The Supreme Court said Friday, 14 April 2023, that it would keep federal rules for using an ab0rtion drug in place while it takes time to think more deeply about the problems brought up in a court challenge.
In an order signed by Justice Samuel Alito, the court put the fast-moving case on hold for five days so that the judges could decide if lower court decisions limit the Food and Drug Administration’s approval of the drug mifepristone should be allowed to take effect in the short term.
At this point, the judges are only being asked to decide which parts of a decision from April 7 by U.S. District Judge Matthew Kacsmaryk in Texas, which was changed by appeals ruling on Wednesday, can still be used while the case is still going on. The order ends at the end of the day on Wednesday, so it seems likely that the court will decide by then.
Less than a year after conservative judges overturned Roe v. Wade and let more than a dozen states ban ab0rtion outright, the court is in a new fight about ab0rtion.
The government of President Joe Biden and Danco Laboratories, which makes the pill and is based in New York, asked the judges to step in.
A lawyer for the anti-ab0rtion doctors and medical groups fighting over mifepristone said Friday that the court’s move was “standard operating procedure” and asked the judges to let the changes ordered by the appeals court go into effect by the middle of next week.
An administrative stay, the type of order the court made on Friday, is not usually a sign of what the justices will do next. Alito signed it because he is in Texas and deals with emergency cases. Alito also wrote the decision to remove Roe v. Wade last year.
The Justice Department and Danco both said that “regulatory chaos” and harm to women could happen if the high court doesn’t stop the lower-court decisions that tightened FDA rules about how mifepristone can be administered and sold.
If the court hadn’t done anything, the new rules would have gone into effect on Saturday.
“This application concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone,” Solicitor General Elizabeth Prelogar, the Biden administration’s top Supreme Court lawyer, wrote Friday, less than two days after the appellate ruling.
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Now, the Biden administration and Danco want a more permanent order to keep the current rules in place as long as the court fights over mifepristone. As a backup plan, they asked the court to take up the problem, hear the cases, and decide by early summer on a civil challenge to mifepristone that anti-ab0rtion doctors and medical groups made last year.
Rarely makes the court move so quickly to give a full review of a case before at least one appeals court has carefully looked at the law problems.
A decision from the 5th U.S. Circuit Court of Appeals late Wednesday would make it illegal to mail or order the pill, which is the most popular way to get an ab0rtion, without first seeing a doctor in person. It would also take away the permission from the Food and Drug Administration to use mifepristone after the seventh week of pregnancy. The FDA says that it is safe for ten weeks.
Still, the appeals court did not completely remove the FDA’s approval of mifepristone because the fight over it is ongoing. The 5th Circuit cut down on U.S. District Judge Matthew Kacsmaryk’s April 7 decision, which would have stopped the FDA from approving the pill because it was so broad and rarely done before. He gave the government a week to make a plea.
“As far as the government knows, this is the first time a court has overturned the FDA’s conditions for approving a drug because it disagrees with the agency’s opinion about safety, and it’s the first time it’s done so after those conditions have been in place for years,” wrote Prelogar.
Erin Hawley, a lawyer for the challengers, said in a statement that the FDA’s moves on drug ab0rtion were driven more by politics than by health issues.
“The 5th Circuit correctly told the agency to put women’s health first by putting back important safeguards,” said Hawley, a senior counsel with Alliance Defending Freedom. This conservative legal group fought to overturn Roe v. Wade.
Mifepristone is used with another drug called misoprostol. It was cleared by the FDA more than 20 years ago. Since Judge Kacsmaryk’s decision overturns a federal drug approval, if it is confirmed at the end of the appeals process, it will be used everywhere, even in places where ab0rtion is still allowed.
That has left Democratic lawmakers in places where ab0rtion is legal trying to figure out what to do. The Department of Corrections and the University of Washington in Washington State have stored 40,000 doses of mifepristone, which is enough for four years.
A different federal judge in Washington, D.C., clarified his order from last week on Thursday to make it clear that the FDA is not to do anything that could stop mifepristone from being available in the 17 Democratic-led states that are fighting to keep it on the market. This added to the confusion.
In both cases, it’s unclear how the FDA can follow court orders, which Prelogar called “untenable” on Friday.
After the FDA changed its rules in 2016, the number of women using ab0rtion pills went up a lot, according to a a study from the Guttmacher Institute, which promotes ab0rtion rights. In 2017, 39% of ab0rtions were done with pills. By 2020, this number had grown to 53% of all ab0rtions, making it the most popular way to get an ab0rtion.
Experts say that the number of ab0rtions done with drugs has gone up since the court rejected Roe.
When the FDA first cleared the drug, it could only be used for the first seven weeks of pregnancy. It also needed three visits to the doctor’s office: the first to give mifepristone, the second to give misoprostol, and the third to deal with any problems. It also needed to be overseen by a doctor and have a way to report any significant side effects.
If the appeals court’s decision stands, the same rules will apply to giving out mifepristone.
The central claim in the Texas case is that the FDA’s original approval of mifepristone was wrong because the agency did not look into safety risks enough.
Over the past 23 years, millions of women have used mifepristone. Even though the new ruling isn’t as bad as taking the drug’s approval away totally, it is still a big blow to the FDA’s ability to control how prescription drugs are used in the U.S. After years of scientific study, FDA officials have made several choices that were undone by the ruling on Wednesday night.
Some of the most common side effects of mifepristone are bloating, bleeding, feeling sick, having a headache, or having diarrhea. In rare cases, women can have too much blood to be stopped by surgery.
Still, the FDA’s decision to loosen limits on mifepristone was based on “exceedingly low rates of serious adverse events.”
As of June 2022, the FDA said that more than 5.6 million women in the U.S. had used the drug. During that time, the agency heard from 4,200 women who had problems after taking the medication. This is less than 1% of the women who took the pill.
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