5/2/2012
Do you think that the American people would benefit if epinephrine auto-injectors were changed from prescription-only to OTC or BTC without a prescription (similar to oral pseudoephedrine? As you may have heard, the FDA is currently holding an open forum on a subject that was brought forth/proposed by the American pharmacists' lobbying groups and probably from some pharmaceutical industries' lobbies, and inhaled asthma drugs, epinephrine auto-injectors, “statin” cholesterol meds, as well as blood pressure and maybe diabetes meds - are being tossed around as drugs that should be made available without a prescription, with the pharmacist's supervision, which could entail using kiosks in pharmacies, on-line questionnaires, forms, etc.

Anyway, I'm sure you are opposed to the overall gist of this proposal, and I'm sure you are horrified at the thought of diabetes meds, "statin" drugs, and albuterol (who knows, maybe ICS and combo ICS/LABAs) being available without a prescription, as am I, for many reasons.

But, specifically, what is your opinion about the epinephrine auto-injector being made available without a prescription? I was thinking about this issue long before I heard about this FDA open forum that was initiated by pharmacists. The issue of the epi auto-injector being made OTC is intriguing, and I can see pros and cons. The physician spokeswoman for the American Medical Association, Dr. Sandra Fryhofer, who is an internal medicine doctor in Atlanta, already mentioned in the AMA's official position statement that they certainly cannot endorse the entire proposition of making all those drugs ("statins, BP meds, asthma inhaled meds) available without a prescription, but she specifically said that drugs such as epinephrine may be suitable for NOT requiring a doctor's prescription, so the AMA might approve epi being released without prescription. I can see pros and cons to this idea. What are your ideas?

I am not asking you to comment on the entire variety of drugs being discussed here. I'm just asking your opinion about the epinephrine auto-injector issue (I suppose the pharmacies would have to weigh kids to see if they need the 0.15 mg or 0.3 mg dose).

Thank you for your inquiry.

I have not put a great deal of thought into this issue at the present time, but at first take, I would be against having automatic epinephrine injectors available without prescription. I have not been privy to any detailed arguments on either side of this issue, however, and would of course reserve a final opinion after the issues have been "aired out" in detail.

Thank you again for your inquiry and we hope this response is helpful to you.

Sincerely,
Phil Lieberman, M.D.