DR. MOHLER: A true story of greed, feisty pregnant women and the FDA doing the right thing
July 2, 2013
A pharmaceutical company, KV, armed with the exclusive rights to an FDA-approved drug that prevents premature births, slaps a big price tag on their "new" drug, Makena. At $1,500 a dose, the company stood to make a huge profit. To ensure that profit, the company sends a "cease and desist" letter to the pharmacies, who for years were compounding the generic equivalent of Makena at $10-$15 a dose.
But then something happens that the drug maker, KV, didn't count on. The patients were used to getting their doses of the drug 100-150 times less expensively. Those expectant mothers and their doctors fight back. The drug company tries to soothe the mother hens' ruffled feathers. It offers co-payment assistance, but these mothers and their doctors are outraged. They paint a very unflattering picture of KV to the media. They pressure the drug company to cut its price, but the company resists.
Then the FDA rides into the fray. The agency doesn't have the power to tell KV to lower the price, but it can allow compounding pharmacists to keep on making their version of the new, expensive drug, and sell it at its old, much more affordable price. And that's just what the FDA did.
• Although there are clear benefits to having an FDA-approved version of a drug, there is no evidence that Makena is safer or more effective than the compounded version.
• In fact, the evidence used to obtain FDA approval for Makena relied primarily on data obtained using the compounded product.
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• Kudos to the FDA for doing "the right thing."
• KV wins the Pharmaceutical Outrage of the Decade Award.
Dr. Mohler has practiced family medicine in Grand Junction for 38 years. He has a particular interest in pharmaceutical education. Phil works part-time for both Primary Care Partners and Rocky Mountain Health Plans. Email him at email@example.com.
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