Louisiana AG faces FDA and abortion pill manufacturers in court

The State of Louisiana faced off against the Food and Drug Administration (FDA) in a US District Court this week over mail-order access to the abortion pill. The State is seeking a preliminary injunction against the FDA's 2023 REMS safety protocol changes, which included the removal of in-person dispensing requirements for the abortion pill mifepristone (200mg).

Key Takeaways:

• Louisiana is seeking an injunction on the 2023 REMS safety rule changes that allowed the abortion pill mifepristone to be dispensed through the mail and sold in pharmacies.

• The State argues that allowing the abortion pill to be dispensed via the mail violates the Comstock Act, causes sovereign harm by facilitating illegal abortions, and causes economic harm by increasing Louisiana's Medicaid costs.

• The FDA claimed that Louisiana's lawsuit will "short circuit" its ongoing review of mifepristone.

• The judge did not indicate when he would issue his ruling, but did give FDA attorneys seven days to file a brief on what emergency action it would take if it found mifepristone to be a public health risk.

The Backstory:

The case, State of Louisiana v. Food and Drug Administration (FDA), et al. was heard Tuesday in federal court before U.S. District Judge David Joseph. Rosalie Markezich, a Louisiana woman who says her ex-boyfriend coerced her into taking abortion drugs, is also listed as a plaintiff in the lawsuit.  

The lawsuit challenges the 2023 REMS, a safety program under which the drug mifepristone (Mifeprex) was placed by the FDA, enabling the drug to be shipped by mail and dispensed in pharmacies.

Louisiana contends that the drug's 2023 REMS (safety regulations):

• Are arbitrary and capricious

• Violate the Comstock Act

• Cause Plaintiffs’ Current and Future Injuries in Fact

• Cause sovereign harm by facilitating illegal abortions in Louisiana.

• Cause economic harm by directly increasing Louisiana’s Medicaid costs.

Earlier this month, 21 states filed an amici curiae brief in support of Louisiana. An additional brief was filed by 60 lawmakers in support of the state.

Danco Laboratories and GenBioPro, the manufacturers of mifepristone, along with the FDA, oppose an injunction for different reasons. They claimed in separate filings that there is no scientific evidence that supports reversing the FDA's 2023 decision allowing the abortion pill to be mailed.

The Details:

Before the hearing, Louisiana's Attorney General, Liz Murrill, posted on X, "Louisiana Chooses Life Today, we are in federal court in Lafayette for a hearing on our lawsuit against the @US_FDA, seeking to vacate a Biden-era rule that removed the longstanding in-person dispensing requirement for the chemical abortion drug mifepristone."

'Merchants of death' that 'profit off babies'

In a press conference following Tuesday's hearing, Murrill referred to Danco and GenBioPro as the "merchants of death" who had come to Louisiana to "argue that they should be able to continue to profit off the distribution of these pills illegally in our state."

"GenBioPro is a generic mifepristone manufacturer, and the sale of mifepristone represents the majority of its total revenue," GenBioPro said in its motion, citing financial harms to its business if the REMS rule is enjoined. It said:

When FDA removed the in-person dispensing requirement in the 2023 REMS, GenBioPro redesigned its supply chain to meet pharmacy demand including through new pharmacy-specific distributor contracts, and by redesigning its logistics framework to incorporate pharmacy distribution. Pharmacy sales now represent a substantial portion of GenBioPro’s total sales.

...There is no doubt that suspending the 2023 REMS would cause immediate and irreparable harm to GenBioPro. Mifepristone accounts for the majority of the company’s revenue, and sales through pharmacy distribution that would be cut off by a stay are a substantial portion of that revenue.

...Compliance with any such regulatory regime would fundamentally disrupt the company’s compliance and distribution framework, requiring significant time and expense to unwind the very distribution network that GenBioPro created in reliance on the 2023 REMS.

Meanwhile, Murrill described a "dramatic uptick of abortions" in Louisiana following the REMS changes, noting that "pills [are] coming through states like California and New York who are intentionally trying to nullify our laws."

“We think that this rule is directly causing some of the harms to our state and facilitating the illegal distribution of pills here—and it’s harming women and it’s killing babies,” Murrill said. She added:

There was absolutely no reason why the FDA should have ever removed that requirement [for in-person abortion pill dispensing]. They did it expressly to facilitate the distribution of these drugs because they wanted to allow other states and doctors and other providers who did not agree with our legal policies to be able to nullify our laws and send those pills here illegally.

READ: Louisiana AG: NY doctor again mailed abortion pill, killing a baby at 20 weeks

'Dangerous,' 'unethical,' 'illegal,' 'immoral.'

Murrill called the removal of in-person dispensing a "very dangerous action that imposed great danger to women and certainly to the babies that we've been trying to protect under our state laws in Louisiana." Mailing the abortion drugs allows for limited-to-no medical oversight of abortion drugs, which are mailed to women who have not seen a doctor to check for contraindications and gestational age (and sometimes to men who have coercive motives).

Murrill also pointed to the dangers of the abortion pill, which has a black box warning for serious infection, hemorrhage, and even sepsis. As Louisiana wrote in its most recent legal response (emphasis added):

We know—and neither FDA nor the manufacturers dispute—that Louisiana already has spent over $90,000 in Medicaid dollars for emergency room care and hospitalizations directly traceable to just two FDA-approved mifepristone-induced abortions.

"It's dangerous, it's unethical, it's illegal, and it's immoral, and I think the FDA is continuing to facilitate that conduct by not reinstating the in-person dispensing requirement," said Murrill.

Danco, the original manufacturer of the drug when it was approved in 2000 by the FDA, downplayed the injuries cited by the State of Louisiana, writing in its motion:

Louisiana claims the 2023 REMS makes it harder for the state to enforce its state-law abortion restrictions, leading to “sovereign,” “quasi-sovereign,” and financial injuries. The first two injuries, as alleged, are not “‘legally and judicially cognizable.’”

GenBioPro argued in its motion that "27% of all abortions nationwide were provided via telehealth, constituting a significant portion of the abortion services in states where abortion is more broadly permitted than it is in Louisiana."

Regarding safety, GenBioPro wrote:

Based on FAERS data and adverse event data submitted by Danco and GenBioPro, FDA determined there were “no new safety concerns” related to the removal of the in-person dispensing requirement, and concluded “there does not appear to be a difference in adverse events between [those] periods”—which “suggests that mifepristone may be safely used without an in-person dispensing requirement.”

...Plaintiffs do not identify any evidence—no clinical trials, adverse event reports, postapproval studies, peer-reviewed literature, or other scientific data—that FDA erred in not considering.

However, as Live Action News has documented and Live Action's detailed report shows, Big Abortion enacted a scheme dating back before the 2016 erosions of the REMS, which removed the requirement to report adverse events other than death. The abortion industry has advised women to lie, claim a natural miscarriage, and bypass required reporting agencies and instead present directly to emergency departments when experiencing a potential concern or complication related to the abortion pill, thereby skewing the data on safety.

Murrill also pointed out that abortion pills were flooding into her state based on "shield laws" aimed at protecting abortionists, and the drugs have been used to coercively force abortions on unsuspecting women. The State, which now lists the drug as a controlled substance, has filed charges against abortion committing physicians in California and New York .

FDA review will take 'indefinite amount of time'

Trump's FDA, which recently approved the second generic abortion pill, claimed Louisiana's lawsuit would "short circuit the [FDA]’s orderly review and study of the safety risks of mifepristone." It asked the courts to "stay judicial review" until the FDA completes its own review of the drug, which it claimed could be completed in less than a year.

But according to the Louisiana Illuminator, "Markezich’s attorney, Erin Hawley with Alliance Defending Freedom, argued in court Tuesday that the FDA’s mifepristone review could take an 'indefinite amount of time' and that’s why the court injunction is necessary."

"Noah Katzen, the FDA’s attorney, stressed multiple times in his arguments that Louisiana’s attempt at 'judicial intervention' would disrupt the agency’s well-established drug review process. But he declined to provide a specific answer when Joseph pressed him for a firm timeline on when the review would be complete," the media outlet added.

In addition, according to the Louisiana Illuminator, Jessica Ellsworth, representing Danco, challenged a claim from Benjamin Aguiñaga, Louisiana’s solicitor general, who said the FDA cleared mifepristone for telehealth use in 2023 in response to the Supreme Court overturning Roe v. Wade in its 2022 Dobbs v. Jackson Women's Health Organization ruling. Ellworth argued the FDA had started the process of changing the rules on dispensing mifepristone two years earlier, to which Aguiñaga responded that the Biden administration was the one to begin that process in 2021, just days after oral arguments were heard in the Dobbs case, and "it became clear where justices would land."

The Bottom Line:

The judge did not give any insight into when he may issue his ruling on Louisiana's request for an injunction. However, he did give the FDA attorneys seven days to file a brief on any emergency action it would take if it were to find that mifepristone is indeed a public health risk.