FDA Reverse Exclusivity Policy for Pregnancy Drug After Enormous Price Hike


FDA Reverse Exclusivity Policy for Pregnancy Drug After Enormous Price Hike

FireDogLake – 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.) […]

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