NEW ORLEANS – Louisiana’s attorney general last month asked a Texas federal court to find the U.S. Food and Drug Administration’s 2023 Risk Evaluation and Mitigation Strategy for an abortion-causing drug “unlawful.”
Murrill
Attorney General Liz Murrill filed a 72-page complaint in the U.S. District Court for the Northern District of Texas, Amarillo Division.
The named defendants are the FDA; Dr. Martin A. Makary, commissioner of Food and Drugs at the FDA; Dr. George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research; the U.S. Department of Health and Human Services; and HHS Secretary Robert F. Kennedy Jr.
Makary supervises the approval of new drug applications, supplemental new drug applications, and the issuance, modification, waiver, suspension, or removal of a REMS. Tidmarsh is tasked with regulating drugs throughout their lifecycle.
Louisiana’s lawsuit takes issue with the REMS’ in-person dispensing requirements for mifepristone. Currently, the medication can be prescribed via telehealth.
According to Murrill’s complaint, mifepristone is a synthetic steroid and endocrine disruptor that blocks progesterone receptors in the uterus. Progesterone is necessary to maintain a pregnancy and support a growing baby. By blocking progesterone receptors, mifepristone causes the uterine lining to deteriorate, starving the baby of oxygen and nutrition and eventually killing the baby.
Mifepristone is typically administered as part of a two-drug regimen involving a second drug called misoprostol. Mifepristone is first introduced, killing the baby. Then misoprostol is introduced, which induces contractions to expel the baby from her mother’s womb.
The overturning of Roe v. Wade in 2022 by Dobbs v. Jackson Women’s Health Organization placed authority over abortion laws with individual states.
Many states have since outlawed abortion, but abortion pills such as mifepristone, which are taken to induce chemical abortions, are being shipped into states illegally, Murrill alleges.
“Shortly after Dobbs, pro-abortion activists and doctors launched a nationwide effort to effectuate abortions in pro-life states like Louisiana – all without setting foot in those states. How? By mail,” Louisiana’s complaint states.
“Every year, doctors and activists in states like California and New York mail a U.S. Food and Drug Administration (FDA)-approved abortion drug called mifepristone to thousands of Louisiana residents for the express purpose of causing abortions in Louisiana that are blatantly unlawful.”
But some of the women who ingest the drugs do not want an abortion, the attorney general argues.
“Since FDA effectively allowed ‘blind’ dispensing without the in-person care of a doctor, bad actors have been able to obtain FDA-approved abortion drugs from prescribers in other states and then secretly spike women’s drinks without their knowledge or force women into taking these drugs against their will,” the complaint states.
Take co-plaintiff Rosalie Markezich, a Louisiana resident, for example.
According to the complaint, Markezich became a victim of the FDA’s mail-order abortion scheme in October 2023 when her boyfriend ordered FDA-approved abortion drugs from a California doctor. She claims she was coerced to take them by her boyfriend. The drugs, she alleges, killed her child.
“This extra-territorial mailing of abortion drugs is illegal under state law – and it is the direct result of the Biden Administration’s 2023 agency action expressly facilitating this scheme,” Louisiana’s complaint states. “That action is the subject of this lawsuit.”
In 2023, the Biden Administration removed the in-person dispensing requirement from its REMS for mifepristone, according to the lawsuit.
“The Biden Administration did so for avowedly political reasons,” Murrill alleges in the complaint. “President Biden had ordered his Administration to ‘identify all ways’ to make abortion available in those states that, after Dobbs, opted to choose life for the unborn.
“And the 2023 REMS was a banner achievement in carrying out that directive for – as FDA freely noted – the 2023 REMS now allows the ‘dispensing of mifepristone through the mail… or through a mail-order pharmacy.’”
Murrill noted in the filing that five Fifth Circuit judges already have recognized that the 2023 REMS is unlawful on Administrative Procedure Act grounds.
The attorney general and Markezich are asking in their filing that the federal court enter an order and judgment against the defendants holding the 2023 REMS unlawful and vacating it; issuing a preliminary and permanent injunction ordering it be withdrawn; and award plaintiffs costs and attorneys’ fees.
Murrill said in a statement this isn’t the first time she has raised concerns about the distribution of abortion-inducing pills.
“It’s dangerous, irresponsible, unethical, and illegal to distribute these pills to strangers in violation of the criminal laws of our State, without any relationship whatsoever to the individual who may ultimately be consuming them,” she said.
“I’ll continue to pursue anyone and use any legal means available to us to hold them accountable. I will enforce and defend the laws of our State, including suing the governors whose shield laws purport to protect these individuals from criminal conduct in Louisiana.”
In July, Murrill joined a coalition of more than a dozen state attorneys general, urging Congressional lawmakers to consider passing federal legislation to preempt pro-abortion states’ shield laws that attempt to protect those who ship such pills to states where abortion is illegal.
