> What seems to be missing is a more sophisticated understanding of risk and a legal framework that substitutes the risk assessment of individual patients (or parents) for a one-size-fits-all decision by a bureaucracy.
I guess I disagree that this understanding is lacking, in fact, I find that medical professionals (including those in regulatory bodies, of which there are many) have an excellent understanding of risk/benefits.
> We are hearing stories now of people going with fewer EpiPen's because of the cost. Is that a better situation than Auvi-Q's sometimes in-accurate dose? I don't know but it is a question that comes to mind.
It is unacceptable to market a device that does not work as designed, especially when the malfunction is unpredictable or results in uncertainty that makes treatment more complicated. Why should Auvi-Q be different?
> The government apparently requires purchase of two EpiPens to reduce the risk in case a single dosage is insufficient, but this doubles the cost.
The government makes no such requirement. NIAID guidelines (http://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Document...) recommend that a physician prescribe for two auto-injector doses as a part of first-line treatment. Two doses makes sense, especially with a device like this: as the saying goes, two is one and one is none. A package of two auto-injectors doubles the BOM cost, but that is a small fraction of the average transaction cost or retail cost. Mylan smartly switched to selling in packs of two to capitalize on the updated guidelines, I suspect to make their cost increases more defendable. I don't like their profiteering, but I can't fault their marketing decision.
> Should pharmacists be able to substitute the AdrenaClick with the patients approval? The law prevents that. Perhaps trusting pharmacists (a highly regulated profession already) to make that decision would be better than patients purchasing fewer EpiPens due to cost.
Generally speaking, I think pharmacists in the US should have an enhanced role in patient care, similar to their counterparts overseas. They are highly trained, as you rightfully point out, and they generally have a better understanding of pharmaceuticals and interactions than their MD colleagues. In this case, they are already able to point out to a prescribing physician that alternatives like Adrenaclick exist, they just cannot modify the script on their own. Actually, this might be a case where electronic prescribing systems make things worse by limiting the physician/pharmacist interaction.