Tell Me It's Not Class Warfare: Pharma Ups Cost Of Preemie-Preventative Treatment--From $30 To $1,500!
After having a painful miscarriage some years earlier, I spent a long period of time in my next pregnancy on pins and needles, worried that I might lose another pregnancy. And as it turned out, I did go into labor early. I stayed on bedrest
After having a painful miscarriage some years earlier, I spent a long period of time in my next pregnancy on pins and needles, worried that I might lose another pregnancy. And as it turned out, I did go into labor early. I stayed on bedrest for the last six weeks of the pregnancy and delivered my eldest about 3 weeks earlier than her due date. She was healthy, thank the deity of your choice. But I also had the luxury of having decent insurance, so I knew that I had options in the event that we could not stop the labor from progressive past the point of no return.
So how can you look at this story and not see it as the so-called "free market" deciding that to allow generic versions of the drug
KV Pharmaceuticals recently won FDA approval of its brand-name Makena (hydroxyprogesterone caproate), a synthetic form of the hormone progesterone. The drug is approved to lower the risk of some preterm births in women who have already had at least one previous preterm birth.
The approval seemed to be good news -- until KV announced that Makena would cost $1,500 a shot -- up from the $10 to $15 that compounding pharmacies charge.
After getting the approval, KV sent a letter to compounding pharmacies telling them that the FDA would enforce the company's exclusive right to make the drug.
"This is not correct," the FDA said today.
"In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products," the FDA announced.