The Society for Maternal-Fetal Medicine (SMFM) praises the FDA's announcement on Makena. FDA has allowed certain pharmaceutical companies to compound hydroxyprogesterone caproate also known as 17p.
"The Society for Maternal-Fetal Medicine commends the FDA on its recently released position that it will exercise enforcement discretion with respect to compounding hydroxyprogesterone caproate," stated George Saade, president of SMFM. "This action will ensure that this life-saving treatment will continue to be available for all those who need it. Affordable access to hydroxyprogesterone caproate is critical in ensuring the health and full-term birth of babies in the U.S."
Typically, once a drug is approved by the FDA, pharmacy compounding is no longer allowed. The FDA stated that KV Pharmaceuticals had sent "letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena." The FDA statement goes on to state that "This is not correct."
"When you consider that the ideal treatment for these at-risk women is administered during weeks 16-36 of pregnancy, under KV Pharmaceuticals dramatic increase the total cost for treatment per pregnancy could soar as high as $30,000," Saade further explained. "This financial barrier could discourage and lockout at-risk women, especially low income women, from receiving this life-saving injection. The FDA announcement will allow all women to continue to receive affordable treatment."