US Court preserves access to abortion drug mifepristone, tightens rules

Austin, Texas: Mifepristone, the medicine used to induce abortions, is still legal to use for the time being, according to a federal appeals court, but the amount of time during which it may be used has been shortened, and it cannot be sent to patients through mail.

The judgement made late on Wednesday temporarily restricted a Texas lower court judge’s finding that had initially prevented the Food and Drug Administration from approving the most popular abortion technique in the country. Even yet, less than a year after the Roe v. Wade decision was overturned and more than a dozen states effectively outlawed abortion, blocking the pill from being supplied by mail amounts to another severe restriction on access to abortion.

The US Supreme Court will probably hear the case.

“We are going to continue to fight in the courts, we believe the law is on our side, and we will prevail,” White House Press Secretary Karine Jean-Pierre said Thursday, speaking to reporters from Dublin during a visit by President Joe Biden.

Opponents that brought the Texas lawsuit against the drug last year cast the decision by the 5th US Circuit Court of Appeals as a victory.

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

Abortion rights groups expressed relief that the FDA approval would remain in place for now but criticized the court for reinstating restrictions on the drug. Whole Woman’s Health, an abortion provider that operates six clinics in five states, said in a tweet they were continuing to offer mifepristone in clinics and through virtual services while reviewing the decision that came down shortly before midnight Wednesday.

In the 2-1 vote, the panel of judges put on hold changes made by the regulator since 2016 that relaxed the rules for prescribing and dispensing mifepristone. Those included extending the period of pregnancy when the drug can be used from seven weeks to 10, and also allowing it to be dispensed by mail, without any need to visit a doctor’s office.

The panel’s decision came just days after the Justice Department swiftly appealed a far-reaching ruling last week out of Texas when a federal judge blocked the FDA’s approval of the pill following a lawsuit by the drug’s opponents. There is virtually no precedent for a lone judge overturning the regulator’s medical decisions.

The lawsuit challenging the drug’s approval was brought by the Alliance Defending Freedom, which also argued for overturning Roe v. Wade and indicated it was content for now in the mifepristone case. Erin Hawley, an attorney for the group, said it had no plans to seek an appeal that might restore the Texas court’s full ruling.

“The 5th Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law,” Hawley said.

The two judges who voted to tighten restrictions, Kurt Engelhardt and Andrew Oldham, are both appointees of former President Donald Trump. The third judge, Catharina Haynes, is an appointee of former President George W. Bush. She said she would have put the lower court ruling on hold entirely, for now, to allow oral arguments in the case.

Either side, or both, could take the case to the Supreme Court. Opponents of the drug could seek to keep the full lower court ruling in effect. The Biden administration, meanwhile, could ask the high court to allow all the FDA changes to remain in place while the case plays out.

Adding to the uncertainty, a separate federal judge in Washington last week ordered the FDA not to do anything that might block mifepristone’s availability in 17 Democrat-led states suing to keep it on the market. The judge, in that case, has not yet responded to the Justice Department seeking additional clarity this week.

The appeals court judges in the majority in Wednesday’s decision noted that the Biden administration and mifepristone’s manufacturer “warn us of significant public consequences” that would result if mifepristone were withdrawn entirely from the market under the lower court ruling.

But the judges suggested FDA changes making mifepristone easier to obtain since 2016 were less consequential than its initial approval of the drug in 2000. It would be “difficult” to argue the changes were “so critical to the public given that the nation operated — and mifepristone was administered to millions of women — without them for sixteen years,” the judges wrote.

When the drug was initially approved in 2000, the FDA limited its use to up to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone, the next to administer the second drug misoprostol and the third to address any complications. It also required a doctor’s supervision and a reporting system for any serious consequences associated with the drug.

If the appeals court’s action stands, those would again be the terms under which mifepristone could be dispensed for now.

Democratic leaders in states where abortion remains legal since the Supreme Court overturned Roe v. Wade last year say they are preparing in case mifepristone becomes restricted.

New York Gov. Kathy Hochul said Tuesday that her state would stockpile 150,000 doses of misoprostol.

The White House also has contingency plans in place, but Jean-Pierre held off on detailing them while legal action continued. Instead, she detailed a proposed new federal rule to limit how law enforcement and state officials collect medical records if they investigate women who flee their home states to seek abortions elsewhere.

Pharmaceutical executives this week also signed a letter that condemned the Texas ruling and warned that FDA approval of other drugs could be at risk if US District Judge Matthew Kacsmaryk’s decision stands.

At the core of the Texas lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks.

Mifepristone has been used by millions of women over the past 23 years. While less drastic than completely overturning the drug’s approval, the latest ruling still represents a stark challenge to the FDA’s authority overseeing how prescription drugs are used in the US The panel overturned multiple decisions made by FDA regulators following years of scientific review.

Common drug side effects with mifepristone include cramping, bleeding, nausea, headache and diarrhoea. In rare cases, women can experience excess bleeding that requires a surgical procedure to stop.

Still, in loosening restrictions on mifepristone, FDA regulators cited “exceedingly low rates of serious adverse events,” with the drug.

More than 5.6 million women in the US had used the drug as of June 2022, according to the FDA. In that period, the agency received 4,200 reports of complications in women or less than one-tenth of 1 per cent of women who took the drug.

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