Opinion Brief on Mifepristone
Mifepristone, a medication that can be used in abortion care, will be a target of the new administration.
In our December 2023 opinion editorial (op-ed), Genevieve Grabman and I reviewed the Supreme Court’s analysis of the legality of and access to this medication, focusing on the argument that medication abortion should not be FDA regulated, because pregnancy is not a medical condition.
My co-author on this is Genevieve Grabman, a lawyer who has written about abortion and the politicization of prenatal care in her book, Challenging Pregnancy.
In December 2023, the Supreme Court granted the Biden administration’s and pharmaceutical company Danco’s petitions to review the propriety of the FDA’s decisions in 2016 and 2021 to make mifepristone more widely available as an abortion medication. The Supreme Court stayed, or stopped, the suspension of mifepristone access; and for now, the medication remains legal in all US states.
Mifepristone was approved by FDA in 2000 for pregnancy termination, and has been used millions of times since then to end early pregnancies privately. In 2016, FDA increased gestational age limits when mifepristone could be used to terminate a pregnancy, reduced the number of required doctor’s visits to obtain the drug, and allowed some non-physicians to prescribe the drug. In 2021, FDA removed the in-person dispensing requirement for mifepristone. The Fifth Circuit deemed those changes arbitrary and capricious, ruling FDA had no right to make them and suspending access to mifepristone. If the Supreme Court upholds the Fifth Circuit’s ruling, pregnant people in a swath of states without access to surgical abortion would not have access to medical abortion, either.
The Fifth Circuit’s decision included language supporting the anti-choice argument that FDA has no jurisdiction over pregnancy termination medication because pregnancy is not a disease. This ruling should be concerning to everyone who believes in the rule of law and wants medical products to be appropriately regulated. For more than a century, FDA has been regulating at least some medical products, which are currently defined as those to treat, cure, mitigate, prevent or diagnose a disease or condition.
The questions raised for the Supreme Court apply not only to mifepristone but also to the regulatory structure that underpins our drug review system in the United States. That review, long considered the world’s gold standard, has ensured for decades only safe and effective drugs are marketed in the US and that violations do not go unpunished. Mifepristone’s challengers undermine the expertise of the FDA to review all evidence and make a determination of safety and efficacy. More than 20 years of data showing that mifepristone is safer than many over-the-counter drugs has supported FDA’s actions.
Plaintiffs argued among other things, that since pregnancy is not a disease, FDA has no jurisdiction over medication abortion. If this were true, not only would FDA not have jurisdiction over medication abortion, but also over
Menstrual products, as menstruation is not a disease
Other forms of birth control
Medical care for injuries — njuries are not a disease, but the treatment of them, including the medical care and the products, are currently and should continue to be, regulated as health care
Anesthesia does not address any “disease”
Is organ rejection a “disease”? If not, then drugs to ensure that transplant patients don’t reject their organs would not be FDA regulated.
Colonoscopy preparation solution, which merely clears out the GI tract, does not treat or diagnose a disease.
Contrast agents, which Congress just made clear are drugs, aren’t FDA-regulated medical products under the reason of the anti-choice activists.
Further, there are medical conditions that have the word “syndrome” in them. These medical conditions such as polycystic ovarian syndrome (PCOS), Chronic fatigue syndrome and irritable bowel syndrome (IBS) are not “diseases”. Treatments for those conditions should be evidence based and regulated as medical products.
Lastly, some of the normal symptoms of aging, such as presbyopia and hearing loss, are not diseases.
Other conditions that are diseases but not always recognized as such, like addiction, could become as political as abortion. Yet, medications to address addiction need regulation.
In regulating mifepristone, FDA examined more than 500 pages of drug data, more than 40 studies published on the safety of the drug, and 15 years of reporting about adverse effects of mifepristone. The Department of Justice’s petition for certiorari to the Supreme Court points out that “[n]o studies or other reliable evidence suggest that FDA’s 2016 and 2021 actions have had a substantial effect on the likelihood of adverse events [of taking mifepristone]... In fact, the record demonstrates that serious adverse events remain extremely infrequent…”
The Fifth Circuit adopted a “novel and unworkable legal framework for reviewing FDA’s drug approvals” when it ruled that FDA’s decisions in 2016 and 2021 were improper because FDA did not understand the cumulative effect of the regulatory changes it made. Yet, never before has a court invalidated FDA’s approval of a drug based on a disagreement with FDA’s assessment of safety and effectiveness. FDA is the expert body for evaluating drugs’ and devices’ safety and efficacy - not the courts.
In addition, upholding the Fifth Circuit’s decision would reimpose a pre-2016 regulatory regime for mifepristone. Neither the dosing nor the prescription conditions would be correct for the medication, and the drug would be misbranded. As FDA’s Principal Deputy Commissioner explained, staying FDA’s 2016 and 2021 actions would “create significant chaos for patients, prescribers, and the health care delivery system.” This chaotic whirlwind soon would envelop other medications opposed for moral and not scientific reasons.
FDA drug approval does not come with any requirement of a provider to prescribe the medication. No one is being forced to have or be part of an abortion. The medical providers seeking to remove mifepristone from the US market take issue with an evidence-based decision clearly in a regulatory agency’s purview because they fear harm from an attenuated parade of vastly unlikely horribles: encountering a patient who has taken mifepristone, is experiencing an adverse event, has sought care from an anti-abortion medical provider who cannot refer the patient to a colleague, and who is obligated to treat the patient. None of these wild assumptions has come to pass. No drug approval will be stable if drug makers must assure prevention of all speculative harm.
Should the Supreme Court uphold the Fifth Circuit’s decision blocking mifepristone access, it would counter decades of legislation and jurisprudence and yield results that could upend the entire medical regulatory system. This would serve only to decrease the safety and effectiveness of medical products, which would harm patients. We urge those who object to medication abortion to exercise their rights regarding their own bodies and leave the rest of us to rely on the FDA, follow the science, and do what is best for us.