KV Pharmaceutical got the exclusive right to market Makena, a hydroxyprogesterone caproate injection to prevent premature births, and then jacked price from $10 to $1500 a shot. It is now trying to stop compounding pharmacies from making it. The news article says:
"By receiving 'orphan drug status,' KV’s subsidiary Ther-RX Corp. will now be 'the sole source of the drug for seven years.' In justifying the 14,900 percent price hike, KV Pharmaceuticals says that pregnant women will be willing to pay the new price because if they don’t, they could have a premature baby, or 'preemie,' which could cost much much more."
"Last month, KV sent out a letter to compounding pharmacies to cease and desist from producing the drug. KV claims that because the FDA designation now makes Makena 'commercially available,' 'continuinig to compound this product after FDA-approval of Makena renders the compounded product subject to FDA enforcement of violating certain provisions of the Federal Food, Drug and Cosmetic Act, as well as FDA guidance.'"
"By receiving 'orphan drug status,' KV’s subsidiary Ther-RX Corp. will now be 'the sole source of the drug for seven years.' In justifying the 14,900 percent price hike, KV Pharmaceuticals says that pregnant women will be willing to pay the new price because if they don’t, they could have a premature baby, or 'preemie,' which could cost much much more."
"Last month, KV sent out a letter to compounding pharmacies to cease and desist from producing the drug. KV claims that because the FDA designation now makes Makena 'commercially available,' 'continuinig to compound this product after FDA-approval of Makena renders the compounded product subject to FDA enforcement of violating certain provisions of the Federal Food, Drug and Cosmetic Act, as well as FDA guidance.'"
