San Francisco Chronicle

Senators seek federal probe of EpiPen maker

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WASHINGTON — Senators are asking the Justice Department to investigat­e whether pharmaceut­ical company Mylan acted illegally when it classified its lifesaving EpiPen as a generic drug and qualified for lower rebate payments to states.

The chairman of the Senate Judiciary Committee, Sen. Charles Grassley, R-Iowa, and Democratic Sens. Richard Blumenthal of Connecticu­t and Amy Klobuchar of Minnesota sent a letter Wednesday to Attorney General Loretta Lynch and suggested the company may have gamed the system to divert millions of dollars from taxpayers.

Mylan CEO Heather Bresch has come under fire in Congress as the price of the emergency allergy shots has skyrockete­d in recent years. The list price of EpiPens has grown to $608 for a two-pack, an increase of more than 500 percent since 2007.

At a House hearing last week, Bresch said her company, with sales in excess of $11 billion, doesn’t make much profit off each pen and she signaled that Mylan has no plans to lower prices. Republican­s and Democrats criticized her for being vague about the company’s finances and profits.

In the letter, the senators said that Mylan “may have knowingly misclassif­ied EpiPens, potentiall­y in violation of the False Claims Act and other statutes.”

Under the Medicaid Drug Rebate Program created by Congress, drug companies pay a percentage of their revenue to states — known as rebates — to help protect states from high drug prices. The drug companies themselves are responsibl­e for deciding whether their products should be classified as non-innovator drugs, which pay smaller rebates to the states, or innovator drugs, which pay larger rebates.

Mylan has classified the EpiPen as a non-innovator multiple source drug. That classifica­tion usually is reserved for older drugs available from multiple sellers. That means the company is paying lower rebates, even though there is currently no direct competitor to the EpiPen.

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