October 28, 2024

Drgreesh

Health Can Do

The Supreme Court Will Soon Decide on Abortion Pill Access

The Supreme Court is facing a self-imposed Friday night deadline to decide whether women’s access to a widely used abortion pill will stay unchanged or be restricted while a legal challenge to its Food and Drug Administration approval goes on.

The justices are weighing arguments that allowing restrictions contained in lower-court rulings to take effect would severely disrupt the availability of the drug, mifepristone, which is used in the most common abortion method in the United States.

It has repeatedly been found to be safe and effective, and has been used by more than 5 million women in the U.S. since the FDA approved it in 2000.

The Supreme Court had initially said it would decide by Wednesday whether the restrictions could take effect while the case continues. A one-sentence order signed by Justice Samuel Alito on Wednesday gave the justices two additional days, without explanation.

The justices are scheduled to meet for a private conference Friday, where they could talk about the issue. The additional time could be part of an effort to craft an order that has broad support among the justices. Or one or more justices might be writing a separate opinion, and asked for a couple of extra days.

The challenge to mifepristone, brought by abortion foes, is the first abortion controversy to reach the nation’s highest court since its conservative majority overturned Roe v. Wade 10 months ago and allowed more than a dozen states to effectively ban abortion outright.

In his majority opinion, Alito said one reason for overturning Roe was to remove federal courts from the abortion fight. “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives,” he wrote.

But even with their court victory, abortion opponents returned to federal court with a new target: medication abortions, which make up more than half of all abortions in the United States.

Women seeking to end their pregnancies in the first 10 weeks without more invasive surgical abortion can take mifepristone, along with misoprostol. The FDA has eased the terms of mifepristone’s use over the years, including allowing it to be sent through the mail in states that allow access.

The abortion opponents filed suit in Texas in November, asserting that FDA’s original approval of mifepristone 23 years ago and subsequent changes were flawed.

They won a ruling on April 7 by U.S. District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, revoking FDA approval of mifepristone. The judge gave the Biden administration and New York-based Danco Laboratories, mifepristone’s maker, a week to appeal and seek to keep his ruling on hold.

Responding to a quick appeal, two more Trump appointees on the 5th U.S. Circuit Court of Appeals said the FDA’s original approval would stand for now. But Judges Andrew Oldham and Kurt Englehardt said most of the rest of Kacsmaryk’s ruling could take effect while the case winds through federal courts.

Their ruling would effectively nullify changes made by the FDA starting in 2016, including extending from seven to 10 weeks of pregnancy when mifepristone can be safely used. The court also said that the drug can’t be mailed or dispensed as a generic and that patients who seek it need to make three in-person visits with a doctor. Women also might be required to take a higher dosage of the drug than the FDA says is necessary.

The administration and Danco have said that chaos will result if those restrictions take effect while the case proceeds. Potentially adding to the confusion, a federal judge in Washington has ordered the FDA to preserve access to mifepristone under the current rules in 17 Democratic-led states and the District of Columbia that filed a separate lawsuit.

The Biden administration has said the rulings conflict and create an untenable situation for the FDA.

And a new legal wrinkle threatens even more complications. GenBioPro, which makes the generic version of mifepristone, filed a lawsuit Wednesday to preemptively block the FDA from removing its drug from the market, in the event that the Supreme Court doesn’t intervene.

For now, the Supreme Court is only being asked to block the lower-court rulings through the end of the legal case. But the administration and Danco have a fallback argument if the court doesn’t agree. They are asking the court to take up the challenge to mifepristone, hear arguments and decide the case by early summer.

The court only rarely takes such a step before at least one appeals court has thoroughly examined the legal issues involved.

The New Orleans-based 5th circuit already has ordered an accelerated schedule for hearing the case, with arguments set for May 17.

 

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