FDA to Review Data on Compounded Versions of Makena

FDA to Review Data on Compounded Versions of Makena

From MedScape Ob/GYN and Women’s Health

November 9, 2011 — The US Food and Drug Administration (FDA) will evaluate manufacturer data on the potency and purity of compounded hydroxyprogesterone caproate (Makena, K-V Pharmaceuticals), according to a statement they released today.

On February 3, 2011, the FDA approved Makena as a specialty injectable for women with a singleton pregnancy before 37 weeks’ gestation who have had at least 1 spontaneous preterm birth. This agent is now available through a network of specialty pharmacies and distributors that specialize in distributing specialty injectables and represents an alternative to the compounded agent.

In March 2011, the manufacturer of Makena, K-V Pharmaceuticals, sent letters to pharmacists indicating that the FDA will no longer exercise enforcement discretion with regard to compounded versions of hydroxyprogesterone caproate, and in their letter implied that continuing to compound the drug may result in FDA enforcement action.

At that time, however, the FDA called the warning erroneous and said that “in order to support access to this important drug, at this time and under this unique situation, it does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate.”

More recently, in October 2011, K-V Pharmaceuticals submitted data to the FDA regarding the potency and purity of samples of bulk hydroxyprogesterone caproate active pharmaceutical ingredients (APIs) and compounded hydroxyprogesterone caproate products.

The FDA notes that according to the analysis of this information provided by K-V, there is variability in the purity and potency of both the bulk APIs and compounded hydroxyprogesterone caproate products that were tested.

“Although FDA has not validated or otherwise confirmed the analyses provided by K-V, FDA has carefully reviewed the data and will conduct an on-site review of the laboratory analyses,” they note.

“In the meantime, we remind physicians and patients that before approving the Makena new drug application, FDA reviewed manufacturing information, such as the source of the API used by its manufacturer, proposed manufacturing processes, and the firm’s adherence to current good manufacturing practice,” they state. “Therefore, as with other approved drugs, greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product.”

Since the drug’s approval, the manufacturer of hydroxyprogesterone caproate has been under scrutiny from various groups for pricing the injection too high relative to the cost of the compounded product available from a pharmacy — at one time the price was about $1500 per Makena injection vs $10 to $20 per injection for a compounded version.