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At Stake in Mifepristone Case: Abortion, FDA鈥檚 Authority, and Return to 1873 Obscenity Law

At Stake in Mifepristone Case: Abortion, FDA鈥檚 Authority, and Return to 1873 Obscenity Law

The Supreme Court will hear arguments on March 26 that could have far-reaching consequences for the accessibility of mifepristone, a medication used in abortion. (Oliver Douliery/AFP via Getty Images)

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

The case challenges the FDA鈥檚 regulation of mifepristone, a prescription-only drug approved in 2000 with a that is used in .

Viewed across decades of anti-abortion activism, the case brought by the Alliance Defending Freedom represents a 鈥渕oonshot鈥 couched in technical arguments about pharmaceutical oversight and the resuscitation of an 1873 anti-obscenity law. A victory would lay the groundwork for a de facto nationwide abortion ban.

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

During the covid-19 pandemic, the FDA suspended 鈥 and later formally lifted 鈥 the requirement that patients be at a health care facility when taking mifepristone, the first of two pills used in medication abortion. Physicians can now prescribe the drug online through telemedicine and pharmacies can dispense it through the mail.

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

鈥淚t’s very effective,鈥 she said. 鈥淚 don’t even have medications that are 98 to 99% effective. Our blood pressure medicines aren’t effective like that.鈥

Prine, a co-founder of the Miscarriage and Abortion Hotline, works with other doctors operating under New York state鈥檚 shield law to prescribe and send abortion pills to people across the country. A review of Prine鈥檚 call log, stripped of personal information, showed hundreds of requests for pills from Texas, Louisiana, Tennessee, and other states where it is illegal for women to stop a pregnancy.

Anti-abortion groups unsuccessfully petitioned the FDA at least twice before, in and , to revoke mifepristone鈥檚 approval and curtail its availability. But in November 2022, following its victory in overturning federal abortion rights, the Alliance Defending Freedom filed a federal lawsuit in Amarillo, Texas, claiming the FDA鈥檚 safety review of mifepristone was flawed.

U.S. District Judge Matthew Kacsmaryk, who was appointed by President Donald Trump and openly opposes abortion, ruled . An appeals court later said the drug should remain available, but it reinstated restrictions, including prohibitions on telehealth prescriptions and mailing the medication. That ruling was put on hold while the Supreme Court considers the case.

The Biden administration and a manufacturer of mifepristone, Danco Laboratories, have argued in legal filings to the Supreme Court that federal judges do not have the scientific and health expertise to evaluate drug safety and that allowing them to do so undermines the FDA鈥檚 regulatory authority.

That view is supported by who wrote in court filings that the lower courts had replaced the 鈥淔DA鈥檚 scientific and medical expertise with the courts鈥 own interpretations of the scientific evidence.鈥 In doing so, they wrote, the courts 鈥渦pend the drug regulatory scheme established by Congress and implemented by FDA.鈥

In his ruling, Kacsmaryk cited two studies purporting to show an increase in emergency room visits and a greater risk of hospitalizations from medication abortion. They were by medical publisher Sage Perspectives. The journal said the researchers erred in their methodology and analysis of the data and invalidated the papers 鈥渋n whole or in part.鈥

The research, supported by the Charlotte Lozier Institute, an anti-abortion group that filed a brief in the mifepristone case, 鈥渕ade claims that were not supported by the data,鈥 said Ushma Upadhyay, a professor of reproductive sciences at the University of California-San Francisco.

Legal scholars say the Supreme Court鈥檚 conservative justices have demonstrated a willingness to accept discredited abortion-related health claims. Justice Samuel Alito, writing the majority opinion in Dobbs v. Jackson Women鈥檚 Health Organization, which overturned the constitutional right to abortion, cited statements presented by the state of Mississippi that contradict mainstream medical consensus.

鈥淚f this case is successful, it will be because the Supreme Court decided to ignore evidence that demonstrated mifepristone鈥檚 safety and said to a federal agency, the expert on drug safety, 鈥榊ou were wrong,鈥欌 said Rachel Rebouch茅, dean of Temple University Beasley School of Law.

The mifepristone case crystallizes 鈥渢he politicization of science鈥 in abortion regulation, Rebouch茅 said. 鈥淏ut the stakes are getting higher as we have courts willing to strip federal agencies of their ability to make expert decisions.鈥

Rebouch茅 said that if the Supreme Court overrides the FDA鈥檚 expertise in regulating a 24-year-old drug like mifepristone, anti-abortion groups, like Students for Life of America, could find judges that birth control pills, intrauterine devices, emergency contraception, and other forms of hormonal birth control cause abortion. They do not, according to reproductive scientists and U.S. and international regulatory agencies.

Justice Clarence Thomas wrote in his in Dobbs that the Supreme Court should reconsider the 1965 decision that guaranteed a constitutional right to contraception, , and decide whether to return the power to allow or regulate access to birth control to the states.

Tucked into the Alliance Defending Freedom鈥檚 filings is what scholars describe as an audacious legal strategy once on the fringes of the conservative Christian movement: an appeal to the Supreme Court鈥檚 conservative members to determine that , a dormant 1873 anti-vice law, effectively bans medical and procedural abortion nationwide.

Passed at a time when the federal government did not give women the right to vote and the summed up women’s sexuality by saying that “the majority of women (happily for them) are not very much troubled with sexual feelings of any kind,鈥 the long unenforced law carried a five-year prison sentence for anyone mailing 鈥渆very article, instrument, substance, drug, medicine or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion.鈥

References to the Comstock Act appear throughout anti-abortion legal filings and rulings: Kacsmaryk wrote that the act 鈥減lainly forecloses mail-order abortion in the present鈥; if Comstock was 鈥渟trictly understood鈥 then 鈥渢here is no public interest in the perpetuation of illegality鈥; Republican attorneys general last year citing Comstock as did anti-abortion cases in New Mexico and .

State attorneys general need to go after and prosecute those who are illegally mailing abortion drugs into their state,鈥 said Kristan Hawkins, president of Students for Life of America.

鈥淚t’s very simple. If your state has passed a law saying that preborn human beings deserve, at the very minimum, the right not to be starved and killed,鈥 she said, 鈥渢hen those who are committing those crimes and violating the federal Comstock Act by shipping chemical abortion pills over state lines, there should be consequences.鈥

Tracking abortion pills by mail is difficult 鈥 and that鈥檚 the point, Rebouch茅 said.

鈥淭hese more diffuse and mobile ways to terminate a pregnancy,鈥 she said, 鈥渞eally threaten the control that anti-abortion advocates seek to exercise over who and where and how someone can seek an abortion.鈥