FARE Medical Advisors’ Letter to FDA on Epinephrine

Scott Gottlieb, MD
Commissioner of Food and Drugs
U.S. Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Email: CommissionerFDA@fda.hhs.gov

Dear Dr. Gottlieb:

The shortage affecting two of the three epinephrine auto-injectors (EAIs) on the market in the U.S. has been in effect since May and has continued to be a source of deep concern and frustration for patients at risk for anaphylaxis who depend on this lifesaving medication.

As medical advisors to Food Allergy Research & Education (FARE), the nation’s leading advocacy nonprofit dedicated to food allergy, we are writing to urge the FDA to use all available legal remedies to ensure that all patients at risk for anaphylaxis across the country have access to epinephrine auto-injectors that have been prescribed to them. The national shortage, which has continued into Back-to-School season, has major implications for parents who are trying to fill multiple prescriptions to ensure that their children have EAIs both at home and at school.

Specifically, we feel it is of critical importance for the FDA to provide guidance on using expired epinephrine auto-injectors and to permit importation of approved EAIs from other developed countries. Taking action on these two matters will alleviate the problem and address concerns from parents and schools who currently may only have access to expired EAIs.

Expired Epinephrine

We have recommended to members of the food allergy community that in the absence of a current epinephrine auto-injector, patients may use an expired dose but should call 911 and receive follow-up medical treatment. (We note that if patients have a device that has a viewing window and the solution appears cloudy or discolored, they should not use it.)

We request that the FDA issue official guidance concerning the safety of using epinephrine auto-injectors beyond printed expiration dates, similar to what FDA has already done for the epinephrine injection Abboject syringe in extending expiration dates for nine months: www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm563360.htm.

This is important because the public – and schools in particular – must be informed that expired epinephrine can be kept on hand for emergencies, especially during a time when current devices may be difficult to obtain. We ask that the FDA clearly communicate to schools that expired doses from undesignated epinephrine stock should not be discarded until they are replaced with new ones. Research has shown that epinephrine may retain its potency beyond its expiration date. (See citations at conclusion of letter.)

Options Overseas

We also renew our request that the FDA approve the importation of other EAIs approved by the European Union into the U.S., which would address supply issues and price competition.

Nearly 6 million children have at least one food allergy, and almost 40 percent of these kids have experienced a severe allergic reaction such as anaphylaxis. No one should be without this lifesaving drug due to lack of access or affordability.

We look forward to the FDA’s actions on this critically important matter.

Sincerely,

James R. Baker, Jr., MD
Chief Medical Officer, FARE

FARE Clinical Advisory Board Executive Committee:

J. Andrew Bird, MD, UT Southwestern Medical Center; Children’s Medical Center Dallas
Christina Ciaccio, MD, MSc, The University of Chicago
Lynda Schneider, MD, Harvard Medical School; Boston Children’s Hospital
Jonathan Spergel, MD, University of Pennsylvania School of Medicine; Children’s Hospital of Philadelphia
Stephen Tilles, MD, Northwest Asthma and Allergy Center

Studies on Effectiveness of Epinephrine Past Expiration Date:

Cantrell FL, Cantrell P, Wen A, Gerona R. Epinephrine concentrations in EpiPens after the expiration date. Ann Intern Med. 2017; 166(12):918-919.

Rachid O, Simons FE, Wein MB, Rawas-Qalaji M, Simons KJ. Epinephrine doses contained in outdated epinephrine auto-injectors collected in a Florida allergy practice. Ann Allergy Asthma Immunol. 2015; 114(4):354-356.e1.