Appeals court appears likely to restrict access to key abortion pill
A panel of judges aggressively questioned lawyers for the Justice Department and for the manufacturer of mifepristone about FDA regulations that made the drug more accessible over time.
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NEW ORLEANS — A federal appeals court on Wednesday seemed prepared to limit access to a key abortion medication first approved more than two decades ago, expressing deep skepticism that the government followed the proper process when it loosened regulations to make the pill more readily available.
A panel of three judges, all of whom have previously supported other types of abortion restrictions, peppered lawyers for the government and the drug manufacturer with questions about why the Food and Drug Administration has allowed mifepristone to be prescribed by a medical professional other than a doctor and sent directly to patients by mail.
The judges also appeared to embrace the suggestion that restoring prior restrictions on mifepristone would mean fewer women would need emergency care after using medication to terminate a pregnancy. Serious side effects occur in less than 1% of such abortions.
Judge James C. Ho rejected the government’s argument that the court should not second-guess the expertise of the FDA, which first approved the mifepristone in 2000. The medication is part of a two-drug regimen used in more than half of U.S. abortions.
“I don’t understand this idea that FDA can do no wrong,” Ho said. “We are allowed to look at FDA just like any other agency.”
Judge Jennifer Elrod took the unusual step of chastising the drug company’s lawyer for the pointed language used in court filings to criticize a lower court ruling in April that would outright suspend FDA approval of the drug.
The legal battle over abortion has shifted to a fast-moving fight over access to mifepristone in the months since the Supreme Court overturned Roe v. Wade’s constitutional right to abortion, and as multiple states have moved to limit and ban the procedure. Lawmakers in North Carolina voted this week to significantly narrow the window for legal abortions in the state, with more restrictions expected to pass in Nebraska and South Carolina in the coming days.
The conservative U.S. Court of Appeals for the 5th Circuit was reviewing whether the Food and Drug Administration properly approved the pill, which can be mailed to patients and taken at home.
Regardless of how the three-judge panel rules in the weeks or months following Wednesday’s two-hour hearing, mifepristone will remain available under existing regulations until the case is resolved likely by the Supreme Court.
Antiabortion advocates behind the lawsuit said in court filings that the FDA improperly cleared the medication for use in 2000, then later removed safeguards to make the pill more widely available and allowed the drug to be mailed in violation of federal law.
“These actions do not reflect ‘scientific’ judgment but politically driven decisions to unlawfully push a dangerous regimen,” wrote lawyers for the Christian conservative group, Alliance Defending Freedom, led by attorney Erin M. Hawley.
The Justice Department, representing the FDA, and the drug manufacturer Danco Laboratories, told the court that the pill has been safely used by more than five million women to terminate their pregnancies. Revoking approval after more than two decades, they said, would jeopardize access to other non-abortion drugs and more broadly impact medical research and innovation.
Courts should not “second guess FDA’s scientific judgments about the safety of a drug based on anecdotal allegations, speculative harm and flawed studies,” government lawyers said in its filings. “FDA relied on dozens of studies involving tens of thousands of women, to support its conclusions that mifepristone is safe and effective under the approved conditions of use.”
The three judges randomly assigned to hear the case Wednesday are Judges Ho and Cory T. Wilson — both nominated by President Donald Trump — and Elrod, a nominee of President George W. Bush.
The lawsuit was brought by the Alliance for Hippocratic Medicine, an association of antiabortion doctors and others, and filed in Amarillo, where U.S. District Judge Matthew Kacsmaryk — a Trump nominee with long-held antiabortion views — is the sole sitting judge.
In April, Kacsmaryk took the unprecedented step of suspending the FDA’s approval of the mifepristone, which is used as part of a two-drug regimen to terminate a pregnancy. The second drug, misoprostol, can also be used on its own to terminate early pregnancies, but the two drugs in tandem reduce cramping and bleeding.
Kacsmaryk agreed with the plaintiffs’ claims that the FDA did not sufficiently consider safety concerns. His language echoed terminology used by antiabortion activists, referring to abortion providers as “abortionists” and to fetuses and embryos as “unborn humans.”
In an initial review of Kacsmaryk’s ruling, a separate three-judge panel of the 5th Circuit declined to suspend approval of mifepristone but reversed actions taken by the FDA since 2016 to loosen restrictions on how to access the medication. The agency extended the drug’s approved use through 10 weeks of pregnancy instead of seven, allowed medical professionals other than doctors to write prescriptions and allowed patients to receive the drug through the mail.
The Supreme Court blocked that appeals court action in April, opting to leave the current FDA regulations for mifepristone in place while the litigation continues.
Lawyers for the Justice Department and drug manufacturer told the court in advance of Wednesday’s hearing that the challengers had no legal right — or standing — to file the lawsuit because they were not directly harmed by the FDA’s approval of the abortion pill. The challengers’ safety concerns were based on flawed studies, the lawyers said.
The antiabortion doctors “do not prescribe mifepristone. They do not provide abortions. No specific doctor faces irreparable harm” because their claims “rest on cascading chains of speculation about potential future events,” Danco’s lawyer Jessica Ellsworth told the court.
In response, the individual doctors and antiabortion associations behind the lawsuit said they are directly affected when they are forced to care for patients who require additional treatment in the small percentage of cases in which the medication abortions are not successful.
Separately, the challengers object to the Biden administration’s decision in 2021 to allow the abortion pill to be mailed directly to patients. Shipping abortion medication, they say, violates a 150-year-old law that most legal experts considered obsolete.
The Comstock Act prohibits the mailing of any drug “intended for producing abortion.” The Biden administration has rejected that interpretation as outdated, and asserted in a recent legal memo that mailing the pill is permitted when the sender believes the drug will be used lawfully in states where abortion is permitted.
Allowing the pill to be sent by mail, has made it more difficult for states to enforce abortion bans passed after the Supreme Court overturned Roe.
The justices returned to “the people the power to protect women’s health, unborn life, and the integrity of the medical profession by regulating abortion," Hawley, the group’s lawyer, told the court. “Yet, the considered judgments of states that have chosen to do so are rendered meaningless by FDA’s mail-order abortion scheme.”
Officials from nearly two dozen states led by Democrats warned the 5th Circuit in court filings that applying the Comstock Act to mifepristone would have “potentially boundless effects on medical care delivery” by preventing the distribution of devices, surgical instruments and equipment used in obstetrics and gynecology, in addition to drugs routinely used in other medical treatments.
The cases are FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine.
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