FDA opens up competition for pregnancy drug

[The Hitman]

Source: LA Times

The Food and Drug Administration took the unusual step Wednesday of inviting specialty pharmacies to make an end run around a company that obtained exclusive rights to a pregnancy drug and promptly raised the price from $20 a dose to $1,500.

The drug, a synthetic form of progesterone trade-named Makena, is recommended as a weekly injection for women at high risk of delivering prematurely, beginning between 16 and 18 weeks' gestation until 36 weeks. The action by K-V Pharmaceutical Co. boosted the total cost of the drug during a pregnancy from about $400 to $30,000, igniting a firestorm of objections.

Then K-V sent letters to pharmacies threatening that the FDA would punish them if they compounded their own versions of the drug. On Wednesday, the FDA declared it would do no such thing.

In its statement, the FDA noted that the drug was important and K-V "received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug's effectiveness."

Read more: http://www.latimes.com/health/la-na-fda-drug-price-20110331,0,992096.story

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It's nice to see the FDA go in and crush this ridiculous price gouging!

[groundloop]

1. WOW... Sanity prevails. Yet another sign that adults are in back in charge