In recent years there have been a few high profile situations in which the price of a medicine has jumped sharply and suddenly, after decades of availability at a much lower price. In some of these cases — like the case of gout treatment colchicine, which went from 10 cents to five dollars per pill in 2011 — the sudden price increase relates to FDA’s “unapproved drugs initiative.” This refers to the agency’s approach to removing unapproved new drugs from the U.S. marketplace.
This blog entry explains the back story and the public policy conundrum that merits some attention.