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FDA Releases Statement on Makena, Going for Less Expensive


Yesterday, the U.S. Food and Drug Administration released a statement on Makena in support of allowing pharmacies to continue compounding a less expensive form of the active ingredient hydroxyprogesterone caproate.

Makena is used for the prevention of preterm labor in women who have already had a miscarriage. The drug had been sold for $10 to $20 per injection by compounding pharmacies for several years.

Last month after KV Pharmaceutical received the FDA approval granting them seven years of exclusivity for the manufacturing of Makena under the Orphan Drug Act, the New England Journal of Medicine published an editorial predicting the cost would skyrocket.

It has. KV Pharmaceutical is charging $1,500 a dose for the drug. A woman might receive up to 20 doses over the course of a pregnancy, totaling $30,000 for Makena but $200 to $400 for the compounded version.

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The FDA’s statement notes it is their right to exercise enforcement discretion with respect to products made through traditional pharmacy compounding. This includes products made from the active ingredient in Makena, hydroxyprogesterone caproate.

The FDA notes the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. The FDA states “This is not correct.”

In order to support access to this important drug, at this time and under this unique situation, 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. As always, FDA may at any time revisit a decision to exercise enforcement discretion.

Because Makena is a sterile injectable, where there is a risk of contamination, greater assurance of safety is provided by an approved product. However, under certain conditions, a licensed pharmacist may compound a drug product using ingredients that are components of FDA approved drugs if the compounding is for an identified individual patient based on a valid prescription for a compounded product that is necessary for that patient. FDA prioritizes enforcement actions related to compounded drugs using a risk-based approach, giving the highest enforcement priority to pharmacies that compound products that are causing harm or that amount to health fraud.

Food and Drug Administration

Unintended Consequences — The Cost of Preventing Preterm Births after FDA Approval of a Branded Version of 17OHP; Joanne Armstrong, M.D., M.P.H.; NEJM | March 16, 2011