On Tuesday, the Supreme Court will hear oral argument in the F.D.A. v. Alliance for Hippocratic Medicine. The case is the first to address abortion—in this case chemical abortions—since the 2022 Dobbs decision which overturned Roe v. Wade.
The following are just five of the many questions swirling around the way the FDA considered mifepristone and loosened regulations on its distribution and use.
#1. Is pregnancy a life threatening disease or illness?
When the FDA approved mifepristone in September of 2000, it did so under a statutory provision called “Subpart H” reserved the accelerated approval of emergency drugs needed for “serious or life threatening illnesses.”
Does the FDA consider pregnancy a “life threatening disease” or “illness?”
Pregnancy is a natural, normal, healthy condition for which women’s bodies are well suited and adapted. It is the way all of us are brought into the world. Though there are rare occasions where something goes wrong, chemical abortion with mifepristone is generally not considered the best way to deal with these emergencies.
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Since the vast majority of chemical abortions are for healthy women with healthy babies, what was the drug agency’s rationale for approving mifepristone under this special, unique provision?
#2. How can you assure the public these drugs are safe when the tests you rely upon are missing the results of nearly a quarter of the women taking the pills?
The FDA and Danco, the maker of mifepristone, regularly cite studies by abortion pill advocates claiming that serious complications are “less than one percent.” While there are serious questions as to the criteria advocates use to determine whether or not a complication is “serious” (apparently hospitalization counts, but not surgery or hemorrhage so long as it is treated in the Emergency Room), more disturbing is the assumption that patients with whom the study loses contact are doing fine.
Women encountering significant bleeding episodes, signs of infection or ectopic pregnancy–particularly if they never met their prescriber in person and got their pills by telemedicine–may be unlikely to try and reach an online prescriber in another state. For these women, it likely makes much more sense, medically and logistically, to visit their local ER or their own personal doctor where they can get immediate emergency treatment.
We know that it is already the case that many abortion pill providers automatically direct their patients to go to their local emergency departments if they are losing significant amounts of blood. Some suggest that ER personnel need not be told that the woman has taken abortion drugs, that she can simply tell them she is having a miscarriage and receive needed treatment.
This not only may result in her doctor being uncertain as to the appropriate cause or treatment but may contribute to a distorted picture of the drug’s safety in any surveys.
#3. What evidence do you have that the bleeding and infection problems and the issues with undetected ectopic pregnancy which manifested themselves in the drugs early days have been addressed by any of the changes you have made to the protocol since 2016?
In 2016, at the behest of the Danco, the Obama administration, and the abortion industry, the FDA made serious changes in the protocol. The FDA loosened REMS (Risk Evaluation and Mitigation Strategy) regulations and extended eligibility for the drugs to women up ten weeks past their last menstrual period (LMP); broadened the prescriber pool to any “certified healthcare provider”; and dropped the number of required visits to one initial encounter for the woman to be screened and pick up her pills.
They even dropped this single visit requirement in subsequent changes made to the protocol in 2021 and formalized in 2023. Women were allowed to get these pills by telemedicine without an in-person physical exam and have the pills shipped to their homes.
Again, what evidence did the FDA have regarding the safety of these modifications, that removing all these safeguards simultaneously would not result in more injuries or complications?
Relying on studies which looked at only a single factor (e.g., expanded providers) in isolation and which had lost track of a quarter of patients or more (particularly an issue with telemedicine) was clearly problematic from a medical and statistical standpoint. The fact that the FDA stopped requiring the reporting of non-lethal complications after 2016 only made the evaluation even more dubious.
#4. If complications increase and efficacy decrease with gestation, why was the decision made to extend the protocol deadline and not to require a physical examination or ultrasound?
Studies have repeatedly shown that complications increase and effectiveness decreases with mifepristone the farther along the woman is in her pregnancy. This was the reasoning behind the FDA’s original seven week LMP cutoff and ostensibly the reason they didn’t extend the cutoff past ten weeks in 2016. (It doesn’t appear that there had been any improvement in efficacy after seven weeks, but the FDA decided that though decreased, the effectiveness of mifepristone at ten weeks was still sufficient to allow use.)
If this is so, the estimation of gestational age is a critical factor in determining whether or not the abortion pills are going to work and whether they might lead to life-threatening complications.
Ideally, the best way to determine gestational age is with an ultrasound, which would require visit to a medical office and an appointment with an ultrasonographer. This would also allow for the discovery of any possible ectopic pregnancy, where the child implants outside the womb, a dangerous condition affecting 1-2% of pregnant women, which mifepristone does not treat.
At a minimum, though, a pregnant woman should be physically examined by doctor trained to determine gestational age and rule out ectopic pregnancy.
Abortion advocates presume that this can be done by an online or text interview, though they admit that a number of ectopic pregnancies and over age gestations slip through. Does the FDA just consider these “acceptable losses?”
#5. In the REMS, the FDA says that sponsors must de-certify any prescriber who fails to fulfill the conditions of certification. Has the FDA or Danco pulled the certification of any prescribers or groups which advertise or perform abortions at 11, 12 weeks LMP, or later?
Adverse Event Reports (AERs) submitted to the FDA regularly showed mifepristone being used at gestations of 11, 12, 13 weeks or more and various certified mifepristone prescribers explicitly advertise willingness to perform chemical abortions up to 11 weeks (or more).
If the FDA continues to believe that REMS are necessary to ensure safe and effective use of these drugs, why has it failed to enforce these regulations or not made the public aware of any enforcement actions?
If violation of these protocols truly endanger the health and safety of American mifepristone patients, then why isn’t the FDA enforcing these limits to guarantee safe use?
