, as do several congressional committees.

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