Letter to Robert Califf, MD, Commissioner, U.S. Food and Drug Administration - Urging FDA to Take Action in Response to EpiPen Prices

Letter

Dear Dr. Califf,

I write today again concerned about significant price increases for lifesaving medications and ask for your assistance in ensuring families have access to lower price alternatives. After a February 2016 letter with 29 of my colleagues, I was pleased to see the subsequent announcement that the Food and Drug Administration (FDA) would speed up the review of "sole source" drugs. However, like many Americans, I was outraged this week to see the exorbitant price increase for EpiPens by Mylan. While drug price increases have become too common, I believe this is a unique case that deserves additional attention.

As a doctor, I know that in the case of certain acute allergic reactions, individuals need epinephrine administered immediately. The most common, and virtually universal, device used to deliver epinephrine by an individual in the event of an anaphylactic reaction is the EpiPen. This device takes a century old medication and packages it in a self-administered format. This is a truly lifesaving medication. However, as a result of a more than 400% price increase, a single prescription now costs more than $600, a prohibitive price for many individuals. Because of the single use format, short shelf life, and unpredictable nature of allergic reactions, most families must purchase multiple EpiPens each year. No family should have to decide between filling a lifesaving prescription or paying their bills.

I have concerns that the underlying processes at the FDA have created conditions that have given Mylan a virtual monopoly, allowing them to drastically increase prices without consequence. Within the past year, three possible alternatives have either been rejected by the FDA or taken off the market. With appropriate competition there is increased ability to negotiate lower prices and as a result keep prices in check. I ask that you take all necessary steps to prioritize approval of alternatives to exorbitantly priced drugs, like the EpiPen, and that you work with companies that have submitted meaningful alternatives to facilitate rapid development of safe substitutes.

Additionally, I ask that you reevaluate existing guidance regarding therapeutic equivalency. Current FDA guidance prohibits families from substituting EpiPens with existing less expensive epinephrine alternatives. Uncertainty surrounding bioequivalence has contributed to provider dependence on a single pharmaceutical and discouraged insurance coverage of alternatives. What additional research is necessary to inform bioequivalence and how can Congress support the shared goal of safe innovation?

Thank you for your continued work toward an efficient approval process that encourages vigorous competition. I appreciate your immediate attention and look forward to working together to advance lower price alternatives to expensive medications.

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