I don't like where this whole 'preventative drug' thing is headed. That's just UGLY.
Could there ever be some sort of fallout from this making EpiPens themselves being pulled from the market in America (if, say, Mylan's rights to produce it are revoked)? Or tarnishing the brand for us in other countries that have no other option? EpiPen here is made by another company, yes, but could this ugly investigation somehow affect the EpiPen brand elsewhere? (Because it kind of makes me nervous. There are no generics or alternatives here. At all.)
I don't think so, space. The worst I anticipate for Mylan is predicated on antitrust and accounting or market irregularities that would result in fines and increased oversight. The FDA is certainly part of this equation as it is the sole entity that can approve competitors. Likely some personnel will be be removed as a result to appease the public and some products stuck in the pipeline may be prioritized or fast-tracked. Administration and government oversight is my gig, not pharm
per se, therefore I leave that to the appropriate subject-matter experts.
Mylan should be barred from filing citizen petitions against autoinjector competitors, particularly generics, based on its monopoly status. They will be more heavily regulated, but not run out of business. Sunshine is the best disinfectant, as the saying goes. I'm more curious about what will happen to their patent claims in the next five years. If my understanding is correct they have very little novel additions to the original design other than what really amounts to ancillary functions, such as needle cover. Delivery, needle length, mechanics, storage of liquid, and shelf life are relatively unchanged from the original military innovation for field injection by laypersons under duress.