[etendue]

I'm not clear as to why you say that alternative injectors were "arbitrarily denied approval": Auvi-Q was voluntarily recalled because it didn't reliably dispense an accurate dose, Teva's was rightfully rejected AB rating because it was not identical to the EpiPen in use, and the FDA is well within it's regulatory scope in requiring Adamis provide a usability study and stress-testing for their pre-filled syringes.

The lack of competition to the EpiPen (note that there are other injectors, just not a generic to the EpiPen) is, as I see it, a statement that even simple medical devices are a hard problem. The problems that these companies have had are quality and design failures (in the PLM sense) that are on the companies to correct.

[gwright]

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.

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.

The government apparently requires purchase of two EpiPens to reduce the risk in case a single dosage is insufficient, but this doubles the cost. Now some people purchase two (one package) instead of four (two packages) and perhaps they won't have any EpiPen at all when they need one because they can't have one at home, at school, at camp, at Grandma's house and so on.

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.

[etendue]

> 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.

[ende]

> Auvi-Q was voluntarily recalled because it didn't reliably dispense an accurate dose

In 26 unconfirmed cases. Auvi-Q wasn't recalled because of device failure, but because of -potential- device failure. EpiPen is not immune to device failure either: http://adc.bmj.com/content/98/Suppl_1/A42.3

The FDA needs to be maintaining a standard in device quality, but it also needs to make those assessments free of any potential bias and it also needs to be held responsible for denying a fair competitive market to consumers.