When a woman has previously delivered a baby prematurely, she is at greater risk of experiencing another pre-term delivery (PTD). A medication known as 17P (17-Alpha Hydroxyprogesterone Caproate) has been shown to decrease the risk of pre-term delivery (PTD) in pregnant women with a history of spontaneously giving birth before 37 weeks gestation. Weekly injections of progesterone beginning at 16 to 20 weeks gestation and continuing to 36 weeks gestation reduced the risk of preterm delivery by 34%. "This is the first real success we've had in dealing with the biggest problem in obstetrics, which is preterm birth," said Dr. Paul Meis, professor of obstetrics and gynecology at Wake Forest University.
The American College of Obstetricians and Gynecologists has strongly endorsed the 17P treatment. By carrying the baby to at least 37 weeks, many of the serious health risks associated with prematurity are avoided, and prolonging pregnancy can decrease time spent in a Neonatal Intensive Care Unit. Studies to date have demonstrated that 17P seems to be safe for the fetus when administered in the second and third trimesters.
Until 2006, 17P was commercially available, and since that time, 17P has been provided by compounding pharmacies without any problems related to safety or quality. Therefore, Physicians, patients, compounding pharmacists and insurance companies were shocked when in February 2011, the FDA granted KV Pharmaceuticals marketing exclusivity and notices were sent out that Makena (manufactured 17P) would cost $1,500 per dose, which represented a 50 to 100 fold increase over the cost of compounded 17P, with a gross profit margin of 97.5%. If this situation played out, patients and payers would have suffered a tremendous and unnecessary financial burden. Fortunately, in response to letters from insurance companies and physicians as well as patients and others who were outraged by the cost of Makena, the FDA formally announced that 17P could continue to be responsibly compounded.
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