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The company’s CEO, Michael Porter, has argued that there is evidence to suggest the drug may work in a narrow population that includes Black women, who have historically been at higher risk of maternal complications. That claim is based on a 2003 study that was used to grant the treatment accelerated approval in the first place. Several Black health groups support keeping Makena on the market for further testing, and the NAACP said it worries pulling the drug may “deepen profound existing maternal and infant health inequities in the U.S.” given the lack of alternatives. (Cha, 10/17)

The maker of the only U.S. drug intended to prevent premature births is making a last-ditch effort this week to keep its medication on the market, even as health regulators insist that it doesn’t work. A Food and Drug Administration meeting that opened Monday comes more than two years after the agency declared the drug ineffective and called for its removal. Drugmaker Covis Pharma has challenged the agency’s conclusion, setting up the highly unusual three-day public hearing. (Perrone, 10/17)