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the US Food and Drug Administration announced its final decision to withdraw its approval of Makena, a drug approved more than a decade ago to reduce the risk of preterm birth. The FDA says that the drug is not effective and that the benefits of taking it do not outweigh the risk.
“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes – particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Dr. Robert Califf said in a statement. “Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.
