Mar 30, 2011

FDA Says Pharmacies Can Still Compound Generic Makena

Pharmacies can continue to compound generic hydroxyprogesterone caproate for reducing the risk for preterm delivery despite warnings from KV Pharmaceutical — which sells a costly, branded version of the drug — not to do so, the US Food and Drug Administration (FDA) announced today.

On February 3, the FDA approved KV Pharmaceutical’s Makena, an injectable form of hydroxyprogesterone caproate, for women with a singleton pregnancy before 37 weeks’ gestation who have had at least 1 spontaneous preterm birth. The company then announced that it would sell Makena for $1500 per injection — a price that was quickly branded as predatory, especially because many patients would need as many as 20 injections. Critics include the March of Dimes Foundation, several US senators, and medical societies such as the American College of Obstetricians and Gynecologists.

In response, the company announced plans to reduce the drug’s price for needy patients.

Before Makena’s approval, pharmacies across the country had legally compounded hydroxyprogesterone caproate injection because the FDA in this situation chose not to enforce federal law banning unapproved prescription drugs. Compounded versions of Makena have sold for $10 to $20 per injection.

In letters mailed last month, KV Pharmaceutical warned pharmacies that they should no longer compound a generic form of the drug. It contended that because the FDA had now approved Makena, the agency’s past discretionary tolerance of pharmacy-compounded versions was over. Continuing to compound the drug, the letter stated, would break the law and possibly trigger FDA enforcement action.

The FDA said today that KV Pharmaceutical was incorrect in stating that the FDA will “no longer exercise discretionary enforcement” of drug laws regarding compounded versions of Makena.

“In order to support access to this important drug, at this time and under this unique situation,” the agency stated, “FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products.”

In response to an inquiry by Medscape Medical News, a subsidiary of KV Pharmaceutical called Ther-Rx issued a press release stating that “having available an FDA-approved medication is in the best interest of patients.” It also promised to take further steps to give patients “affordable access” to Makena.

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