The following is a statement from Dr Janet Woodcock providing the US Food and Drug Administration’s response to the high cost of the EpiPen epinephrine auto-injector currently being investigated by congress.
Dr Woodcock is the FDA’s Director of the Center for Drug Evaluation and Research and her statement appears on the FDA’s blog FDA Voice.
A severe allergic reaction called anaphylaxis is a medical emergency that affects the whole body and, in some cases, leads to death. If you have had an anaphylaxis episode, you always face the risk of another one. To mitigate the risk you or your caregiver should carry an emergency treatment called epinephrine at all times, because every second counts.
At the FDA, we understand how important it is for this treatment to be safe, effective, and work correctly every time. And in the case of a very severe reaction such as anaphylaxis, when there may be no second chance, the device that delivers the medication is just as critical. EpiPen, a popular form of emergency epinephrine that auto-injects the dose, is one of these treatments.
But sometimes, when medications become prohibitively expensive, some people lose access to a potentially life-saving treatment. When that happens, people often look to the FDA. Recent news about the price spike of EpiPen has caused concern. In addition, the EpiPen product has patents listed through 2025 that could delay generic competition. And so we are asked, what role does the FDA play?
The FDA doesn’t 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.
We stand ready to quickly review additional applications that come to us from manufacturers, especially applications for generic versions. To speed along the process, our Office of Generic Drugs prioritizes and expedites our review of applications for first generics, making sure that the first applicants to make a generic are moved to the head of the queue and given priority review.
We at the FDA are also doing all we can to encourage manufacturers to develop innovative new auto-injectors that ensure a life-saving drug can be administered easily and safely by anyone. To help development, we built a roadmap that will get these products on the market faster. In June 2013, the agency provided technical information for industry about designing and testing auto-injectors. In February, the FDA provided industry with draft guidance on how to determine if patients can effectively use the new devices. We do not want substandard quality products to come to market, because a patient suffering a life-or-death event has to be able to pick up and use a device without a moment’s hesitation.
The FDA is committed to ensuring that consumers can trust the products that are available. Anaphylaxis is a condition some people can’t avoid, but cost should not be the reason someone cannot access care.
Note that of the four auto-injectors mentioned in the statement that were approved for sale in the US, two are no longer sold: The Auvi-Q was recalled from the market by Sanofi in 2015 and Impax, marketer of both the Amedra Twinject and the generic version of the same sold by its Lineage subsidiary, now only sells the generic version.