FDA counters KV s premature warning against compounding early-labor prevention drug

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KV pharmaceuticals recently won exclusive rights to the marketing of the pre-term labor prevention drug they’ve branded Makena. Priced at a whopping $1500 per shot, the therapy may cost up to $30,000 per pregnancy since it usually requires 20 weekly injections to prevent premature labor in patients who have a predisposition to or a history of going into premature labor. The company subsequently began to circulate warning letters to pharmacies — who until now have been compounding (in-house, made-to-order preparation) the drug for about $20 per dose — to stop making the drug or be prepared for FDA legal action. But it looks like KV jumped the gun because the FDA, in an unusual decision, has opted to allow pharmacies to continue mixing the drug themselves — as long as the patient provides a valid prescription, and the drug is made under safe and sterile conditions.

“It looks like the FDA has taken offense to the huge price hike being imposed by KV,” says ACSH's Dr. Gilbert Ross. “I don’t remember the FDA ever going out of its way to say ‘not so fast!’ to a drug company, but if ever a company was asking for it, this is the case.”