Press Release

Sacramento – Today, Congressman Ami Bera, M.D. (CA-7) called on the Food and Drug Administration (FDA) to take immediate action to make lower cost alternatives available in response to exorbitantly priced EpiPens from the drug manufacturer Mylan. Currently, EpiPens have a virtual monopoly on the market for emergency allergy attack treatment. In the letter, Congressman Bera asks the FDA to address processes that may limit competition and allow some companies to drastically increase prices. Today, Mylan announced they would offer additional coupons for EpiPens, but have not addressed the underlying cost.

“As a doctor, I know that in the case of an allergic reaction no time can be wasted and we can’t allow anything to stand in the way of immediate access to epinephrine.” said Bera. “$600 for an EpiPen is outrageous, and Mylan must be held accountable for their pricing on a life-saving drug. That’s why I’m calling on the FDA to make sure that families have other more affordable and safe options to EpiPens so that no one needs to make a choice between paying their bills or having a life-saving drug.”

Congressman Bera has previously urged the FDA to regulate the prices of life-saving drugs. He lead the push to ensure that drug companies are not able to charge excessive prices for drugs, like in the case of Martin Shkreli and Turing Pharmaceuticals.

The text of the letter is below:

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

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.

Sincerely,

Ami Bera, M.D.
Member of Congress