FDA Intercedes on Preterm Labor Drug Price Gouging

Robin Marty

The federal Food and Drug Association states it will not stop other companies from making a cheaper version of the preterm labor drug Makena.

After numerous reports that KV Pharmaceuticals was planning a drastic price increase now that it had obtained sole rights to a drug designed to stop women from going into labor early, the Food and Drug Administration has announced it will not intervene if other companies make cheaper versions of the medicine.

From the Wall Street Journal:

On Wednesday the FDA said a letter sent by K-V Pharmaceuticals to pharmacists suggesting the agency was going to take action against them for making , or compounding, hydroxyprogesterone caproate “is not correct.”

Typically, whenever a drug is approved, pharmacy compounding isn’t allowed and the FDA acts to remove any unapproved drugs that might on be the U.S. market.

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But, an FDA spokeswoman said Wednesday the situation with Makena is “unique” and done to make sure women have access to needed therapy. Also unusual in the Makena situation, is that the research submitted to FDA in support of Makena was paid for by the National Institutes of Health. Typically companies fund most research into new drugs and medical devices.

The drug, which was previously available at $10 per dose before KV changed the pricing to $1500 per dose, was allegedly going to be offered to lower income women at reduced cost, according to a company spokesperson.  In other words, the company intended to make every woman pay absolutely as much as she could afford in order to obtain it.

So why is the company so desperate to get every last cent it can out of the drug?  As Slate reports, most pharmaceutical companies have stopped developing new drugs and are losing their patents on drugs that currently exist, leaving them with no way to make money.

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