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FDA Reverses Exclusivity Policy for Pregnancy Drug After Enormous Price Hike

Time to mix in a good news story.

A few weeks back, the Food and Drug Administration gave exclusive rights for a pregancy drug named Makena that prevented premature births to KV Pharmaceuticals. They promptly raised the price for Makena, which needs to be injected weekly between 16 and 36 weeks of pregnancy, from $10 to $1,500 a dose. The American Congress of Obstetricians and Gynecologists recommend this drug for any woman who has had a premature birth; there are 500,000 premature births annually in the United States. This was a drug, by the way, funded by public money for research and development and clinical trials.

This sparked outrage from consumer advocates, and in Congress, from Sherrod Brown (D-OH). He sent a letter on March 10 demanding that KV Pharmaceuticals reverse the price hike. He wrote the FTC seeking an anti-trust investigation. He called for a federal investigation on March 25. And in a hearing yesterday, Brown asked HHS Secretary Kathleen Sebelius about the issue.

Brown got results.

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 )NOTE: Sen. Brown’s office maintains that the original price was $10 -ed.) […]

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.”

Until early this year, women obtained the drug from so-called compounding pharmacies, which produced it on a made-to-order basis. Although custom-made for each patient, it sold for about $20 a dose.

Basically, the FDA won’t enforce any blocking of pharmacies that sell their own compounds of Makena. KV responded by saying they would “do more” to make the drug affordable.

Sen. Brown reacted in a press release:

“FDA’s announcement is a victory for pregnant women, consumers, and taxpayers,” Brown said. “This drug, which was developed with extensive taxpayer support, is too important to fall out of reach for pregnant women.”

“I applaud FDA’s action to ensure that the safe and affordable version of this drug remains available. However, FDA never should have had to take this action in the first place,” Brown continued. “FDA approval of a drug should not mean a 15,000% percent increase in the price of a drug – especially when the drug company received significant assistance from taxpayers in developing the product, including research funded by NIH. FDA’s decision to allow the affordable version of this drug to remain on the market is important for women and children, but I remain very upset that KV Pharmaceuticals has acted in such an irresponsible way as to force this action.”

This is a way that public officials can be successful without necessarily passing a law – by raising the public profile of an issue, hounding both the offending entity and their regulators, and forcing a change in policy. Good for Sherrod Brown.

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David Dayen

David Dayen

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