FDA allows Pharmacy Compounding of Preterm Labor Drug

Apr 04, 2011   

On Wednesday, March 30, 2011, the U.S. Food and Drug Administration (FDA) issued a statement to compounding pharmacies regarding FDAs enforcement discretion with regard to compounded versions of Makena┞¢, KV Pharmaceuticals branded preterm labor drug. As we previously reported, the FDA approved KV Pharmaceuticals Makena┞¢ (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women. After receiving approval, KV Pharmaceuticals began charging $1,500 a dose for a compound that had been available for years for approximately $10 to $20 a dose. The FDA statement is intended to neutralize the public outcry, not only from members of Congress, but from many doctors and medical groups over the huge price increase.

The FDA states that “KV Pharmaceuticals has sent letters to pharmacists indicating that the FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct.” The FDA “does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient [].” This statement goes against the FDAs policy on compounding pharmacies. In Compliance Policy Guide 460.200 on pharmacy compounding, the FDA states it will consider enforcement action when a pharmacy engages in compounding drug products that are commercially available in the marketplace. As a way to explain its change in position with regard to compounding pharmacies, the FDA states that it is not going to take enforcement action in an effort “to support access to this important drug, at this time and under this unique situation.”

Fuerst Ittleman will continue to monitor FDAs enforcement posture for Makena┞¢ and other compounded products. For more information, please contact us at contact@fidjlaw.com.