Makena, a drug to prevent preterm birth, is the subject of new debate surrounding accelerated approvals by the US Food and Drug Administration, recalling the controversy over the recent fast-tracking of Biogen's Alzheimer's medication Aduhelm, the New York Times reports.
Currently owned by Covis Pharma, Makena has been on the market for a decade, but with evidence emerging that it works no better than a placebo, the FDA last year proposed rescinding its approval.
More than a dozen plaintiffs have also filed a lawsuit against the drug's previous owner, AMAG Pharmaceuticals, demanding the drug be removed from the market.
AMAG is fighting back against the suit and Covis plans to oppose the FDA's proposal at an upcoming agency hearing, arguing that Makena is effective for a subset of women, African Americans, whose rate of preterm birth is much higher than other groups in the developed world.
According to the Times, the debate has divided the maternal-fetal medical care community. AMAG and now Covis have argued that the 2019 study calling Makena's effectiveness into question was underpowered for determining benefit in Black women, and academics like Harvard professor Michael Greene have agreed.
"Is it really fair and equitable to yank the labeled indication for a drug that is helpful to a minority, just because it's not helpful to the majority?" Green tells the Times.
In the meantime, diverging proposals have emerged in Congress — one to make drug approvals easier and more ironclad, and another to give the FDA greater power in scrutinizing and removing fast-tracked drugs that fall short.
FDA spokesperson April Grant tells the Times that FDA is working on systems to keep drugmakers on schedule and that if the agency finds gaps in its authority, it will work with Congress to close those gaps.