Letter to Dr. Robert M. Califf, Commissioner, Food and Drug Administration - Regarding the Drastic Price Increase for EpiPens

Letter

Dr. Robert M. Califf
Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Califf,

We are writing today out of concern over the rapidly increasing cost of basic pharmaceuticals, specifically EpiPen (epinephrine injection) Auto-Injector, which is used in emergency treatment for anaphylaxis. We are concerned that recent steep increases in price may put this common medication out of reach for people who desperately need it.

According to various news reports, Mylan purchased EpiPen in 2007. The EpiPen has been in used since 1977 and when Mylan bought it in 2007, it cost $57 each. Today, the cost of two EpiPens has risen to a reported $608 for an increase of more than 500 percent. In France, two EpiPens cost approximately $85 and in the United Kingdom two cost $119. Notably, in Canada, a Mylan brand EpiPen costs $131. In addition to the EpiPen, alternatives such as Anapen are available in France, Canada and the United Kingdom with prices comparable to the EpiPen.

We have heard from many concerned New Mexicans, including one of whom used to pay $16 for her yearly prescribed EpiPen and now with the same private insurance she is paying more than $100. We are concerned that these drastic price increases will force some New Mexico families to make choices between affording a child's EpiPen or other household expenses. Many New Mexicans don't have the flexibility in their income to allow for such a dramatic increase in this low-production cost medication.

We request that the FDA utilize all available resources to build a robust pipeline of alternatives and carefully expedite the approval process of EpiPen alternatives and biosimilars. We look forward to hearing back from you about possible solutions to this issue and hearing more about steps you are taking to ensure that competitive options are carefully considered and approved for EpiPens and other needlessly high cost pharmaceuticals.