Davis Sends Letter to FDA After EpiPen Price Increase
U.S. Rep. Rodney Davis (R-Ill.) today announced that he sent a letter, along with several other members of Congress, to the Food and Drug Administration (FDA) after EpiPen prices increased more than 400 percent since 2004. The letter expresses concern about the dramatic cost increase for the EpiPen and encourages the FDA to spur competition by streamlining the approval process so consumers have generic options available to them.
Congress is continuing to investigate the price increase. The House Committee on Oversight and Government Reform will hold a hearing with officials from Mylan Pharmaceutical and the FDA this week.
“We need to not only investigate why Mylan upped the cost but also why there is not an alternative on the market,” said Davis. “It’s unacceptable that only one company is able to sell a life-saving drug like the EpiPen for so long. It seems the FDA’s convoluted approval process for generic drugs has led to a massive backlog of more than 4,000 applications. We’re asking the FDA and also Mylan Pharmaceutical for answers because millions of Americans, many of them children, rely on this life-saving medication to treat severe allergic reactions.”
Text of the letter sent to the FDA is below.
Robert M. Califf, M.D.
United States Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Dear Commissioner Califf,
We are writing to express our serious concerns regarding the current monopoly held by Mylan Pharmaceuticals on the EpiPen (epinephrine injection) Auto-Injector, which is used in emergency treatment for life-threatening allergic reactions. We have heard from many families who share our concern regarding the decreased access to this life-saving drug.
It is our understanding that the reason access to this drug has become an issue is due to its skyrocketing costs. The price for a two-pack has increased from an average of about $50 in 2004 to more than $300 each today. These price increases have created a significant cost burden on those who rely on them for anaphylactic emergencies. The skyrocketing costs of EpiPens is a direct result of the absence of competition and an inefficient Food and Drug Administration (FDA) review process.
The shortage of competition has allowed Mylan to continue to increase prices for EpiPen, knowing that there is no generic version currently on the market. It is disappointing that the FDA recently rejected a request by a pharmaceutical company to start producing an alternative. This only makes affordable access more difficult for the 3.6 million Americans who rely on this device.
The FDA should seek to spur competition by streamlining the approval process in a way that reduces barriers to entry for pharmaceutical companies wishing to produce epinephrine auto injectors while ensuring all new products are safe for use. It would be helpful to know if the FDA could clarify whether any barriers exist to the approval of safe alternative products to EpiPen. We would also like to know how many alternatives to Mylan’s EpiPen are currently being reviewed by the FDA and where they are in the review process.
Thank you in advance for your consideration.