Senators to FDA: Where are the Alternatives to Mylan’s EpiPen?

Regulatory NewsRegulatory News
| 25 August 2016 | By Zachary Brennan 

Five senators from both sides of the aisle sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday seeking more information on what the agency is doing to help authorize the use of EpiPen competitors that could bring down the cost of the autoinjector.

The letter comes amid a frenzy of Congressional outrage over the more than 400% spike in the price of Mylan’s life-saving EpiPen for those suffering from severe allergies that hasn’t been seen since the Senate investigations into Turing Pharmaceuticals and Valeant Pharmaceuticals.

Mylan on Thursday announced plans to expand the company’s “savings card” program to try to bring down the price of the $600 two-pack of EpiPens, though Sen. Richard Blumenthal (D-CT) called the move a “PR fix more than a real remedy, masking an exorbitant and callous price hike. This baby step should be followed by actual robust action.”

Sen. Charles Grassley (R-IA) also noted that Mylan’s move does not change the product’s price or what Medicare, Medicaid and insurance companies pay.

When asked if Mylan would stop hiking the prices of its drugs, Mylan CEO Heather Bresch, who’s the daughter of Sen. Joe Manchin (D-WV), told CNBC on Thursday: “We’re going to continue to run a business and continue to meet the supply and demand of what’s out there…I’m absolutely ready to work with Congress.”

Manchin said in a statement, “I am sure Mylan will have a more comprehensive and formal response” to Congressional questions.

Letter to Califf

Meanwhile, Sens. Grassley, Blumenthal, Amy Klobuchar (D-MN), Patrick Leahy (D-VT) and Ron Johnson (R-WI) are questioning why FDA has not done more to approve an EpiPen competitor.

“We are concerned that Mylan has not faced much competition for its product. One of its competitors, Auvi-Q, was recalled in October 2015 [Teva’s EpiPen generic was also rejected in March] giving Mylan a near monopoly with its product. News reports indicate that generic versions of the EpiPen have been subject to additional questioning by the FDA and have yet to be approved,” the senators wrote.

They call on FDA to clarify whether any barriers exist to the approval of safe alternatives to the EpiPen and to understand FDA's role with respect to approving generics that could help to increase competition and lower prices.

Among the questions is also one about whether FDA has looked into if the EpiPen can become an over-the-counter medication rather than requiring a prescription, and another question on how many alternatives to the EpiPen FDA is currently considering.


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