Remember when KV introduced its FDA approved version of hydroxyprogesterone caproate, Makena, and then promptly drew nearly everyone's ire by jacking price from $20-30 per dose to $1500? Then under pressure dropped price to about $595? Then tried to get FDA (which it should have done) to stop compounders from making the cheaper product still? Not only did the FDA refuse, but KV was subsequently rebuffed by the courts and entered bankruptcy.
Well, the worm is slowly turning it appears. The FDA has cited its first compounder, Village Fertility Pharmacy of Waltham, MA, for making faulty batches of Makena. KV is benefitting from this and the increased oversight and regulation compounders are receiving on the tail end of last year's meningitis fiasco. Plus, KV can now tell physicians (who are potentially liable) to use the approved medication instead of compounders elixirs. And everyone seems more comfortable with a $595 price than previously for the improved quality/safety profile of the product.
This likely could have happened years ago with the egregious "price gouge" introduction, but certainly was also helped by the compounder scandal. KV may actually emerge OK. See Fierce Biotech.
Posted by Bruce Lehr Mar 14th 2013.