Future of key abortion pill mifepristone in the hands of federal appeals court

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Illustration by Alex Cochran for Yahoo News; photos: Getty Images.
Illustration by Alex Cochran for Yahoo News; photos: Getty Images.

What’s happening

A federal appeals court in Louisiana heard arguments Wednesday in a high-stakes legal battle over women's access to a widely used key medication abortion drug.

Mifepristone is often paired with a second drug, misoprostol, to end a pregnancy and accounts for about half of all abortions in the U.S. The drug can also be used in the treatment of miscarriages.

The case concerns the Food and Drug Administration’s approval of mifepristone in 2000 and the agency’s subsequent actions making the drug more accessible, such as increasing the gestational limit from seven to 10 weeks and allowing the drug to be prescribed through telehealth visits and sent through the mail.

The Alliance for Hippocratic Medicine, a coalition of abortion opponents, sued the FDA last November in federal court, challenging the agency’s decades-old approval of mifepristone. The lawsuit was filed in the U.S. District Court for the Northern District of Texas, Amarillo Division, where U.S. District Judge Matthew Kacsmaryk, who was appointed by former President Donald Trump, is the only presiding judge.

In April, Kacsmaryk sided with the plaintiffs and ruled that the FDA’s approval of mifepristone and the subsequent decisions to make the drug more accessible were improper under its authority.

In response to Kacsmaryk’s decision, the Biden administration filed its notice of appeal to the U.S. Court of Appeals for the Fifth Circuit in New Orleans. The appeals court disagreed in part with Kacsmaryk’s ruling, finding that the statute of limitations had passed on the plaintiff’s ability to challenge the FDA’s approval of mifepristone, but blocked the implementation of the changes made in 2016 and after regarding easier access to the medication.

The Justice Department and the manufacturer of mifepristone, Danco Laboratories, then asked the Supreme Court to freeze the Fifth Circuit’s decision and preserve the status quo. On April 21, the Supreme Court halted restrictions imposed by the lower courts while litigation continues to play out.

This brings us to the May 17 appellate hearing. The three conservative judges in the U.S. 5th Circuit Court of Appeals, who have a history of supporting abortion restrictions, grilled attorneys from the Biden administration and Danco, the drug's manufacturer, and appeared skeptical of their arguments to preserve access to mifepristone.

Why there’s debate

Most Americans (51%) say the Supreme Court “should prevent any changes” to the accessibility of mifepristone “by reversing the Texas ruling,” according to a recent Yahoo News/YouGov poll. On the flip side, just 22% of Americans think “the Supreme Court should outlaw mifepristone in all 50 states by upholding the Texas ruling.”

The potential rollback of the FDA’s approval of mifepristone could have far-reaching implications. Not only could it upend the lives of millions of women in the United States, but medical experts and pharmaceutical companies have voiced concern that such a decision could set a precedent allowing legal challenges to bombard drugmakers and discourage them from bringing potentially lifesaving drugs to market.

Twenty-three Democrat-run states and the District of Columbia, along with hundreds of Democratic lawmakers, have filed amicus briefs to the Supreme Court in support of the Biden administration’s efforts to preserve the FDA’s approval of mifepristone.

"Decades after FDA's initial approval — yet somehow in an emergency posture — the district court intruded into FDA's drug approval process, casting a shadow of uncertainty over its decisions," a group of Congressional Democrats wrote in a brief to the Supreme Court. "The perils of this unwarranted judicial intervention into science-based determinations can hardly be overstated."

Meanwhile, 21 red states and 147 Republican lawmakers have urged the Supreme Court to allow the Fifth Circuit’s ruling to take effect, which would reinstate restrictions on access to mifepristone. In an amicus brief to the high court, GOP members of Congress wrote: “By approving and then deregulating chemical abortion drugs, the FDA failed to follow Congress' statutorily prescribed drug approval process and subverted Congress' critical public policy interests in upholding patient welfare."

Mifepristone has been used by more than 5 million women and is considered safe and effective for abortions and miscarriage care by the U.S. Department of Health and Human Services, the American Medical Association (AMA) and the American College of Obstetricians and Gynecologists. According to the AMA, major adverse reactions to mifepristone occur in about 0.3% of cases and are “exceedingly rare.”

What’s next

The judges likely won’t rule immediately after Wednesday’s hearing. But when the court does make a decision, whichever side loses the appeal could petition for a rehearing by the full Fifth Circuit, which has 12 Republican appointees out of a total of 16 active judges, and petition the U.S. Supreme Court for a second time.

Access to mifepristone would remain widely available if the Supreme Court accepts the case for review. If not, the decision by the Fifth Circuit will be the final word on the fate of mifepristone.


Decisions on drug approvals and abortion shouldn’t be left up to the courts

“The Justices in Dobbs sought to extricate themselves from regulating abortion, but partisans on both sides don’t want to let them. The partisans don’t appreciate that the stakes in these two cases go beyond abortion. If pro-life groups or Democratic AGs prevail, we’ll likely see more partisan challenges to FDA approvals, such as for Covid vaccines or Alzheimer’s treatments. Regulating drugs isn’t the business of the courts any more than abortion is.” — Editorial, Wall Street Journal

Plaintiffs’ argument is flawed, progressive or not

"If the subject matter of this case were anything other than abortion, the plaintiffs would have no chance of succeeding in the Supreme Court. The plaintiffs are banking on the hope that because this is a case about abortion, the Court will bend ordinary principles of administrative law. I predict it will not.” — Adam Unikowsky, a partner at Jenner & Block law firm who clerked for the late conservative Justice Antonin Scalia, Adam’s Legal Newsletter

Congress has the power to ban mifepristone but hasn’t done so

“The plaintiffs allege that mifepristone is unsafe and the FDA never should have approved it. But mifepristone has been widely used in this country for 23 years. If it is so dangerous, where is the popular political support to ban it outright? Congress doesn’t need permission from the FDA to ban anything. If Congress wants to ban mifepristone, it can.” — Conn Carroll, Washington Examiner

The lawsuit threatens the FDA’s ‘gold standard’ drug approval process

“The doors would be open for all sorts of plaintiffs to assert standing and could really make it very hard for the drug manufacturers who rely on the FDA’s final word on drugs.” — Laurie Sobel, associate director of women’s health policy at the nonprofit Kaiser Family Foundation, to The Hill

Limiting access to abortion medication could impact women in states where abortion is protected

“Many of the restrictions that have been rolled out so far on a state-by-state basis have had little effect in New York, where abortion is legal and additional safeguards have been put into place. But since the federal court ruling affects the mail — and many women have mifepristone shipped to their homes — New Yorkers could soon feel the effects, even as the broader question of access to mifepristone is debated in the courts.” — Michael McAuliff, Dave Goldiner, Josephine Stratman, New York Daily News

Keep an eye out for lawsuits in North Carolina and West Virginia that could impact the Texas lawsuit

“Both cases are pressing the argument that the FDA was given the authority by Congress to create a uniform drug policy for this country and is the agency trusted with assessing drugs' safety and efficacy … So FDA regulations should preempt, or is superior, to any state regulation that contradicts it." — Rachel Rebouché, dean of Temple University's law school, to USA Today

Without mifepristone, abortion clinics will be forced to rely on a less effective alternative

“If mifepristone is no longer available at some point, most abortion clinics plan to use misoprostol alone to terminate pregnancies. Studies have shown that misoprostol's success rates can range from 84% to 96%, whereas the two-drug combo can be up to 99.6% effective.” — Lawrence Hurley and Berkeley Lovelace Jr. and Erik Ortiz and Aria Bendix, NBC News

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