FDA Fights Back In Dispute Over Pricey Drug For Premature Birth

FDA: Power to the pharmacists!

Responding to critics outraged over the exorbitant price of Makena, a new version of a cheaper, older drug to prevent pre-term birth, the FDA issued a statement saying that pharmacists can “compound” the drug themselves, thereby side-stepping the cost controversy surrounding the newly approved medication, marketed by KV Pharmaceuticals, reports NPR’s Health Blog.

Hey, KV Phamaceuticals, that new, $1,500-a-dose drug of yours is about to get some competition!

The Food and Drug Administration said in an unusual statement that it’s quite all right for pharmacists to go ahead and make their own version of the medicine, given by injection to help some women avoid preterm delivery of their babies. Many of them had been doing that for years anyway and charged $20 or less per dose.

But KV, based in St. Louis, pursued formal approval of the medicine, hydroxyprogesterone caproate, to avoid premature deliveries. Starting this month, KV began selling it as Makena at a price of $1,500 a shot. For women who need the drug, given weekly for about 20 weeks, the tab would come to around $30,000, as the Washington Post reported the other day. The price hike led to a backlash from just about everyone except KV shareholders.

Now the FDA has cleared the air about whether pharmacists can make the medicine. The agency’s answer boils down to an emphatic yes.