Astonishing

[catsittingstill]

A drug for high-risk pregnant women has cost about $10 to $20 per injection. Next week, the price shoots up to $1,500 a dose, meaning the total cost during a pregnancy could be as much as $30,000

Comments

[randwolf]

It does have the look of a fix, doesn't it? My mother's family is from St. Louis; the city has an offbeat culture of corruption and racism that I only know a bit about. I wonder just who in the FDA made the decision.

$1500 Makena Shots

[anonymous]

KV Pharmaceutical's monopoly should be ended and the politicians that gave it to them should be investigated. Possibly it was the 30% increase in stock price or future campaign contributions that prompted the move. The whole situation is utterly disgusting!!!!!

[filkertom]

Big Pharma is, like so many of the other corporate monsters, becoming more brazen every day. I don't even know what they intend to do with all the money -- at the levels they're playing at, it's basically going for a high score.

[billroper]

If you read the article carefully, this looks like an FDA problem to me. (I have numerous problems with the FDA.)

The company apparently is dropping more than a hundred million dollars on a research study into the drug's efficacy. That's why the FDA has handed them a monopoly on the drug under the Orphan Drug Act.

The question of whether the study was needed, given that the drug was commonly used for this problem already and appeared to be effective, is a damn fine one. But note that the FDA almost always errs on the side of having more studies. And given the long-term effects of drugs like DES that were commonly prescribed to pregnant mothers (not to mention the better-known Thalidomide), you can sort of understand their position.

I disagree with their position. However, they're incented to be risk-averse. And this is risk-averse behavior taken to a stupid extreme...

[catsittingstill]

When I read the article carefully, I note the *source* for the claim that the company is spending so much on research.

I don't want to seem cynical, but I would like to see that information verified by someone who doesn't stand to make a %14,900 profit.

Then we can fiddle with questions like "is the FDA being unreasonable to want more studies on a drug that has already been approved?"

[billroper]

I know that drug efficacy studies can be ungodly expensive. And I'm going to make a reasonable guess that the FDA has a good idea of what this particular study is costing.

[catsittingstill]

The *FDA* didn't say anything about how much the study would cost, at least not in this article. The president of the company that plans to charge $1,500 per $10 shot was the source of this claim.

[hsifyppah]

Unfortunately, just revoking the "exclusive" part of their license to manufacture it wouldn't allow the cheap versions to reappear - compounding pharmacies are not allowed to make any product that is available commercially, with very few exceptions - if the commercial product is backordered and temporarily unavailable, or if you are making a variation for medical reasons, eg, a preservative-free version for a patient with an allergy. This has not to do with patents and licenses so much as regulations involving who is considered a manufacturer, and the legal scope of practice of small-scale compounders. Major changes to the laws that govern compounding would be required in this case. Meanwhile, the FDA takes a somewhat hostile stance toward compounding pharmacies, very aggressively going after pharmacies who, as they see it, try to circumvent their regulatory authority by making products that the FDA has not approved. For instance, breastfeeding moms used to be able to buy compounded domperidone, a harmless stomach drug which is

[jenrose1]

So tell me... should the fact that they're making it in a base of castor oil be making me raise my eyebrows? Castor oil put me into labor twice, but I'm assuming that it works by mechanically irritating the intestine, which wouldn't apply to a shot?

[hsifyppah]

Castor oil works directly in the intestine, yes, by drawing fluid in to the bowel and thus indirectly stimulating muscle contractions. That hygroscopic effect wouldn't amount to anything when injected, even if you used a comparable amount to the oral dose, which of course you wouldn't, ouch! It's generally pretty inert and not a common allergen, making it more suitable than the peanut oil base that some other progesterone preparations are made with, IMHO.

[jenrose1]

I've taken the peanut oil progestrone preparations in the past. I suppose that injection is the only way?