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A Conspicuous Absence: Professional Societies ACOG, SMFM Missing From Makena Public Hearing

 
• By Sue Sutter

The American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine did not testify at the public hearing on CDER’s proposal to withdraw the preterm birth prevention drug, even though the groups’ clinical guidelines still recommend use of Makena and its active ingredient.

Makena puzzle piece
Two major professional societies were missing from the FDA public hearing on Makena’s accelerated approval withdrawal. • Source: Shutterstock

The US FDA Center for Drug Evaluation and Research’s two-year effort to withdraw Covis Pharma’s Makena and its generics due to efficacy concerns may finally be resonating with professional societies.

The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine previously have testified in support of – and continue to recommend use of – Makena and its active ingredient to prevent recurrent preterm birth

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