FDA and access to medications
Anaphylaxis is a severe allergic reaction which is a medical emergency that affects the whole body and may lead to death. If someone had an anaphylaxis episode, they will always have the risk of another one. Hence, to mitigate this risk, epinephrine should be carried as an emergency treatment.
FDA understands the importance of treatment which is safe, effective and work correctly at every time. In case of anaphylaxis, EpiPen should be used with no second chance. It is an emergency epinephrine that auto-injects the dose in case of anaphylaxis episode. People usually lose access to the treatments which have the potential to save life, but becomes prohibitively expensive. In that condition, people usually look at FDA. Recently, spike in price of EpiPen has caused the concern. In addition, EpiPen products has patents listed through 2025 that could delay the generic competition.
Prices are set by the drug makers or distributors; FDA doesn't regulate the drug prices. It our job to ensure the medications, including emergency medications which are safe and effective. We also recognize that when we approve the new drugs, including generic versions of a drug, it can also improve the competition in marketplace. FDA has already improved the four epinephrine auto-injectors to treat the anaphylaxis in emergency which is a good news. However, two are currently marketed. The EpiPen does not have any FDA-rated therapeutic equivalents. FDA has approved these alternative products which are 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. FDA is also encouraging the manufacturers to develop the innovative new auto-injectors that will ensure a lifesaving drug which can be administered easily and safely by anyone. To help the development, we built a road map that will get these products on the market faster. The agency had provided the technical information for industry about designing and testing auto-injectors. In February, the FDA provided industry with the draft guidance on how to determine if patients can effectively use the new devices.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.
FDA is committing the ensure that the consumers can trust the products which are available. Although anaphylaxis is not the condition that people should avoid but surely, cost should not be the reason for someone that cannot access care.