Doctors fear that the only drug approved to prevent preterm birth, the nation's leading cause of infant mortality and disability, will no longer be available to expectant mothers.
If Makena stays on the market, doctors and insurers will be left to haggle over prescribing a drug that can cost an average of more than $10,000 per pregnancy. If the FDA blocks further sales, a treatment that many doctors and patients rely on will disappear overnight.Babies born prematurely can have problems breathing or digesting food or experience bleeding in their brains, among other life-threatening risks. Some of the children who survive struggle with lifelong disabilities.
Thus, for more than a decade, compounding pharmacies — specialty pharmacies that typically make prescription drugs for patients who have allergies or other conditions — created cheap injections of 17P for use by pregnant women. At the time, Makena's manufacturer struggled to compete with the cheaper, compounded 17P. In 2012, it sued the FDA in an unsuccessful attempt to stop compounding — gaining some ground later that year when a meningitis outbreak caused by a different compounded drug drew federal scrutiny of specialty pharmacies.
Nearly a decade later, AMAG released the long-awaited findings of that nine-year scientific study: Although the company also turned up no major safety issues, researchers said last fall they could not prove Makena is effective at preventing preterm birth. AMAG told the FDA that it had had difficulty enrolling enough women who fit its criteria in the United States — because if a woman was already taking 17P, generally speaking, then she was not eligible for the study. And because the drug was already considered the standard of care, a lot of American women were taking it.
On Jan. 9, AMAG announced that because of "uncertainty" over Makena, it would divest itself of two of its other drugs, including one that was approved by the FDA last summer.
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