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A US judge in Texas may try to invoke an obscure 19th-century law called the Comstock Act to quash delivery of the abortion pill mifepristone by mail.
Judge Matthew Kacsmaryk of the U.S. Northern District of Texas heard oral arguments last Wednesday in a closely watched case in which anti-abortion medical associations are challenging the Food and Drug Administration’s approval of mifepristone. At the end of the hearing, Kacsmaryk said the court would issue an order and opinion “as soon as possible.”
A central goal of the Alliance for Hippocratic Medicine, the anti-abortion group that filed the lawsuit, is to get mifepristone off the U.S. market. But Kacsmaryk could stop blocking sales and instead order the FDA to impose tighter restrictions on the pill’s distribution, legal experts say.
His rationale could be based in part on the Comstock Act. During the hearing last week, he repeatedly referred to the 1873 law and appeared more sympathetic to the arguments presented by lawyers for the Hippocratic Medicine Association than to those presented by government lawyers.
Attorneys for the anti-abortion group argued that the Comstock Act and other laws prohibit delivery of mifepristone by mail. They argued that the FDA’s 2021 decision to allow patients to receive pills by mail was consequently illegal. Erik Baptist, an attorney representing the Alliance for Hippocratic Medicine, said any decision against the FDA should be “universal and statewide.”
The Biden administration is expected to quickly appeal any decision against the FDA. During a hearing last week, Justice Department attorney Daniel Schwei asked the judge to suspend any injunction against the FDA pending the government’s appeal or impose an administrative suspension for at least 21 days.
The Comstock Act hasn’t been enforced in decades, said Rachel Rebouche, a reproductive health law expert at Temple University. But Kacsmaryk could try to ‘breathe life into the Comstock Act’ with judgment blocking the FDA’s move to drop the in-person dispensing requirement and allow mifepristone to be delivered by mail, Rebouche said. Rebouche was one of 19 drug law experts who signed a brief to the court in support of the FDA.
Congress passed the Comstock Act in 1873 after Anthony Comstock, who opposed the vice crusade, successfully lobbied lawmakers to declare that “obscene” materials could not be shipped. This included any substance, drug or remedy advertised for use in abortion.
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These provisions in the Comstock Act were largely unenforced after the Supreme Court established federal abortion rights in Roe v. Wade. But Republican politicians and anti-abortion organizations tried to invoke the 150-year-old law under the Supreme Court overturned Roe last year as they try to stop the spread of mifepristone.
“Mail-order pills are difficult to trace, making it easier to evade state abortion bans,” Rebouche said. “You can order them from overseas, you can walk across the border, there are many ways to ship medical abortion pills. This is an existential crisis for the anti-abortion movement.”
At least 12 states have banned abortion since Roe came down, and several states still require patients to get mifepristone in person. In February, 21 Republican attorneys general Walgreens and CVS warned against sending mifepristone to their countries.
Ministry of Justice, in a legal opinion in December, said the Comstock Act does not prohibit sending mifepristone through the mail if the sender does not intend for the recipient to use the pill illegally. The opinion cited several federal court rulings dating back to 1915 that narrowed the scope of the Comstock Act’s abortion provisions.
But Kacsmaryk asked government lawyers what to make of the Justice Department’s opinion versus a “fairly definitive reading” of the Comstock Act’s language.
The judge appeared sympathetic to the 22 Republican attorneys general who filed a lawsuit alleging that the FDA’s actions on mifepristone violated the Comstock Act. He repeatedly cited the argument by Republican attorneys general that the FDA undermines states’ ability to regulate abortion.
Kacsmaryk did not mention a motion filed by 22 Democratic attorneys general who said a ruling against the FDA would threaten access to abortion in their states where the procedure is legal.
Kacsmaryk appeared to suggest that the FDA’s actions on mifepristone “changed the landscape of the relationship between the federal state and abortion regulation.” He asked Hippocratic Medicine Association attorney Erin Hawley to weigh in on the Republican attorneys general’s arguments.
Hawley told the judge that if the Justice Department’s opinion on the Comstock Act is correct, “you’re really seeing big changes in federal-state relations.”
“The Dobbs decision said it gave the people, the elected representatives, the power to protect life,” Hawley told the judge. She described the Justice Department’s opinion as an “insult” to states because it denies them the power to set health policy within their borders.
Kacsmaryk later asked Justice Department Rep. Julie Straus Harris what weight the government was giving to the Republican attorneys general’s arguments in their letter to the court.
Harris said the FDA’s determination that mifepristone is safe and effective does not impose any obligations on states or their residents. Instead, the anti-abortion groups that filed the lawsuit want to dictate abortion policy that would affect people across the country, she argued.
“But it is the plaintiffs who are trying to dictate national policy by asking this court to reverse the agency’s determination of safety and efficacy,” Harris told the judge.
The Hippocratic Medicine Association has asked the judge to overturn all major regulatory actions the FDA has taken on mifepristone, including its approval in 2000. The group is targeting the FDA’s 2021 decision to allow the pill to be delivered by mail, as well as the 2016 decision to reduce doctor visits and the approval of a generic version of mifepristone in 2019.
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