However, the drug has a decadeslong track record of safety, and acomprehensive review conducted by the National Academies of Sciences confirmed that it has a very low rate of serious complications.
The following week, the Fifth Circuit Court of Appeals partially blocked Kacsmaryks decision, allowing the pill to retain its FDA approval but rolling back several changes the agency has made in recent years to expand access to it.
Kacsmaryks ruling circumvents that established process, Sarpatwari says.Manufacturers and the FDA haveremoved drugs from the market before, either because of low demand or dangers to patients, but a court has never stepped in to pull a longapproved drug from use.
Pharmaceutical companies and drug manufacturers say the lower courts rulings represent an unprecedented intrusion into the authority of the FDA.
The court had given itself a deadline of Wednesday by midnight to decide whether the pill would face tighter rules while an appeal moves forward, but it extended that deadline to today.
GenBioPro, the manufacturer of a generic form of mifepristone, entered the fray this week with a lawsuit against the FDA.
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