The U.S. Food and Drug Administration wants a federal court to halt a lawsuit from Louisiana and an abortion pill poisoning survivor demanding the agency end the Biden administration’s “illegal” mail-order abortion pill permissions. The plaintiffs and pro-lifers who back the case, however, say a pause and denial of preliminary injunction will only put women and babies at more risk.
In its memorandum filed on Tuesday, the FDA claimed legal challenges to the radical expansions that make it easier for people to obtain mail-order mifepristone and initiate at-home abortions without medical oversight are “disruptive” and possibly “unnecessary” in light of the agency’s ongoing mifepristone review.
“The rationale for deferring judicial review is simple: the ‘harm of moving forward’ with judicial review of the 2023 REMS Modification outweighs the ‘harm of holding back,’” the memo states.
No review is required for the FDA to reinstate some of the common-sense abortion pill safeguards, such as an in-person doctor visit, that were stripped from the FDA’s Risk Evaluation and Mitigation Strategy (REMS) under President Joe Biden’s watch. In fact, doing so would match the second Trump administration’s mifepristone parameters with those present during the first Trump administration.
The FDA, however, signaled it does not plan to act on those REMs until its review is complete. The filing goes so far as to claim that plaintiffs such as Rosalie Markezich, who lost her baby after being allegedly coerced into taking abortion drugs that her boyfriend mail-ordered against her consent, “threaten to short circuit the agency’s orderly review and study of the safety risks of mifepristone.”
Additionally, the FDA suggested that awarding the growing number of lawsuits the preliminary relief they desire could “sow administrative and judicial chaos” such as the conflicting injunctions out of Texas and Washington in respective challenges to the FDA’s 2000 mifepristone approval and 2023 REMS.
The 20-page document ends with the defendants declaring that Markezich, despite suffering an abortion pill poisoning, lacks standing. According to the FDA’s counsel, Markezich’s assertions that she could face another forced chemical abortion under the FDA’s current policies is “insufficient to satisfy the injury-in-fact requirement.”
“FDA’s review will necessarily result in a new agency decision that could supersede the 2023 REMS Modification, obviating any need to consider the merits of Plaintiffs’ arguments challenging the validity of the 2023 REMS Modification,” the memorandum states. “Any party adversely affected by the new agency decision on mifepristone may seek judicial review
at that time. And in the event of a further REMS modification, adherence to FDA’s normal process will create far less disruption than the abrupt, judicially imposed change sought by Plaintiffs.”
Pro-lifers vehemently disagree. While the FDA mifepristone review is considered a small victory for the organizations hoping to save women and babies from the suffering linked to mifepristone, it is not enough to stop the most popular abortion drug in the U.S. Stories of women, even those in states where chemical abortion is banned, suffering injuries and even death after taking or being force fed abortion pills without medical supervision continue to surface alongside studies showing mifepristone is more dangerous than previously thought.
“There is no reason that the FDA couldn’t immediately reinstate [mifepristone’s] in-person dispensing requirement while at the same time doing a thorough safety review to see if more safeguards need to be put back into place,” American Association of Pro-Life OBGYNs CEO Dr. Christina Francis declared.
SBA Pro-Life America President Marjorie Dannenfelser warned that “Women and children are dying and do not have ‘a year or more’ to wait on the FDA.”
“They deserve safeguards NOW,” she said.
Kristen Waggoner, President, CEO, and Chief Legal Counsel of Alliance Defending Freedom, encouraged the Trump administration on X to “stand with Louisiana—not with abortion extremists like Gavin Newsom and Letitia James.”
Louisiana Attorney General Liz Murrill framed the FDA’s memo as “an affront to our sovereignty and the dignity of women and the unborn.”
“FDA should stand with us for life, not with @CAgovernor and @GovKathyHochul,” Murrill wrote.
Mere weeks ago, Murrill warned in a Senate hearing that until the FDA reimposes the mifepristone safeguards stripped away by Biden, “Louisiana’s efforts to protect mothers and their unborn children and to hold out-of-state abortion pill traffickers accountable for the harm they inflict will be all but futile.”
A recent McLaughlin and Associates survey found that 71 percent of likely voters approve of the FDA requiring a doctor visit to obtain an abortion drug prescription. Three-in-five respondents even went so far as to agree that “chemical abortions are far more dangerous than advertised, and women deserve a doctor’s care to prevent serious health complications like hemorrhaging, bleeding, or infections.”
Approximately seven in 10 of those surveyed, after agreeing that “chemical abortion drugs are used by sexual abusers to cover up rape, exploitation and sex-trafficking,” said doctors should also be required to “screen for and report signs of coercion or abuse” before prescribing mifepristone.
The FDA previously failed to answer The Federalist’s questions about how long the review is estimated to take. The Tuesday memorandum emphasized that the agency is working on a Mifepristone study that would usually “take approximately a year or more to conduct.” Makary’s FDA, however, is aiming to complete it in a “sooner than that timeframe.”
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