FDA adds voice to EpiPen saga

Recent news about the price spike of EpiPen, manufactured by Mylan NL, has caused heightened concern among lawmakers and the general public. In a letter to Mylan in late August 2016, Sen. Chuck Grassley (R-Iowa) asked a series of questions about the pricing, including what analyses were conducted in determining the price, Mylan’s advertising budget for EpiPen in the first half of 2016 as well as 2015, an explanation of the features the company said have improved the product and its value, whether the company offers patient assistance programs, and whether the company has school assistance programs for providing the drug and if so, how many schools have used the programs. In addition, on September 21, 2016, the House Committee on Oversight and Government Reform will hold a bipartisan hearing with officials from Mylan to ask CEO Heather Bresch about the price spikes.

Mylan, which acquired the product in 2007, recently raised the list price for a pair of EpiPen auto-injectors to $600. The price has been rising from a cost of about $100 in 2008. In addition, the EpiPen product has patents listed through 2025 that could delay generic competition.

In the FDA Voice, the agency’s official blog, Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, noted that the EpiPen product has patents listed through 2025 that could delay generic competition. As a result, questions are raised as to what role the FDA can take in the EpiPen saga. Woodcock went on to stress that while the FDA does not regulate drug prices – it can ensure that safe and effective generic versions of a drug can be approved for the market. The FDA has already approved four epinephrine auto-injectors to treat anaphylaxis in an emergency, with two currently marketed. The EpiPen notoriety is because it does not have any FDA-rated therapeutic equivalents at the time.

The FDA does not regulate drug prices – prices are set by the drug makers or distributors. It’s our job to ensure medications, including emergency medications, are safe and effective. We also recognize when we approve new drugs, including generic versions of a drug, it may improve competition in the marketplace. The good news is that the FDA has already approved four epinephrine auto-injectors to treat anaphylaxis in an emergency, and two are currently marketed. The EpiPen does not have any FDA-rated therapeutic equivalents. But like EpiPen, these alternative products are approved by the FDA as safe and effective for treating anaphylaxis. As always, patients should check with their doctor on whether a particular treatment is appropriate and available.

According to Woodcock, the FDA is doing all it can to encourage manufacturers to develop new auto-injectors for epinephrine that can be administered easily and safely by anyone. She highlighted the “roadmap” issued by the FDA via a draft guidance in June 2013 to help manufacturers get the auto-injectors to market faster. Earlier this year, the FDA provided industry with a draft guidance on how to determine if patients can effectively use the new devices.

Not only did the FDA take actions to encourage auto-injector development, the agency touted that it speeds along the process by prioritizing and expediting reviews of applications for first generics.