If Kacsmaryk orders the FDA to reconsider the drug's approval, that could trigger a years-long process during which the pill would remain legally available. What happens next will depend on whether Kacsmaryk finds he has the authority to overrule the FDA's decision. The FDA said the pill was deemed safe after extensive studies and use, and that the challenge comes much too late. The groups contend the agency used an improper process when it approved mifepristone in 2000 and did not adequately consider the drug's safety when used by girls under age 18. District Judge Matthew Kacsmaryk to halt sales of mifepristone nationwide – even in states where abortion is legal – while their lawsuit against the FDA proceeds. Wade ruling that established federal abortion rights.Īt a hearing last week in Amarillo, Texas, anti-abortion groups asked U.S. Supreme Court last year overturned the 1973 Roe v. The agency's role in determining mifepristone's future has gotten little notice in a court battle that has drawn widespread attention as the most consequential abortion case since the U.S. Mifepristone is part of a two-drug regimen with misoprostol that accounts for more than half of U.S.

Some of the FDA's options could be politically and legally risky both for the agency and mifepristone suppliers, they said. Even if higher courts upheld a decision against the FDA, the agency could help prevent mifepristone from being immediately withdrawn from the market, these experts said. food and drug law scholars and attorneys, including six who signed onto a brief filed in the Texas case, revealed the agency has the power to delay or soften the blow of a court-ordered ban on the drug or reconsideration of its approval.Īny ruling in the case is expected to be appealed. The FDA declined to comment on the litigation or its next steps. Of the various potential rulings possible in the case involving the abortion pill mifepristone, either of those outcomes would be unprecedented judicial intervention in the agency's regulatory process. Food and Drug Administration to reconsider its 22-year-old approval for a pill used in the most common form of abortion in the United States, or order the approval revoked outright. March 23 (Reuters) - A conservative federal judge in Texas could soon order the U.S.

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