At stake in the mifepristone case: Abortion, FDA authority, and a return to the 1873 Obscenity Act.
At stake in the mifepristone case: Abortion, FDA authority, and a return to the 1873 Obscenity Act.

Lawyers for the conservative Christian group that won the case to withdraw Roe v. Wade are returning to the U.S. Supreme Court on Tuesday in pursuit of an urgent priority: shutting down access to the abortion pill for women across the country.

The case challenges the FDA’s regulation of mifepristone, a prescription-only drug approved in 2000 with a stellar safety record that is used in 63 percent of all U.S. abortions.

Seen through decades of anti-abortion activism, the lawsuit filed by the Alliance for the Defense of Liberty is a “moonshot” couched in technical arguments over pharmaceutical oversight and the revival of an 1873 obscenity law. A victory would set the stage for a de facto national abortion ban.

Abortion is illegal in 14 states, but abortion pills have never been more widely available.

During the covid-19 pandemic, the FDA suspended — and later formally rescinded — the requirement that patients be in a health care facility when taking mifepristone, the first of two pills used in medical abortion. Doctors can now prescribe the drug online via telemedicine, and pharmacies can dispense it by mail.

“You don’t need to be handed the pill in the office,” said Linda Prine, a family medicine physician, sitting on the couch in her Manhattan apartment answering texts and calls from patients about abortion care.

“It’s very efficient,” she said. “I don’t even have drugs that are 98 to 99 percent effective. Our blood pressure medications are not as effective.

Prine, co-founder of the Miscarriage and Abortion Hotline, works with other doctors working under New York State’s shield law to prescribe and ship abortion pills to people across the country. A review of Prine’s call log, stripped of personal information, showed hundreds of pill requests from Texas, Louisiana, Tennessee and other states where it is illegal for women to terminate pregnancies.

Anti-abortion groups have unsuccessfully petitioned the FDA at least twice before, in 2002 and 2019, to revoke mifepristone’s approval and limit its availability. But in November 2022, after its victory in overturning federal abortion rights, the Alliance Defending Freedom filed a federal lawsuit in Amarillo, Texas, alleging that the FDA’s safety review of mifepristone was flawed.

U.S. District Judge Matthew Kaczmarik, who was appointed by President Donald Trump and openly opposes abortion, ruled to void the FDA’s approval of mifepristone. An appeals court later said the drug should remain available but reinstated restrictions, including bans on telehealth prescriptions and sending the drug by mail. That decision was put on hold while the Supreme Court heard the case.

The Biden administration and the maker of mifepristone, Danco Laboratories, have argued in court filings with the Supreme Court that federal judges lack the scientific and health expertise to evaluate the drugs’ safety and that allowing them to do so undermines the FDA’s regulatory authority.

That view is supported by food and drug legal scholars, who write in court filings that lower courts have substituted “the FDA’s scientific and medical expertise for the courts’ own interpretations of the scientific evidence.” In doing so, they write, the courts are “overturning the drug regulatory scheme created by Congress and enforced by the FDA.”

In his decision, Kacsmaryk cited two studies that allegedly showed an increase in emergency room visits and a greater risk of hospitalizations due to medical abortion. They were withdrawn in February by medical publisher Sage Perspectives. The journal said the researchers erred in their methodology and data analysis and invalidated the papers “in whole or in part.”

The study, backed by the Charlotte Lozier Institute, an anti-abortion group that filed a complaint in the mifepristone case, “made claims that were not supported by the data,” said Ushma Upadhyay, a professor of reproductive sciences at the University of California-San Francisco.

Legal scholars say conservative Supreme Court justices have shown a willingness to accept discredited health claims related to abortion. Justice Samuel Alito wrote the majority opinion Dobbs v. Jackson Women’s Health Orgwhich overturned the constitutional right to abortion, cited claims of harm to maternal health presented by the state of Mississippi that contradicted the mainstream medical consensus.

“If this case is successful, it will be because the Supreme Court chose to ignore evidence that demonstrated the safety of mifepristone and told a federal agency, an expert on drug safety, ‘You were wrong,'” said Rachel Rebusche, dean of Temple University Beasley School of Law.

The mifepristone case crystallized the “politicization of science” in abortion regulation, Rebusche said. “But the stakes are getting higher as we have courts willing to strip federal agencies of their ability to make expert decisions.”

Rebuscher said that if the Supreme Court overturns the FDA’s expertise in regulating a 24-year-old drug like mifepristone, anti-abortion groups such as Students for Life of America could find the justices receptive to false claims that birth control pills, intrauterine devices, emergency contraception and other forms of hormonal birth control cause abortion. They don’t, according to reproductive scientists and US and international regulatory agencies.

Justice Clarence Thomas wrote in his concurring opinion in Dobbs that the Supreme Court should review the 1965 decision that guaranteed a constitutional right to contraception, Griswold v. Connecticutand decide whether to return the power to authorize or regulate access to birth control to the states.

In the files of the Alliance for the Defense of Freedom is what scholars describe as a bold legal strategy once on the fringes of the conservative Christian movement: an appeal to conservative members of the Supreme Court to find that the Comstock Act, a dormant law against the vices of 1873, effectively banned medical and procedural abortion nationwide.

It came out at a time when the federal government did not give women the right to vote and the prevailing medical literature summed up female sexuality by saying that “the majority of women (fortunately for them) are not very troubled by sexual feelings of any kind ,” the law, which was long unenforced, provided for a sentence of five years in prison for anyone who mailed “any article, instrument, substance, drug, medicine, or thing advertised or described in a manner calculated to induce others to use or apply it to effect an abortion.”

References to the Comstock Act appear in court documents and anti-abortion rulings: Kacsmaryk writes that the act “clearly prohibits abortions by mail in the present”; The 5th Circuit Court of Appeals wrote that if Comstock was “strictly understood,” then “there is no public interest in perpetuating illegality”; Republican attorneys general threatened legal action against Walgreens and CVS last year, citing Comstock as well as anti-abortion cases in New Mexico and Texas.

State attorneys general should pursue and prosecute those who illegally ship abortion drugs into their state,” said Kristan Hawkins, president of Students for Life in America.

“It’s very simple. If your state has passed a law saying that unborn human beings deserve at least the right not to be starved and killed, then those who commit these crimes and violate the federal Comstock Act by shipping chemical abortion pills across state lines should to have consequences.

Tracking abortion pills in the mail is difficult — and that’s the point, Rebusche said.

“These more dispersed and mobile ways of terminating a pregnancy,” she said, “really threaten the control that anti-abortion advocates seek to exert over who, where and how someone can request an abortion.”

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