In abortion pill hearing, Supreme Court sounds skeptical of challenge to mifepristone access

It's the first major abortion rights case since Roe was overruled.

A high-stakes hearing played out before the U.S. Supreme Court on Tuesday in a case that could reshape abortion access nationwide.

The justices considered a challenge to the Food and Drug Administration’s regulation of mifepristone, the first pill taken in a two-drug regimen for a medication abortion, which is the most common method of abortion in the country.

It is the first major reproductive rights case before the high court since Roe v. Wade was overturned in 2022. A decision is expected by the end of June.


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Government says anti-abortion doctors still have individual 'conscience protections'

Amid questions from the Supreme Court about who has standing to sue, Solicitor General Elizabeth Prelogar said the federal government believes individual doctors still have broad "conscience protections" if they oppose abortion and decline to provide such access in specific instances.

Prelogar reaffirmed that later in the hearing when some justices returned to the topic but noted that the government believes there are exceptions under the law.

Preolgar previously argued that the government does not believe states have standing in this case to sue.


Solicitor general argues supposed harm is 'unduly speculative'

Solicitor General Elizabeth Prelogar is arguing the supposed harm cited by the anti-abortion alliance is "unduly speculative" and hypothetical.

"Their theories rest on a long chain of remote contingencies," she said. "Only an exceptionally small number of women suffer the kind of serious complications that could trigger any need for emergency treatment. It's speculative that any of those woman would seek care from the two specific doctors who asserted conscience injuries."

Prelogar also asserted that if there were any safety consequences to a drug, the FDA could take action itself to fix it.


Justices ask if anyone has standing to sue FDA over mifepristone

Justice Clarence Thomas asked Solicitor General Elizabeth Prelogar if there is anyone who would have have a legal right to sue in this case -- which quickly emerged as the first major topic of the court's questioning of the federal government. The FDA has claimed the current plaintiffs do not have standing, with Prelogar suggesting at the hearing that their relationship to people who use mifepristone is too speculative and remote.

Prelogar said there may be an instance where a "competing drug manufacturer might sue and claim that FDA approval of a drug creates a competitive harm or injury or injury in that sense."

Chief Justice John Roberts asked if there is a number of adverse events or a number of patients who go to the emergency room in which the arguments would change. Facing such questions, Prelogar responded by reiterating her view that these possibilities appeared to be too theoretical and detached from specific decision-making and the history of patients who have used mifepristone.


Government defends FDA's expert judgments and warns of 'grave harm' for women

Pelogar, in her opening statement, contended the anti-abortion plaintiffs have no standing and defended the FDA's approval of the drug.

She warned that the relief sought by the Alliance for Hippocratic Medicine would both "severely disrupt the federal system for developing and approving drugs" and "inflict grave harm on women across the nation."


What anti-abortion groups claim about mifepristone

The lead plaintiff, the Alliance for Hippocratic Medicine, had initially challenged the FDA’s approval of mifepristone.

But the matter before the high court now is more narrow -- whether the FDA's subsequent regulatory decisions about the drug, in 2016 and 2021, were sound.

In court filings, the Alliance Defending Freedom, a Christian conservative legal advocacy representing the plaintiffs, has claimed mifepristone is not safe and that the FDA didn't study it closely enough before it was approved.

The group also argued that the FDA’s decisions in 2016, lowering the recommended dosage and extending the use from seven weeks through 10 weeks of pregnancy, and in 2021, which permanently lifted the restriction on requiring abortion pills to be dispensed in-person, were unsound.

In January 2022, the FDA went further by allowing retail pharmacies to provide the drug too, either by mail or in person, so long as they meet certain requirements, which the plaintiffs claim violate federal laws that prohibit the distribution of chemical abortion drugs by mail.

The FDA rejects the claims, arguing that mifepristone is safe when used as indicated and directed, and that the pill went through a thorough and comprehensive review before being approved.