The Epipen fiasco would have been completely avoided if the FDA didn't have the position that it alone, among all regulatory agencies, is qualified to evaluate generic drugs and devices. The sensible thing, which is not being done because the FDA is protecting its turf, is to recognize generic drug approvals from other advanced countries such as the European countries and Canada. The Epipen has a de-facto monopoly due to FDA foot-dragging.
The FDA, ad nauseam, trots out the Thalidomide tragedy to prove that everyone else in the world is incompetent, but the world has changed since 1957, and people can and have learned from their mistakes. Now it's the FDA that's incompetent, introducing needless delays in approving drugs that have already been fully vetted elsewhere.