Good News for Preemies

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Here’s some good news for you. Remember a few weeks ago I wrote a post about a drug that helps prevent premature births? For years, a generic version was widely available from compounding pharmacies for about $10 per shot, but then, based largely on studies performed by the federal government, Hologic Inc. won approval of a branded version of the drug. It promptly sold the marketing rights to K-V Pharmaceutical, which jacked up the price overnight to about $1,500 per shot:

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.”

….”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 [Makena] based on a valid prescription,” the agency said in a statement.

That’s from the Los Angeles Times. It’s not the end of the story, since I assume that K-V will now bring its legal and lobbying muscle to bear in defense of its outrageous pricing. But it’s a good start.

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