Big Pharma raises the price of a vital, inexpensive drug

From the Los Angeles Times:

The price of a drug used to delay birth in women at high risk of delivering prematurely is going to skyrocket following Food and Drug Administration approval of a prescription form of the product, a synthetic form of the hormone progesterone.

Since 2003, the American Congress of Obstetricians and Gynecologists has recommended that doctors offer the progesterone shots to high-risk women. But because there has not been a commercial product available, women have obtained the drug from so-called compounding pharmacies, which make it to order. The pharmacies have typically charged about $10 to $20 per shot for the drug, which is given weekly.

Last month, however, the FDA approved a commercial form of the drug, called Makena, manufactured by K-V Pharmaceutical Co. of St. Louis. The company said Wednesday that the drug will be available for shipping March 14 and that it will cost $1,500 per dose. The company said, however, that it would establish a "comprehensive patient assistance program" to ensure that the drug was available to every woman who needs it.

You're going to pay for this, whether you use the drug or not.   Oh, and BTW...

Meanwhile, women are unlikely to be able to continue to get the drug at compounding pharmacies. K-V sent letters to the pharmacies warning them of potential FDA action if they keep distributing the drug.

Followup March 23 - a good editorial on this topic:

What's irritating, to someone like me who works at a "find a new drug" type of company, is that these no-name generic outfits (KV in this case, URL Pharma for colchicine) are doing pretty much what critics of the industry think that we all do, all the time. That is, walk up to situations where other people have done a lot of the work, a good amount of it with public/NIH money, and step right in and profit. Now it's true that these companies have to basically run Phase II/Phase III trials to take the data to the FDA, and that's a significant amount of money. But their risks in doing so have been watered down immensely by the history of these drugs in the medical community. When a research company closes its eyes, holds its breath, and jumps into the clinic with a new molecule, that's one thing. And that's where those 90% failure rates come from. But the failure rate of drugs that have been used for years in human patients already, and already studied under clinical conditions, is not anything like 90%. Is it zero per cent? Has anyone failed yet, taking one of these old medications back to the FDA? Even once?

Addendum March 28:  This subject has hit the national popular press and has prompted some scrutiny and investigations.  Here's a followup report by the Washington Post.