Texas Judge May Use Comstock Law to Stop Mail Delivery

A US judge in Texas might try to invoke a little-known 19th-century law called the Comstock Act to stop mailing mifepristone abortion pills.

Judge Matthew Kachmari of the Northern District of Texas heard oral argument last Wednesday in a closely monitored case in which anti-abortion medical associations challenge the Food and Drug Administration’s approval of mifepristone. At the conclusion of the hearing, Kachmari said the court would issue a ruling and an opinion “as soon as possible.”

The main goal of the Hippocratic Medicine Alliance, the anti-abortion group that filed the lawsuit, is to remove mifepristone from the US market. But Kachmari may not block sales and instead order the FDA to impose tighter restrictions on the distribution of the pills. legal experts.

Its rationale may have depended in part on Comstock’s Law. He repeatedly raised the issue of the 1873 law during last week’s hearings and seemed more sympathetic to the arguments put forward by the lawyers for the Hippocratic Medicine Alliance than to the arguments put forward by government lawyers.

Lawyers for the anti-abortion group argued that the Comstock Act and other laws prohibited mail-order mifepristone. As a consequence, they said the FDA’s 2021 decision to allow patients to receive pills by mail was illegal. Eric Baptist, an attorney representing the Hippocratic Medicine Alliance, said any decision against the FDA must be “universal and nationwide.”

The Biden administration is expected to quickly appeal any decision against the FDA. During a hearing last week, Justice Department lawyer Daniel Schwei asked the judge to suspend any order against the FDA pending a government appeal, or impose an administrative stay of at least 21 days.

According to Rachel Rebush, an expert on reproductive health law at Temple University, the Comstock Act has not been enforced for decades. But Kachmari could have tried to “breathe life into Comstock’s law.” through the decree Rebush said this blocks the FDA’s move to remove the requirement for personal dispensing of mifepristone and allow mail-order delivery of mifepristone. Rebush was one of 19 drug law experts who signed a memo in court in support of the FDA.

Congress passed the Comstock Act in 1873 after anti-vice Anthony Comstock successfully lobbied legislators to declare “obscene” material unmailable. This includes any substance, drug or medication advertised for use in abortion.

Join Healthy Returns on CNBC on March 29, where we’ll convene a virtual meeting of healthcare executives, scientists, investors and innovators to discuss the progress made today in redefining the future of medicine. In addition, we will have an exclusive overview of the best investment opportunities in biopharmaceuticals, medical technology and managed care. Find out more and register today: http://bit.ly/3DUNbRo

These provisions of the Comstock Act went largely unenforced after the Supreme Court established federal abortion rights in Roe v. Wade. But Republican politicians and anti-abortion organizations tried to enforce the 150-year-old law after The Supreme Court overturned Row last year when trying to stop the spread of mifepristone.

“It’s hard to track pills in the mail, it’s easier to get around state abortion bans with them,” Rebusch said. “You can order them from abroad, you can go across the border, there are many ways to mail in medical abortion pills. This is an existential crisis for the anti-abortion movement.”

At least 12 states have banned abortion since Row’s fall, and several states still require patients to receive mifepristone in person. In February, 21 Republican Attorneys General warned Walgreens and CVS against distribution of mifepristone in their states.

Ministry of Justice, in a legal opinion in December, said the Comstock Act does not prohibit mail-order delivery of mifepristone unless the sender intends the recipient to use the pill illegally. The conclusion cites several federal court rulings dating as far back as 1915 that narrowed the scope of the Comstock abortion laws.

But Kachmari insisted to government lawyers what he should do with the Justice Department’s opinion versus a “sufficiently final reading” of the language of the Comstock Act.

The judge appeared to be sympathetic to the 22 Republican attorneys general who filed a memo arguing that the FDA’s handling of mifepristone violated the Comstock Act. He has raised the GOP Attorneys General’s argument several times that the FDA is undermining the ability of states to regulate abortion.

Kachmari did not mention a filing filed by 22 Democratic attorneys general who said the decision against the FDA would jeopardize access to abortion in their states where the procedure is legal.

Kachmari appears to have suggested that the FDA’s actions regarding mifepristone have “changed the field of federal-state relations regarding the regulation of abortion.” He asked Hippocratic Medicine Alliance attorney Erin Hawley to weigh in on the Republican Attorney General’s arguments.

Hawley told the judge that if the Justice Department’s view of the Comstock Act is correct, “you are indeed seeing a sea change in the relationship between the federal center and the states.”

“The Dobbs decision says it leaves the people, the elected representatives, the right to defend life,” Hawley told the judge. She called the Justice Department’s opinion an “insult” to the states, as it deprives them of the right to set health policy within their borders.

Kachmari later asked Justice Department attorney Julie Straus Harris what weight the government places on the Republican attorneys general’s arguments in their memo.

Harris said the FDA’s decision that mifepristone is safe and effective places no obligation on the states or their residents. Rather, the anti-abortion groups that have filed the lawsuit seek to dictate abortion policy that will affect people across the country, she argues.

“But the plaintiffs are the ones who are trying to dictate national policy by asking this court to revoke the agency’s safety and efficiency determination,” Harris told the judge.

The Hippocratic Medicine Alliance asked the judge to overturn all major regulatory actions taken by the FDA on mifepristone, including its approval in 2000. The group is targeting a 2021 FDA decision to allow mail-order pills, as well as a decision to reduce doctor visits and a 2019 approval of generic mifepristone.