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Senators question price increase of EpiPens from $57 to $500

By Allen Cone

WASHINGTON, Aug. 23 (UPI) -- Massive price increases on the drugs used in EpiPens have drawn outrage from four U.S. senators.

The pens, manufactured by Mylan, are used in an emergencies for food allergies and there are no generic equivalents. The pens were created in the mid-1970s but Mylan acquired the pens and other drugs from Merck in 2007.

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Sen. Chuck Grassley, R-Iowa, wrote the manufacturer, Mylan, asking why the epinephine auto-injector has risen from $57 in 2007 to about $500 today.

Sen. Amy Klobuchar, D-Minn., has asked the Federal Trade Commission and the Senate Judiciary Committee to investigate.

Sen. Richard Blumenthal, D-Conn., wrote the company for data about price assistance programs and demanded that Mylan lower its price.

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Sen. Bernie Sanders told NBC News last week in a statement that "the only explanation for Mylan raising the price by six times since 2009 is that the company values profits more than the lives of millions of Americans."

"I am concerned that the substantial price increase could limit access to a much-needed medication," Grassley wrote in the letter to Mylan CEO Heather Bresch.

Public schools and other government institutions buy the pens, Grassley noted.

"Many of the children who are prescribed EpiPens are covered by Medicaid and therefore the taxpayers are picking up the tab for this medication," Grassley wrote.

Klobuchar noted her own daughter uses the pens.

"Many Americans, including my own daughter, rely on this life-saving product to treat severe allergic reactions," Klobuchar said in letter. "Although the antitrust laws do not prohibit price gouging, regardless of how unseemly it may be, they do prohibit the use of unreasonable restraints of trade to facilitate or protect a price increase."

Up to 6 percent of children have food allergies, according to the federal Centers for Disease Control and Prevention.

She said the increase in price from $57 to $500 over the last nine years puts "life-saving treatment out of reach to the consumers who need it most."

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"There does not appear to be any justification for the continual price increases of EpiPen," Klobuchar wrote FTC chairwoman Edith Ramirez. "Manufacturing costs for the product have been stable and Mylan does not need to recover the product's research and development costs because the product was on the market years before Mylan acquired it in 2007.

EpiPens don't have much competition. Auvi-Q, sold by Sanofi, was taken off the market in October 2015 because some devices weren't dispensing the proper amount of medication. Teva Pharmaceutical Industries applied for a generic EpiPen, but the application was rejected by the FDA earlier this year. Another auto-injector, the Adrenaclick, is prescribed far less frequently and some insurers don't cover the cost.

Mylan, in a statement, did not specifically defend the price increases but only mentioned people are paying more out of pocket for the pens because of higher deductible insurance plans.

"This current and ongoing shift has presented new challenges for consumers, and now they are bearing more of the cost," the company said in a statement released Tuesday. "This new change to the industry is not an easy challenge to address, but we recognize the need and are committed to working with customers and payors to find solutions to meet the needs of the patients and families we serve."

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It noted that with a Mylan's My EpiPen Savings Card those eligible can receive up to three EpiPen 2-Paks or EpiPen Jr 2-Pak cartons per prescription at no cost. And Mylan said it offers a patient assistance program for qualifying patients.

Many emergency medical responders and families are turning to manual syringes as a cheaper alternative.

"Anyone using this approach would require extensive medical training to do it effectively and safely, without contamination or accidental intravenous injection," Dr. James Baker, Jr., the CEO and chief medical officer of Food Allergy Research & Education, told STAT.

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