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.
Key moments:
Case marks 'only time' a court has limited FDA-approved drug: Prelogar
Justice Elena Kagan pressed Solicitor General Elizabeth Prelogar on the "arresting" statement from the government that this case marks the first time any court has restricted access to an FDA-approved drug.
"That is still to our knowledge the only time a court has done that," Prelogar responded.
"We have seen a disturbing trend of courts sometimes also overriding FDA's judgment to try to grant greater access to drugs and that overrides FDA expert judgment about what's necessary to ensure safe use," she continued. "And no matter which direction you come at it from we, on behalf of FDA, think that courts have no business making those judgments."
Preolgar suggests plaintiffs want reversal due to personal views
Solicitor General Elizabeth Prelogar suggested that the anti-abortion plaintiffs were seeking a sweeping ruling to reverse the FDA's approval of the abortion medication mifepristone because of their personal conscience views.
Prelogar was agreeing with Justice Ketanji Brown Jackson, who raised that idea as she called it a "mismatch" between the issues brought by the plaintiffs and what they are asking the court.
"The obvious common sense remedy would be to provide them with an exemption that they do not have to participate in this procedure and you say federal law already gives them that," Jackson said.
Prelogar says increased ER visits for mail-order pills doesn't mean more adverse effects
Justice Samuel Alito said the plaintiffs argued in court filings that studies have shown after the 2021 change from the FDA that allowed mifepristone to be mailed that there was an increase in emergency room visits.
He asked Solicitor General Elizabeth Prelogar if the FDA's response -- that there were not increases in side effects from the drug -- was proper.
Preolgar said this was a reasoned explanation from the FDA and the agency acknowledged that while some studies have shown the availability of abortion pills by mail led to more ER visits, this did not equate to "more serious adverse effects."
"Many might go because they are experiencing heavy bleeding which mimics a miscarriage and they need to know whether or not they are having a complication," she said.
Alito mentions the Comstock Act: What is it
Being cited in the arguments is the Comstock Act, a 151-year-old law under which it's illegal to use carriers such as the United States Postal Service to mail "obscene" materials such as drugs that induce abortions.
The Alliance for Hippocratic Medicine has said the FDA's decision to allow patients to receive mifepristone by mail instead of in person from certified health providers specifically violates the Comstock Act.
Solicitor General Elizabeth Prelogar, pressed by Justice Samuel Alito on why the FDA didn't consider the application of the Comstock provisions, said she did not think it fell under the FDA's "lane."
"And we don't think it means what respondents suggested," Prelogar said of the law.
Read more about the Comstock Act here.
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.