US appellate judges uphold some restrictions on abortion drug in case bound for Supreme Court
By KEVIN McGILL Associated Press
NEW ORLEANS (AP) — Mail-order access to a drug used in the most common form of abortion in the U.S. would end under a federal appeals court ruling issued Wednesday that cannot take effect until the Supreme Court weighs in.
The decision by three judges on the 5th U.S. Circuit Court of Appeals in New Orleans overturned part of a lower court ruling that would have revoked the Food and Drug Administration’s 23-year-old approval of mifepristone. But it left intact part of the ruling that would end the availability of the drug by mail, allow it to be used through only the seventh week of pregnancy rather than the 10th, and require that it be administered in the presence of a physician.
Those restrictions won’t take effect right away because the Supreme Court previously intervened to keep the drug available during the legal fight.
The panel’s ruling would reverse changes the FDA made in 2016 and 2021 that eased some conditions for administering the drug.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Judge Jennifer Walker Elrod wrote for a panel of three 5th Circuit judges. She was joined by Judge Cory Wilson. Judge James Ho dissented, arguing to fully uphold a Texas-based federal judge’s April ruling that would revoke the drug’s approval, which the FDA granted in 2000.
The Biden administration said it would appeal. “As the attorney general has said before, the Justice Department is committed to defending the FDA’s scientific judgment and protecting Americans’ access to safe and effective reproductive care,” a statement from the Justice Department said.
The Center for Reproductive Rights said the ruling, if upheld, would “make it much more difficult for patients to get abortion care in most states.”
Abortion opponents hailed the ruling, although they, too, might appeal to seek full revocation of the FDA’s approval of the drug.
“Mail-order abortion pills put thousands of women and girls at risk of serious complications from abortion pills every year,” said a statement from Katie Daniel of the anti-abortion group Susan B. Anthony Pro-Life America.
Erin Hawley, an attorney for the Alliance Defending Freedom, which filed the Texas lawsuit, said her organization had not yet decided whether to appeal to the Supreme Court to try to get mifepristone’s approval fully revoked. The conservative Christian legal group was also involved in the Mississippi case that led to the June 2022 Supreme Court ruling overturning Roe v. Wade and the nationwide right to abortion.
There is virtually 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.
An attorney for drugmaker Danco Laboratories, which argued in favor of upholding the FDA approval and revisions, did not immediately respond to an email from The Associated Press seeking comment. Drugmaker GenBioPro, which was not part of the lawsuit, noted that the ruling would keep its generic mifepristone available, subject to the restrictions.
Elrod’s opinion said the full revocation of FDA’s approval of the drug was likely barred by legal time limits. Ho argued that the approval violated the 19th century Comstock Act. He also said the FDA gave the green light to mifepristone under a law that allows approval for drugs that treat serious or life threatening illness. “Pregnancy is not an illness,” Ho wrote.
During a May 17 hearing, the 5th Circuit panel pushed back frequently against assertions that U.S. District Judge Matthew Kacsmaryk’s April 7 ruling was unprecedented and unwarranted.
Kacsmaryk, Ho and Wilson are all appointees of former President Donald Trump. Elrod was appointed to the 5th Circuit by former President George W. Bush. All of the judges have a history of supporting abortion restrictions.
Mifepristone is one of two pills used in medication abortions. The other drug, misoprostol, is also used to treat other medical conditions. 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.
FDA panel backs over-the-counter birth control pill
AP Photo/Jacquelyn Martin
The Supreme Court initially gave itself a deadline of Wednesday to decide whether women seeking access to a widely used abortion pill would face more restrictions while a court case plays out. But on the day of the highly anticipated decision the justices had only this to say: We need more time.
In a one-sentence order, the court said it now expects to act by Friday evening. There was no explanation of the reason for the delay.
The new abortion controversy comes less than a year after the Supreme Court's conservative majority overturned Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright.
The following is a look at the drug at issue in the new case, how the case got to the nation's highest court and what the delay might say about what's going on.
AP Photo/Jacquelyn Martin
The Supreme Court initially gave itself a deadline of Wednesday to decide whether women seeking access to a widely used abortion pill would face more restrictions while a court case plays out. But on the day of the highly anticipated decision the justices had only this to say: We need more time.
In a one-sentence order, the court said it now expects to act by Friday evening. There was no explanation of the reason for the delay.
The new abortion controversy comes less than a year after the Supreme Court's conservative majority overturned Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright.
The following is a look at the drug at issue in the new case, how the case got to the nation's highest court and what the delay might say about what's going on.
FDA panel backs over-the-counter birth control pill
AP Photo/Allen G. Breed, File
Mifepristone was approved for use by the Food and Drug Administration more than two decades ago. It has been used by more than 5 million women to safely end their pregnancies, and today more than half of women who end a pregnancy rely on the drug, the Justice Department said.
Over the years, the FDA has loosened restrictions on the drug's use, extending from seven to 10 weeks of pregnancy when it can be used, reducing the dosage needed to safely end a pregnancy, eliminating the requirement to visit a doctor in person to get it and allowing pills to be obtained by mail. The FDA also approved a generic version of mifepristone that its manufacturer, Las Vegas-based GenBioPro, says makes up two-thirds of the domestic market.
Mifepristone is one of two pills used in medication abortions, along with misoprostol. Health care providers have said they could switch to misoprostol only if mifepristone is no longer available or is too hard to obtain. Misoprostol is somewhat less effective in ending pregnancies.
AP Photo/Allen G. Breed, File
Mifepristone was approved for use by the Food and Drug Administration more than two decades ago. It has been used by more than 5 million women to safely end their pregnancies, and today more than half of women who end a pregnancy rely on the drug, the Justice Department said.
Over the years, the FDA has loosened restrictions on the drug's use, extending from seven to 10 weeks of pregnancy when it can be used, reducing the dosage needed to safely end a pregnancy, eliminating the requirement to visit a doctor in person to get it and allowing pills to be obtained by mail. The FDA also approved a generic version of mifepristone that its manufacturer, Las Vegas-based GenBioPro, says makes up two-thirds of the domestic market.
Mifepristone is one of two pills used in medication abortions, along with misoprostol. Health care providers have said they could switch to misoprostol only if mifepristone is no longer available or is too hard to obtain. Misoprostol is somewhat less effective in ending pregnancies.
FDA panel backs over-the-counter birth control pill
Senate Judiciary Committee via AP
A lawsuit over mifepristone was filed in Amarillo, Texas, late last year. Alliance Defending Freedom, a conservative Christian legal group, represents the pill's opponents, who say the FDA's approval of mifepristone was flawed.
Why Amarillo? U.S. District Judge Matthew Kacsmaryk (pictured), who was nominated by then-President Donald Trump, is the sole district court judge there, ensuring that all cases filed in the west Texas city land in front of him. Since taking the bench, he has ruled against President Joe Biden's administration on several other issues, including immigration and LGBTQ protections.
On April 7, Kacsmaryk issued a ruling that would revoke the FDA's approval of mifepristone, but he put the decision on hold for a week to allow an appeal.
Complicating matters, however, on the same day Kacsmaryk issued his order, a court in Washington state issued a separate ruling in a lawsuit brought by liberal states seeking to preserve access to mifepristone. The Washington judge, Spokane-based Thomas O. Rice, whom then-President Barack Obama nominated, ordered the FDA not to do anything that might affect the availability of mifepristone in the suing states. The Biden administration has said it is impossible to follow both judges' directives at the same time.
Senate Judiciary Committee via AP
A lawsuit over mifepristone was filed in Amarillo, Texas, late last year. Alliance Defending Freedom, a conservative Christian legal group, represents the pill's opponents, who say the FDA's approval of mifepristone was flawed.
Why Amarillo? U.S. District Judge Matthew Kacsmaryk (pictured), who was nominated by then-President Donald Trump, is the sole district court judge there, ensuring that all cases filed in the west Texas city land in front of him. Since taking the bench, he has ruled against President Joe Biden's administration on several other issues, including immigration and LGBTQ protections.
On April 7, Kacsmaryk issued a ruling that would revoke the FDA's approval of mifepristone, but he put the decision on hold for a week to allow an appeal.
Complicating matters, however, on the same day Kacsmaryk issued his order, a court in Washington state issued a separate ruling in a lawsuit brought by liberal states seeking to preserve access to mifepristone. The Washington judge, Spokane-based Thomas O. Rice, whom then-President Barack Obama nominated, ordered the FDA not to do anything that might affect the availability of mifepristone in the suing states. The Biden administration has said it is impossible to follow both judges' directives at the same time.
FDA panel backs over-the-counter birth control pill
AP Photo/Nathan Howard
The Biden administration responded to Kacsmaryk's ruling by asking the New Orleans-based 5th U.S. Circuit Court of Appeals to prevent it from taking effect for now.
Last week, the appeals court narrowed Kacsmaryk's ruling so that the initial approval of mifepristone in 2000 is not affected, for now. But it agreed with him that changes the FDA made to relax the rules for prescribing and dispensing the drug should be put on hold. Those rules included expanding when the drug could be taken and allowing for the drug's delivery through the mail.
The appeals court acted by a 2-1 vote. The judges in the majority, Kurt Engelhardt and Andrew Oldham, are both Trump picks.
The Biden administration and the maker of mifepristone, New York-based Danco Laboratories, appealed to the Supreme Court, saying that allowing the appeals court's restrictions to take effect would cause chaos. Facing a tight deadline, the Supreme Court gave itself some breathing room and issued an order suggesting it would act by Wednesday evening. That timeline was extended to Friday, the day the justices will hold a previously scheduled private conference.
The justices could talk about the issue further then. The additional time could also be part of an effort to craft an order that has broad support among the nine justices. Or one or more justices might be writing a separate opinion and asked for a couple of extra days.
About the photo: Laura Meyers, CEO of Planned Parenthood Metropolitan Washington DC, speaks during a Planned Parenthood rally in support of abortion access outside the Supreme Court on Saturday, April. 15, 2023, in Washington.
AP Photo/Nathan Howard
The Biden administration responded to Kacsmaryk's ruling by asking the New Orleans-based 5th U.S. Circuit Court of Appeals to prevent it from taking effect for now.
Last week, the appeals court narrowed Kacsmaryk's ruling so that the initial approval of mifepristone in 2000 is not affected, for now. But it agreed with him that changes the FDA made to relax the rules for prescribing and dispensing the drug should be put on hold. Those rules included expanding when the drug could be taken and allowing for the drug's delivery through the mail.
The appeals court acted by a 2-1 vote. The judges in the majority, Kurt Engelhardt and Andrew Oldham, are both Trump picks.
The Biden administration and the maker of mifepristone, New York-based Danco Laboratories, appealed to the Supreme Court, saying that allowing the appeals court's restrictions to take effect would cause chaos. Facing a tight deadline, the Supreme Court gave itself some breathing room and issued an order suggesting it would act by Wednesday evening. That timeline was extended to Friday, the day the justices will hold a previously scheduled private conference.
The justices could talk about the issue further then. The additional time could also be part of an effort to craft an order that has broad support among the nine justices. Or one or more justices might be writing a separate opinion and asked for a couple of extra days.
About the photo: Laura Meyers, CEO of Planned Parenthood Metropolitan Washington DC, speaks during a Planned Parenthood rally in support of abortion access outside the Supreme Court on Saturday, April. 15, 2023, in Washington.
FDA panel backs over-the-counter birth control pill
AP Photo/Jacquelyn Martin
The Supreme Court's delay suggests a maddening reality about an institution that ordinarily adheres to a schedule that hasn't changed much in years: Even experts can be in the dark about when the court will decide things and how.
Cases are argued over seven months from October to April, and the most important decisions typically come right before the justices take a long summer break. The court does not say which cases it plans to hand down on a given day, and the court, in a search for consensus, will sometimes pass on the biggest issues it faces and decide a very small legal point.
But nowhere is the uncertainty as great as a separate category of cases that have come to be known as the shadow docket.
Apart from death row inmates seeking 11th-hour reprieves, shadow docket cases generally involve emergency appeals to the justices before lower courts have reached final decisions. That includes the mifepristone case.
When the justices consider this set of cases, they don't usually have a deadline to act. A few years back, an order concerning an elections case in Texas came in the wee hours of a Saturday morning for no reason other than that's when Justice Ruth Bader Ginsburg finished work on her dissenting opinion.
AP Photo/Jacquelyn Martin
The Supreme Court's delay suggests a maddening reality about an institution that ordinarily adheres to a schedule that hasn't changed much in years: Even experts can be in the dark about when the court will decide things and how.
Cases are argued over seven months from October to April, and the most important decisions typically come right before the justices take a long summer break. The court does not say which cases it plans to hand down on a given day, and the court, in a search for consensus, will sometimes pass on the biggest issues it faces and decide a very small legal point.
But nowhere is the uncertainty as great as a separate category of cases that have come to be known as the shadow docket.
Apart from death row inmates seeking 11th-hour reprieves, shadow docket cases generally involve emergency appeals to the justices before lower courts have reached final decisions. That includes the mifepristone case.
When the justices consider this set of cases, they don't usually have a deadline to act. A few years back, an order concerning an elections case in Texas came in the wee hours of a Saturday morning for no reason other than that's when Justice Ruth Bader Ginsburg finished work on her dissenting opinion.
