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 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 poor people don't deserve those same options?

For years, a drug given to high-risk pregnant women to prevent premature births has cost $10 to $20 per injection. Next week, the price shoots up to $1,500, meaning the total cost during a pregnancy could be as much as $30,000.

The drug, a form of progesterone given as a weekly shot, has been made cheaply for years, mixed in special pharmacies that custom-compound treatments that are not federally approved. But KV Pharmaceutical recently won government approval to exclusively sell the drug, known as Makena (Mah-KEE'-Nah). The March of Dimes and many obstetricians supported that because it means quality will be more consistent and it will be easier to get.

It seems no one anticipated the dramatic price hike.

"That's a huge increase for something that can't be costing them that much to make. For crying out loud, this is about making money," said Dr. Roger Snow, deputy medical director for Massachusetts' Medicaid program.

Doctors say the price hike may deter low-income women from getting the drug, leading to more premature births. And it will certainly be a financial burden for health insurance companies and government programs.

Children born very prematurely may require extensive and expensive hospitalizations, and ongoing therapy and medical assistance, expenses that can drain and/or bankrupt even a well-off family. Will we really be the kind of society that tells people--on the basis of their bank account--that their unborn child doesn't deserve every fighting chance? There was no substantive need to raise the price of Makena so high.

Thankfully, the FDA is going 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.


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