Popular restrictions on abortion pills may come back on eve of midterms, under mixed court ruling

The Food and Drug Administration has until four weeks before midterm elections to convince a federal court that it's not slow-walking a promised safety review of an abortion pill whose prescribing conditions were repeatedly loosened by Democratic administrations.

If U.S. District Judge David Joseph isn't satisfied by "the status of its review in terms of process and any updated timeframe for completion of review," he might reinstate restrictions on the pill, mifepristone, over the objections of the Justice Department, Joseph implied in a Tuesday memorandum ruling in a lawsuit by Louisiana and a resident coerced to take the pill.

Such an October surprise could boost Democratic turnout in midterms already expected to be a bloodbath for Republicans, albeit months later in the cycle than the Supreme Court's elimination of federal abortion rights in Dobbs, which reportedly drove about a quarter of voting decisions in the 2022 midterms and energized voters to protect abortion in red states.

Pro-life primary behemoth Susan B. Anthony Pro-Life America has warned from the other direction that failure to rein in mifepristone, especially the mail-order option approved as a temporary COVID-19 measure in 2021 and made permanent in 2023 to circumvent red-state restrictions, could depress midterm enthusiasm among a third of GOP voters. 

While Joseph agreed to stay the litigation for six months so the FDA can complete its Risk Evaluation and Mitigation Strategies review of a pill that suffocates and starves a fetus to death, the pause "will not remain open-ended," the President Trump nominee emphasized. 

The agency "has an obligation to act with all deliberate speed to review its past actions and complete a thorough analysis that addresses the deficiencies it has acknowledged," namely the "dearth of information" behind the removal of in-person prescribing requirements, expansion of the gestation window and permission for non-doctors to prescribe the pill, he said.

The 2016 regulatory change also removed in-person requirements to administer fetus-expelling misoprostol and follow up with the patient and eliminated "prescribers’ obligation to report non-fatal adverse events," without considering "any data that cumulatively evaluated the effect" of these changes, Joseph said, citing a 5th U.S. Circuit Court of Appeals decision.

"Should the agency fail to complete its review and make any necessary revisions to the REMS within a reasonable timeframe, the Court’s analysis – and the weight accorded to these factors – will inevitably change," Joseph wrote, referring to the plaintiffs' arguments to block the 2023 REMS change with the permanent mail-order authorization.

Louisiana Attorney General Liz Murrill touted Joseph's findings that the Pelican State has legal standing and is likely to prevail on the merits of its argument that the 2023 REMS change was arbitrary and capricious, violating the Administrative Procedures Act (APA).

"He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect," she said in a statement given to Just the News. "Accordingly, under binding Fifth Circuit precedent, the only thing left to do is vacate the 2023 REMS pending the outcome of this litigation. We will ask the Fifth Circuit to do so."

SBA Pro-Life America also accentuated the positive in Joseph's findings that the plaintiffs would be likely to win the case but for the FDA finishing its REMS review.

"The Trump-Vance administration should stand with Louisiana and other states to enforce their laws and protect women and unborn children, rather than defending Biden’s disastrous COVID-era policies," President Marjorie Dannenfelser said.

“The administration’s choice to fight against survivors, the states, and their own base means they will be back in court to explain their timeline directly in the lead-up to midterm elections," when it could simply "bring back safety standards the majority of Americans support," she also said, referring to 63% public support for in-person prescribing in a Reuters/Ipsos poll. 

The Department of Justice did not answer a query for its response to the ruling.

No warning letters to illegal abortion pill marketers in Trump II

The Trump administration is facing parallel headaches from Congress, where Louisiana GOP Sen. Bill Cassidy, the health committee chairman, and four other Republican senators are bearing down on FDA Commissioner Marty Makary to immediately ban the U.S. marketing of "misbranded and unapproved versions" of mifepristone and misoprostol online.

The FDA only halfheartedly discourages consumers from buying mifepristone online and tells them about the "serious health risks" of doing so on a low-visibility web page, despite a more prominent web page warning consumers against buying any unapproved drug, the March 25 letter says.

A poll last month for the conservative-leaning 85 Fund conducted by CRC Research found 67% of respondents said they would support the FDA reinstating an in-person doctor visit requirement for accessing an abortion pill via the mail. Seventy-two percent of respondents who identified as Republican were in support, compared to 68% for independents and 63% for Democrats. The polling was conducted from March 12-18 and sampled 1,600 likely voters. 

The FDA has been on notice since 2018 that more than 70 "unique" websites are illegally selling and shipping abortion drugs and that two-in-five "falsely claimed to be selling FDA-approved versions of the drug," the letter said, citing the pro-life Charlotte Lozier Institute.

Some are "seemingly U.S.-based online clinics" but "many openly market" licensed drugs beyond the 10-week gestation window in the 2016 REMS change, while foreign clinics especially in India sell "unapproved and misbranded" versions and tell women to lie to doctors if they experience severe adverse events, the letter says.

Community networks import illegal pills from India and Mexico to distribute, "often for free," without even requiring "a cursory online intake form," while foreign online pharmacies ship illegal pills masquerading as FDA-approved versions and even "encourage U.S. contacts to purchase a bulk order" and resell them for profit, according to the senators.

The FDA has yet to issue a warning letter to purveyors of illegal abortion drugs in the second Trump administration, despite sending 62 related to unlawful online sale of other drugs since the president's second inauguration, the letter says. 

The first administration sent two warning letters to abortion drug purveyors but now must back its threats by issuing abuse complaints to internet domain name registrars and coordinating with Customs and Border Protection, U.S. Postal Inspection Service and DOJ on interdiction and prosecution, the senators demanded.

The FDA did not answer a query for its response to the senators, who gave it a deadline of April 8.

'Emergency room care is statistically certain'

Judge Joseph distinguished the challenge by Louisiana and mifepristone victim Rosalie Markezich from unsuccessful challenges by doctors who provide emergency care to women for mifepristone harms, whose "asserted injuries" the Supreme Court ruled "were speculative and not fairly traceable to the challenged FDA actions."

The legal standing determination by SCOTUS did not affect the 5th Circuit's identification of "regulatory deficiencies" in REMS changes after mifepristone's initial approval in 2000, which Health and Human Services Secretary Robert F. Kennedy Jr. and Makary acknowledged when they promised a safety review, Joseph emphasized.

At this early stage of litigation, Louisiana has shown standing because "out-of-state medical providers" responded to the 2023 mail-order revision by "expanding mifepristone access to pro-life states like Louisiana in ways that were entirely predictable" and the White House responded to Dobbs by seeking to protect abortion access "nationwide," the ruling says.

If the FDA "exceeded or abused the power vested in it by Congress" under the APA, as the 5th Circuit twice determined was likely in the removal of the in-person prescribing requirement, "then Louisiana clearly has an interest in vindicating its sovereign prerogative under basic principles of federalism," the judge said.

Even if the 2023 revision is not the "sole cause" of harm to Louisiana, which also must deal with other states' shield laws against out-of-state prosecution of their own medical practitioners and "the usual practical and investigatory impediments" of drug interdiction, "it has surely 'exacerbated' them" for standing purposes, Joseph said.

The state has also shown past and ongoing "pocketbook injury" because it must pay a portion of total federal Medicaid costs and the FDA's own documentation shows "emergency room care is statistically certain" in mifepristone cases, the ruling says.

The 2023 FDA label says 3-5% of women who take mifepristone as directed by a doctor in person will require an ER visit, and "empirical evidence" suggests the ER visit rate may be closer to 10% for patients who take it at 11-12 weeks, Joseph said.

Louisiana documented $92,000 in Medicaid costs in 2025 for just two ER visits following abortions caused by mifepristone from out-of-state prescribers, and "it is likely that many more Medicaid patients have required similar care due to complications from mifepristone," the judge said. As long as "Louisiana’s harm is more than zero," it has standing.