Supreme Court upholds FDA abortion pill rules for now

washington • The Supreme Court said Friday it was temporarily maintaining federal rules on the use of an abortion drug while it took time to more fully consider issues raised in a court challenge.

In an order signed by Judge Samuel Alito, the court placed a five-day break in the fast-moving case to allow judges to decide whether to allow lower court decisions restricting the Food and Drug Administration’s approval of the drug mifepristone effect in the short term.

Judges are asked at this point only to determine which parts of a June 7 ruling by U.S. District Judge Matthew Kacsmaryk in Texas. The order expires late Wednesday, suggesting the court will rule on this issue by then.

Less than a year after conservative judges reversed Roe v. Wade and allowed more than a dozen states to effectively ban abortion, the court is locked in a new battle over abortion.

[Read more: Abortion care ‘a pretty overwhelming landscape’ in the West after Roe]

President Joe Biden’s administration and New York-based Danco Laboratories, the pill’s maker, have urged the judiciary to intervene.

An attorney for the anti-abortion doctors and medical organizations suing over mifepristone said the court’s lawsuit on Friday was “standard practice” and urged judges to let the changes ordered by the appeals court go into effect by the middle of next week.

The type of order the court issued Friday, an administrative stay, is usually not indicative of what judges will do going forward. It was signed by Alito because he handles emergencies from Texas. Alito is also the author of last year’s report on the fall of Roe v. Calf.

The Justice Department and Danco both warned of “regulatory chaos” and harm to women if the Supreme Court does not block lower court rulings that have tightened FDA rules under which the drug mifepristone can be prescribed and dispensed.

The new limits would have come into force on Saturday if the court had not acted.

“This motion concerns unprecedented lower court orders to overturn the FDA’s scientific judgment and unleash regulatory chaos by suspending the existing FDA-approved terms of use for mifepristone,” wrote Attorney General Elizabeth Prelogar, the Supreme Court’s chief counsel of the Biden administration, on Friday less than two days after the appeal ruling.

The Biden administration and Danco now want a more permanent order that will uphold the current rules as long as the mifepristone litigation continues. In a throwback, they asked the court to take up the matter, hear arguments and rule by early summer on a legal challenge to mifepristone that doctors and anti-abortion medical organizations filed last year.

[Read more: Where Utahns can get an abortion after the clinic ban goes into effect]

The court seldom acts with sufficient speed to grant a full review of cases before at least one appellate court has thoroughly examined the legal issues involved.

A ruling by the US Fifth Circuit Court of Appeals late Wednesday would prevent the pill, used in the most common method of abortion, from being shipped or prescribed without a personal visit to a doctor. It would also revoke the Food and Drug Administration’s approval of mifepristone for use beyond the seventh week of pregnancy. The FDA says it’s safe for 10 weeks.

Still, the Court of Appeals has not fully withdrawn mifepristone’s FDA approval while the dispute over it continues. The Fifth Circuit Court of Appeals limited an April 7 ruling by US District Judge Matthew Kacsmaryk whose sweeping and virtually unprecedented order would have blocked FDA approval of the pill. He gave the administration a week to appeal.

“To the government’s knowledge, this is the first time a court has overruled the FDA’s terms for approval of a drug based on a disagreement with the agency’s judgment on safety — let alone after those terms have been in place for years.” are,” Prelogar wrote.

Erin Hawley, an attorney for the challengers, said in a statement that the FDA has put politics over health concerns in its drug abortion policies.

“The 5th Circuit Court correctly asked the agency to prioritize women’s health by restoring critical safeguards, and we will ask the Supreme Court to uphold that accountability,” said Hawley, a senior attorney with the Alliance Defending Freedom, one conservative rights group, which also does this, argued that Roe v. to fall Wade.

Mifepristone was approved by the FDA more than two decades ago and is used in combination with a second drug, misoprostol.

Adding to the uncertainty, a separate federal judge in Washington on Thursday clarified his own order from last week to clarify that the FDA can’t do anything that might block the availability of mifepristone in 17 Democrat-run states that are suing to use it on the to hold market.

It’s unclear how the FDA can comply with court orders in either case, a situation Prelogar called untenable on Friday.

The use of medical abortions increased significantly after the FDA expanded regulations in 2016, according to data collected by the Guttmacher Institute, a research group that advocates for abortion rights. In 2017, medical abortion accounted for 39% of abortions, but by 2020 it had become the most common method, accounting for 53% of all abortions.

Experts have said the use of medical abortions has increased since the court overthrew Roe.

When the drug was originally approved, the FDA restricted its use to up to seven weeks of pregnancy. Three in-person visits to the office were also required: the first to administer mifepristone, the next to administer the second drug, misoprostol, and the third to treat any complications. It also required medical supervision and a reporting system for any serious consequences of the drug.

Again, if the appeals court’s lawsuit stands, these would be the conditions under which mifepristone could be released for now.

At the heart of the Texas lawsuit is a claim that the FDA’s original approval of mifepristone was flawed because the agency failed to adequately review the safety risks.

Mifepristone has been used by millions of women over the last 23 years. Though less drastic than overturning the drug’s approval outright, the latest ruling still poses a powerful challenge to the FDA’s agency, which oversees how prescription drugs are used in the United States.

Common side effects of mifepristone include cramping, bleeding, nausea, headache, and diarrhea. In rare cases, women may experience excessive bleeding, which may require surgery to stop it.

However, in easing restrictions on mifepristone, FDA regulators cited “extraordinarily low rates of serious adverse events.”

As of June 2022, more than 5.6 million women in the US had used the drug, according to the FDA. During that period, the agency received 4,200 reports of complications in women, or less than a tenth of 1% of women taking the drug.

Associated Press writers Paul Weber in Austin, Texas and Lindsay Whitehurst in Washington contributed to this report.

Justin Scaccy

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