Choose Makena Over Compounded Drug, FDA Recommends

July 05, 2012

July 5, 2012 — Clinicians generally should prescribe the FDA-approved form of hydroxyprogesterone caproate (Makena, K-V Pharmaceutical), which reduces the risk for preterm birth, rather than unapproved versions compounded by pharmacies, the US Food and Drug Administration (FDA) has announced.

The FDA guidance, issued last week, is the latest twist in the imbroglio over the economics of preventing premature births.

The agency approved Makena in February 2011 for women with a singleton pregnancy before 37 weeks' gestation who have had at least 1 spontaneous preterm birth. The FDA also gave K-V Pharmaceutical exclusive rights to market the injectable drug through its subsidiary Ther-Rx for 7 years under the Orphan Drug Act, designed to spur development of medications lacking large markets.

Initially, K-V Pharmaceutical set the price of a single injection at $1500, a huge increase over the $10 to $20 for unapproved versions of hydroxyprogesterone caproate that have been compounded for years by pharmacies. In response to cries of price-gouging from physicians and politicians, the drug maker reduced Makena's list price by half in April 2011 and introduced other price breaks. Critics still considered the cost too high. Meanwhile, the FDA said it would not object to pharmacies continuing to compound hydroxyprogesterone caproate. The agency can choose not to block the production of unapproved drug compounds if they meet a public health need and prove safe and effective.

Later in 2011, K-V Pharmaceutical submitted a study to the FDA claiming that compounded versions of hydroxyprogesterone caproate fell short of purity and potency standards. The agency conducted its own study and announced on June 15, 2012, that it had failed to identify "any major safety problems." However, the FDA noted that approved products such as Makena "provide a greater assurance of safety and effectiveness than do compounded products."

The FDA issued more explicit and directive guidance to clinicians last week.

"If there is an FDA-approved drug that is medically appropriate for a patient, the FDA-approved product should be prescribed and used," the agency said. "Makena was approved based on an affirmative showing of safety and efficacy. The company also demonstrated the ability to manufacture a quality product."

The agency did not rule out prescribing compounded versions of hydroxyprogesterone caproate or any other drug. Using them is warranted, it said, if a clinician "has determined that a compounded product is necessary for the particular patient and would provide a significant difference" compared with an FDA-approved product.

However, the FDA also warned that it may take action against compounding pharmacies that not only make unsafe versions of hydroxyprogesterone caproate but also mass-produce the drug, however safe it may be.

"The FDA does not consider compounding large volumes of copies, or what are essentially copies, of any approved commercially available drug to fall within the scope of traditional pharmacy practice," the agency said.

More information on the announcement about Makena can be found on the FDA's Web site.


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