FDA safety review of abortion pill may extend past midterms, infuriating pro-life bankroller

When a medical transparency group sought all records on the government's approval of Pfizer's COVID-19 vaccine, the Food and Drug Administration told a court it would need 55 years to redact them under Freedom of Information Act exemptions. The gambit didn't work.

The FDA won't take that long to finish an abortion pill's safety review, which was prompted by a think tank report last spring, promised by Commissioner Marty Makary in June and reiterated by Health and Human Services Secretary Robert F. Kennedy Jr. in September, but the agency can't give a specific timeframe.

The Justice Department told a federal court hearing a challenge to FDA deregulation around mifepristone — once better known by its research code "RU-486" and even name-checked on The Simpsons — that the FDA plans to complete the review "sooner" than the typical "year or more" for safety reviews, so challengers must wait.

At least temporarily protecting its Democratic predecessors' repeated loosening of the pill's rules, culminating in the permanent removal of the in-person dispensing requirement in 2023, the Trump administration said Louisiana Attorney General Liz Murrill and a resident allegedly coerced into taking mail-order mifepristone were trying to "short circuit" its own review.

DOJ asked the U.S. District Court in Lafayette, La. to "exercise its inherent authority to stay this litigation pending the outcome of FDA’s review" of the risk evaluation and mitigation strategy around mifepristone and reject the plaintiffs' motion for preliminary relief, which would erase the 2023 REMS modification.

But there's no guarantee the FDA would finish the REMS review of mifepristone, which is taken with misoprostol to suffocate and starve a fetus to death and expel it from the uterus, if the court paused the case, even if Makary wasn't allegedly slow-walking it. 

The Biden administration was similarly confident it could replace its predecessor's Title IX regulations with its own, expanding the definition of "sex" to include gender identity, convincing plaintiffs to pause their challenge to President Trump's rules. Courts then repeatedly blocked President Biden's proposed rules, and the one-termer ran out of time.

Susan B. Anthony Pro-Life America, a financial behemoth in Republican primary politics, denounced the administration for trying to shut down Murrill and Rosalie Markezich, the Louisiana "abortion drug coercion survivor" who said her baby died from mifepristone she took under duress from her ex-boyfriend, who obtained it from California through the mail.

"As abortions in America go up instead of down, women are coerced, poisoned and ending up in emergency rooms, and state laws are undermined, it is states like Louisiana that are leading the charge," yet the administration protects "unscrupulous drug dealers" by retaining Biden policies devised as a COVID-19 pause, SBA President Marjorie Dannenfelser said.

She was puzzled why the feds would float dragging the safety review past this fall's congressional elections, given that Kennedy has claimed the prior administration "twisted the data" on the pill's safety and Makary said the FDA counted more than 400 women who needed blood transfusions after taking the pill from 2000 to 2012, before the wave of deregulation started.

“The more the Trump-Vance administration drags its feet, the worse it is for them ahead of midterms," Dannenfelser said. "Ignoring the pro-life base is a tremendous miscalculation," especially since even most liberal voters favored in-person dispensing requirements for medication abortion in a national survey SBA commissioned last fall.

SCOTUS rejected 'makes-state-crime-possible theory'

DOJ's motion said the FDA is trying to act on the 5th U.S. Circuit Court of Appeals' own concerns, in a challenge by pro-life doctors, that the FDA justified the 2021 suspension of in-person enforcement based on an adverse event reporting system that it had crippled years earlier, under President Obama, and by citing weak and even irrelevant studies. 

Though the Supreme Court said the doctors didn't have standing to sue, the FDA still wants to settle the scientific issue in light of "litigation for many years" that goes beyond Louisiana, DOJ said. Missouri, Idaho, Kansas, Florida and Texas are either challenging the pill's original approval or deregulation, while other suits oppose current restrictions.

Not only are the Louisiana litigants seeking to upend an "orderly" review by FDA experts that may end in their favor, but if they succeed in striking the 2023 REMS change, other plaintiffs might "seek a conflicting injunction that would sow administrative and judicial chaos," as happened when a Texas court in 2023 blocked the FDA's original approval, DOJ said.

It said Murrill and Markezich won't be hurt by waiting for an FDA review to conclude, since the Pelican State "waited nearly three years to challenge" the 2023 change and can still make its own pro-life laws, while the "tragic injury" Markezich suffered "is neither traceable to FDA nor redressable" by a REMS change. 

Louisiana can't claim sovereign harm simply because enforcing its own laws is harder when mifepristone can be mailed to its residents from out of state, DOJ said, citing SCOTUS rejection of a "makes-state-crime-possible theory" when Texas and Louisiana unsuccessfully sued to block the Biden administration's selective enforcement of immigration laws.

SCOTUS also rejected the logic of Louisiana's argument that it has standing as a Medicaid payor when the high court tossed the doctors' lawsuit against the "loosening of general public safety requirements simply because more individuals might then show up at emergency rooms or in doctors’ offices with follow-on injuries" from mifepristone, DOJ said.

"If the chain of causation between the challenged agency action and the doctors’ alleged injury is already too attenuated," as SCOTUS found, "adding a link (doctors cause Medicaid to incur costs) only weakens it more," DOJ said. Louisiana cannot challenge "any federal policy" it claims caused a doctor or hospital visit that it paid for via Medicaid.