The story of the abortion pill is one of steadily weakening protections for the mother from a drug expressly designed to be lethal to her unborn child. Initial limitations on who may prescribe the drug and what their health care credentials must be have eroded under Democratic administrations to a risky, laissez-faire regimen of no in-person medical supervision, no injury tracking, expanded gestational limits, and attacks on any research, such as that conducted by the Charlotte Lozier Institute (CLI), designed to identify the drug’s physical and psychological effects on women who take it or have it foisted upon them.

The new CLI review recaps this entire process of medical neglect while focusing only on the most recent actions under the Biden administration to facilitate unregulated and unmonitored distribution of mifepristone and its companion, misoprostol.

In the abortion regimen’s quarter century of FDA-authorized use in the United States, the agency has taken a series of self-reinforcing steps to increase the drug’s availability: approval of the drug with a risk evaluation and mitigation protocol purporting to provide for safe use (2000, 2007); increase in the gestational age for use of the drug from seven to 10 weeks (2016); elimination of the requirement for reporting of non-fatal complications after taking the drug (2016); and announcement of non-enforcement of the existing FDA requirement that the drug be dispensed only after an in-person examination and with follow-up (April 2021).

The CLI paper was researched and written by two Lozier scholars, obstetrician-gynecologist Ingrid Skop, M.D., FACOG, and Zachary Sluzala, Ph.D., the institute’s director of Policy Research, who holds an M.S. and Ph.D. in neuroscience from the University of Michigan. The paper is an exhaustive critical analysis focused on the most recent and consequential of the long string of FDA actions designed to make abortion drugs accessible by mail with little to no regulation or tracking of the consequences.

The heart of the Biden FDA action was repealing what is denoted as ETASU-C, the requirement that, before the drug can be prescribed, the woman (references to gender were gratuitously dropped by the activist Biden FDA in May 2021) have an in-person visit with qualified medical personnel. The authors note that the Biden FDA retained several other ETASU requirements, including certification of prescribing pharmacies but, as they thoroughly document, the ETASU-C provision is the linchpin of an interrelated set of policies. The authors succinctly describe the importance of ETASU-C because it:

“ensure[s] that prescribers had ready availability of patient medical and menstrual history (and, in turn, that high-risk women could be adequately identified for pre- and post-abortion testing including ultrasound), that drugs were prescribed and provided to the patients themselves, and that cases of abuse or coercion could be more easily identified.”

Most of the Sluzala and Skop critique of the inclusion or exclusion of various studies from what the FDA termed a “Mifepristone REMS Modification Rationale Review” centered on the lack of “real-world” analysis. The concept is fairly straightforward. To what extent can studies that rely on a set of maternal protections, including pre-abortion ultrasound and a post-abortion exam (as the original policies to ensure “safe use” did after the 2000 FDA approval), be cited in support of removing the very requirement that ensured these practices would be followed in real-world situations, that is, in the way the drug is actually dispensed?

The list of “real world” challenges that have appeared with mifepristone and misoprostol is large and growing. With the FDA’s scheme of general relaxation, advocates of abortion drugs advertise that they will provide or recommend the drug later in pregnancy (Planned Parenthood at 11 weeks’ gestation; contraception at 12-weeks’ gestation and above or at 12-20 weeks’ gestation; British Pregnancy Advisory Service at 24 weeks — though “not at home”).

Aided by shield laws that promote anonymity, mail-order abortion providers distribute the drug with minimal regard for who is actually ordering it and whether it is for involuntary or coercive use. Advance prescription sellers offer supplies of the drug to women or teens for potential use “down the road” when medical conditions, for the purchaser or a third party, are completely unknown to the provider. A riveting video of the chaos in which mail-order merchants will send the drugs even to women with strong contraindications to its use was recently released by the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG).

Sluzala and Skop chronicle how the Biden FDA applied disparate standards to its review of studies and submissions from AAPLOG and the American College of Pediatricians, which offered research and clinical evidence in a 2019 citizens’ petition seeking a fresh review of the FDA’s decisions to eliminate protective policies. Now that the Biden standards have stood for half a decade, including half of the second term of President Trump, what do the study authors recommend for corrective action? Sluzala and Skop acknowledge first and foremost the need for better data and for actors in the debate over mifepristone to recognize that conditions governing the use of the drug are dynamic and existing studies need elaboration and refinement. They have four “actionable recommendations.”

• Released the day before the Trump FDA told a federal court it would not have findings on its own review until three to six months from now, the report endorses a fresh FDA review with a serious effort to gather and compare data allowing for comparison of impacts after various FDA changes in the REMS policies. Among the suggestions is that the agency delve into large private insurance databases using complication codes in a standard time frame post-abortion to document the real-world effect of FDA changes. “If the FDA demonstrates increased harm,” the authors write, “it should reinstitute its previous REMS requirements in the interest of women’s safety.”
• Second, erring on the side of safety, Skop and Sluzala say, “Prior to the completion of the above review, the FDA should reinstate ETASU-C, considering the inadequacy of the evidence used to demonstrate the safety of its initial removal. Reinstating ETASU-C will ensure that, until a complete review of mifepristone’s safety can be conducted, its absence will not result in unintended risks to women.” For decades, the abortion industry sloganeered that abortion should be between a woman and her doctor. Now they seek to abolish the doctor, testament at least that abortion is not, as they see it, a medical event.
• Third, the authors urge the reinstatement of the reporting requirement for non-lethal harms of mifepristone. Any number of studies have underscored that the later in pregnancy mifepristone and misoprostol are deployed, the higher the rates of injury inflicted. Nothing was gained by masking data of this kind a decade ago. When data reporting is voluntary, data quality suffers, and adverse event counts — already diminished by the complexities of reporting and by deceit urged on abortion patients by pill providers — understate real-world harms.
• Finally, Sluzala and Skop write, the FDA should thoroughly investigate the manifold anecdotes and reports indicating that pill sellers are shipping the drugs without identity verification or professional evaluation of contraindications to its usage. They assert, “If this investigation reveals a larger trend, whether in general or for particular providers, the FDA should use enforcement mechanisms at its disposal to revoke REMS certification for non-compliant providers.” The evidence is strong that such providers, determined to sell and effectuate abortions as their top priority, do exist. The FDA does not lack enforcement tools to address and deter such behavior now.

The CLI critical analysis is both fair and compelling. It deserves the support of any public figure remotely concerned about the sanctity of life or maternal well-being. On October 9, Missouri Senator Josh Hawley (R) released a letter he has sent to the FDA urging it to pursue these issues as FDA officials have, on multiple occasions, pledged to do. Hawley wrote with particular concern that FDA may be relying on data from a database with a time-limited range. If so, he writes, “its analysis may rest largely on procedures that occurred before the 2023 REMS took effect and possibly exclude analysis of a large Medicaid population after that date,” a time period when millions of chemical abortions have occurred and verified clinical data is sparse at best.

Much more is at stake in these matters, of course, than the outcome of a data war. A profound issue of public policy is at stake, and the essence of the medical arts in an advanced society is also on the table. One can be forgiven for feeling a bit of pique when a standard line in a weight loss pharmaceutical ad comes across the airwaves and warns it “may harm an unborn baby.” The debate over mifepristone is not over a problematic side-effect but the essential purpose of the drug — to harm an unborn baby and to ensure that the drug to accomplish it is ubiquitous and all but hidden from the human conscience.

Chuck Donovan served as founder/president of Charlotte Lozier Institute (CLI) from 2011 to 2024. He is currently a strategic advisor to CLI. He played no role in the planning, research, drafting, editing or production of the paper described in this article.