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As EpiPen Generic Announced, Senators Urge More Answers on Access

7043117657_f4e24dacd4_zSenator Chuck Grassley

Senators spearheading opposition to high U.S. drug prices expressed cautious optimism on Monday after Mylan NV said it will release a lower cost generic version of the EpiPen auto-injector within weeks. But the senators also said they need to hear more information.

“This sounds like good news but the details are important to know,” said Republican Senator Chuck Grassley from Iowa in reaction to the announcement of a generic alternative.

Mylan said that the new generic would retail for $300, about half the cost of the branded product, in a second recent move to quell public outcry over the high cost, which has risen an estimated 500 percent in the United States since 2008. Last week, Mylan  announced that commercially insured patients would be eligible for a reduction in cost of up to $300 through an EpiPen discount savings card.

Also on Monday, the House Oversight and Reform Committee requested that Mylan submit numerous documents related to the pricing of the brand-name EpiPen by Sept. 12.

In a letter he wrote last week to Heather Bresch, Mylan’s chief executive, Grassley asked the company for further information on the cause of the price spike. Following Monday’s announcement on a generic injector, he said, “I look forward to a written response as specifically requested in my letter.”

He and fellow senators Richard Blumenthal, Patrick Leahy, Ron Johnson and Amy Klobuchar, who has a daughter with food allergies, have also sent a letter to FDA commissioner Robert Califf, requesting details including: EpiPen pricing; approval processes for competitor alternatives to EpiPen; and the potential for making the drug available without a prescription.

“Given the importance of this topic, it is imperative to understand the FDA’s role with respect to EpiPens and its approval of generic equivalents that could help to increase competition and lower prices if introduced,” the senators wrote.

Earlier this year, applications for alternative auto-injectors from Teva and Adamis pharmaceutical companies were not approved by the FDA. In 2015, drugmaker Sanofi voluntarily withdrew the rival Auvi-Q injector from the market over concerns that the preloaded pens might be delivering inaccurate doses.

Blumenthal said that although Myl‎an may appear to be moving in the right direction, its announcement “raises as many questions as solutions – including why the price is still astronomically high,” adding that he will press for Senate hearings.

“The launch of a generic version of EpiPen is a step forward in addressing the dramatic price increase of the lifesaving medication,” Klobuchar said in a statement after Mylan’s generic device was announced. “I also continue my call for an FTC [Federal Trade Commission] investigation into this and other pharmaceutical pricing issues and I continue to seek answers to our questions to the FDA about its approval process and other steps for alternatives to the EpiPen.”

In response to questions from Allergic Living, the FDA said it is only able to provide information on approved drug product applications. Speaking generally of drug applications, the FDA said certain “first generics are moved to the head of the queue and given expedited review.”

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