A bipartisan group of senators on Wednesday sent a letter to Food and Drug Administration Commissioner Robert Califf, MD, urging the agency to help bring more EpiPen competitors to the market.
Here are 4 things to know:
- Senators Chuck Grassley (R-Iowa), Amy Klobuchar (D-Minn.), Patrick Leahy (D-Vt.) and Ron Johnson (R- Wis.) wrote the letter that questions why the FDA has not taken more action 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, 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 letter reads.
- The senators want to know how many EpiPen alternatives the agency is currently considering and questions whether there are any existing barriers that prevent the approval of these products.
- The senators also asked whether the FDA has considered modifying EpiPens into an over-the-counter product.
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