Appellate judges with a history of supporting abortion restrictions heard arguments Wednesday over access to a drug used in the most common method of abortion.The closely watched case is likely to wind up at the Supreme Court, which already intervened to keep the drug, mifepristone, available while the legal fight winds through the courts.Three 5th U.S. Circuit Court of Appeals judges heard two hours of arguments in the case Wednesday afternoon. At issue are the Food and Drug Administration’s initial approval of mifepristone in 2000, and FDA actions making the drug more accessible in later years. The judges won’t rule immediately.The case comes to the appeals court almost a year after the Supreme Court overturned the Roe v. Wade ruling that had established abortion rights. Fourteen states have since banned abortion at all stages of pregnancy and other states have adopted, or are debating, major restrictions.Arguing for the Biden administration, Sarah Harrington told the judges that the doctors and groups who brought the lawsuit did not have a right to sue because they won’t have to treat people who have taken mifepristone. All three judges seemed skeptical of that argument.”It just strikes me that what the FDA has done in making this more available … is you’ve made it much more likely that patients are going to go to emergency care or a medical clinic where one of these doctors is a member,” said Judge Cory Wilson, who was nominated by former President Donald Trump.Harrington disputed that, saying that mifepristone is extremely safe, rarely results in complications, and that doctors could cite their conscience and refuse to participate in procedures.Video above: Get the Facts: 1873 Comstock Act used in abortion pill decisionJudge James Ho, another Trump nominee, told a lawyer for mifepristone maker Danco Laboratories, Jessica Ellsworth, that the argument her side was making amounts to the “FDA can do no wrong” and “Nobody should ever question the FDA.””We are allowed to look at the FDA just like we’re allowed to look at any agency. That’s the role of the courts,” said Ho, who went on to say that the FDA has approved drugs later found to have safety problems.Despite Ho’s comments, there is no precedent for a U.S. court overturning the approval of a drug that the FDA has deemed safe and effective. While new drug safety issues often emerge after FDA approval, the agency is required to monitor medicines on the market, evaluate emerging issues and take action to protect U.S. patients. Congress delegated that responsibility to the FDA – not the courts – more than a century ago.The third judge hearing the case is Jennifer Walker Elrod, a George W. Bush nominee.The case began in November. That’s when abortion opponents filed a lawsuit in federal court in Amarillo, Texas, where U.S. District Judge Matthew Kacsmaryk, a Trump nominee, presides. Kacsmaryk issued a ruling on April 7 that would have revoked FDA approval of mifepristone. The Biden administration and Danco Laboratories quickly appealed to the 5th Circuit, seeking a stay of Kacsmaryk’s ruling.Video above: US Supreme Court temporarily preserves access to mifepristone abortion pillAn appellate panel voted 2-1 to narrow, but not completely block, Kacsmaryk’s ruling. The April 13 decision said the abortion opponents appeared to be barred by time limits from challenging the initial 2000 approval. But the panel said the reimposed rules for physician visits and bars on mailing the drug could stay in place.Later, the Supreme Court put the lower court rulings on hold pending appeals, almost certainly leaving access to mifepristone unchanged at least into next year.The rules surrounding mifepristone have changed since the drug’s initial approval. The FDA has extended the time it can be used from seven to 10 weeks of pregnancy, reduced the dosage needed to safely end a pregnancy, eliminated the requirement to visit a doctor in person to get it and allowed pills to be obtained by mail.Mifepristone is one of two pills used in medication abortions, along with misoprostol. Health care providers have said they could switch to misoprostol if mifepristone is no longer available or is too hard to obtain. Misoprostol is somewhat less effective in ending pregnancies.___Associated Press reporters Jessica Gresko and Matthew Perrone contributed to this report from Washington.
Appellate judges with a history of supporting abortion restrictions heard arguments Wednesday over access to a drug used in the most common method of abortion.
The closely watched case is likely to wind up at the Supreme Court, which already intervened to keep the drug, mifepristone, available while the legal fight winds through the courts.
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Three 5th U.S. Circuit Court of Appeals judges heard two hours of arguments in the case Wednesday afternoon. At issue are the Food and Drug Administration’s initial approval of mifepristone in 2000, and FDA actions making the drug more accessible in later years. The judges won’t rule immediately.
The case comes to the appeals court almost a year after the Supreme Court overturned the Roe v. Wade ruling that had established abortion rights. Fourteen states have since banned abortion at all stages of pregnancy and other states have adopted, or are debating, major restrictions.
Arguing for the Biden administration, Sarah Harrington told the judges that the doctors and groups who brought the lawsuit did not have a right to sue because they won’t have to treat people who have taken mifepristone. All three judges seemed skeptical of that argument.
“It just strikes me that what the FDA has done in making this more available … is you’ve made it much more likely that patients are going to go to emergency care or a medical clinic where one of these doctors is a member,” said Judge Cory Wilson, who was nominated by former President Donald Trump.
Harrington disputed that, saying that mifepristone is extremely safe, rarely results in complications, and that doctors could cite their conscience and refuse to participate in procedures.
Video above: Get the Facts: 1873 Comstock Act used in abortion pill decision
Judge James Ho, another Trump nominee, told a lawyer for mifepristone maker Danco Laboratories, Jessica Ellsworth, that the argument her side was making amounts to the “FDA can do no wrong” and “Nobody should ever question the FDA.”
“We are allowed to look at the FDA just like we’re allowed to look at any agency. That’s the role of the courts,” said Ho, who went on to say that the FDA has approved drugs later found to have safety problems.
Despite Ho’s comments, there is no precedent for a U.S. court overturning the approval of a drug that the FDA has deemed safe and effective. While new drug safety issues often emerge after FDA approval, the agency is required to monitor medicines on the market, evaluate emerging issues and take action to protect U.S. patients. Congress delegated that responsibility to the FDA – not the courts – more than a century ago.
The third judge hearing the case is Jennifer Walker Elrod, a George W. Bush nominee.
The case began in November. That’s when abortion opponents filed a lawsuit in federal court in Amarillo, Texas, where U.S. District Judge Matthew Kacsmaryk, a Trump nominee, presides. Kacsmaryk issued a ruling on April 7 that would have revoked FDA approval of mifepristone. The Biden administration and Danco Laboratories quickly appealed to the 5th Circuit, seeking a stay of Kacsmaryk’s ruling.
Video above: US Supreme Court temporarily preserves access to mifepristone abortion pill
An appellate panel voted 2-1 to narrow, but not completely block, Kacsmaryk’s ruling. The April 13 decision said the abortion opponents appeared to be barred by time limits from challenging the initial 2000 approval. But the panel said the reimposed rules for physician visits and bars on mailing the drug could stay in place.
Later, the Supreme Court put the lower court rulings on hold pending appeals, almost certainly leaving access to mifepristone unchanged at least into next year.
The rules surrounding mifepristone have changed since the drug’s initial approval. The FDA has extended the time it can be used from seven to 10 weeks of pregnancy, reduced the dosage needed to safely end a pregnancy, eliminated the requirement to visit a doctor in person to get it and allowed pills to be obtained by mail.
Mifepristone is one of two pills used in medication abortions, along with misoprostol. Health care providers have said they could switch to misoprostol if mifepristone is no longer available or is too hard to obtain. Misoprostol is somewhat less effective in ending pregnancies.
___
Associated Press reporters Jessica Gresko and Matthew Perrone contributed to this report from Washington.
