Preterm Birth: When an Ounce of Prevention Is Too Expensive

The search for preventive measures to lower risk for preterm birth has centered on progestins ever since, in 2003, injectable 17α-hydroxyprogesterone caproate (17-OHP) was shown to improve delivery outcomes in women with histories of preterm birth (JW Womens Health Aug 19 2003). Soon thereafter, use of supplemental progesterone became widespread — and, in the absence of an FDA-approved, commercially available product, most healthcare providers relied on compounding pharmacies to provide 17-OHP. The most widely used dose is 250 mg (intramuscular) weekly, which was the dose in the 2003 trial.

The recent FDA approval of KV Pharmaceutical's 17-OHP (Makena) precipitated an even greater potential problem with access when KV announced its intention…