The case against medical abortion rejects science and embraces falsehoods

On Nov. 18, a group of antiabortion activists sued the Food & Drug Administration (FDA) to try to remove mifepristone from the market. Mifepristone is the only drug that is FDA-approved to terminate a pregnancy. The lawsuit is based on several fundamental mischaracterizations of the FDA’s decision-making and the scientific evidence surrounding medication abortion.   

If this lawsuit is nevertheless successful, it would apply nationally and remove the drug from the market throughout the United States. It is therefore another reminder that the antiabortion movement will not stop with overturning Roe v Wade and banning abortion in half the country— its goal is to stop abortion everywhere.  

Medication abortion has become the most common way to end an early pregnancy in the United States, with over 50 percent of abortions occurring with medication in 2020. Many people prefer medication abortion over procedural abortion because it is less invasive, more private and does not require anesthesia. Innovations in abortion care — blessed by the FDA at the end of last year — now allow patients to end an early pregnancy using a virtual clinic, never needing to leave their homes. Remote medication abortion is not only very safe and effective but also cheaper and less burdensome, which can significantly improve abortion access given that the average abortion patient is poor or low-income and already a mother.   

The plaintiffs in this new lawsuit want to take us back to a time when medication abortion did not exist, overwhelming brick-and-mortar clinics and making abortion financially and logistically inaccessible for even more people. The anti-abortion movement knows that abortion pills have blunted some of the trauma of overturning Roe and will go to great lengths to prevent access, including filing a frivolous lawsuit. As FDA law scholars, we want to highlight a few important misconceptions in the plaintiff’s complaint.  

The lawsuit alleges that the FDA inappropriately used its Subpart H authority to approve mifepristone. The FDA’s Subpart H authority is reserved for drugs that treat “serious or life-threatening illnesses.” The plaintiffs argue that the FDA’s use of Subpart H was evidence of unusual leniency, and meant the agency failed to give the drug a full review. This is simply not true.  

First of all, the FDA rejected mifepristone’s new drug application twice, requesting an additional clinical trial, labeling changes, and restrictions in distribution, before finally approving it over four years after it was originally submitted. This drug was not approved quickly or haphazardly — the entire European Union had access to mifepristone before the FDA approved it in 2000.   

Second, the manufacturer of mifepristone objected to the FDA’s use of Subpart H; not because it was too lenient, but because it was too harsh. Though Subpart H allows the agency to approve a drug based on a surrogate endpoint that might be faster to study than a clinical endpoint, the agency did not do so for mifepristone. However, Subpart H also allows the FDA to condition a drug’s approval on distribution restrictions, which is what the agency did for mifepristone. In other words, the agency regulated mifepristone under Subpart H in a way that made the drug  harder  to access, not easier.  

The mifepristone sponsor tried to avoid Subpart H by arguing that the classification would inappropriately identify mifepristone as a risky drug, but the FDA determined it would condition mifepristone’s approval on post-market distribution restrictions, and thus, Subpart H was necessary.   

Ever since mifepristone has been on the market, the FDA has limited the providers that can prescribe the drug, required extra informed consent, and until last year, prohibited pharmacies from dispensing it. In other countries, however, mifepristone has been widely available, and used safely and effectively, without such restrictions. Thus, many have argued that the FDA’s regulation of mifepristone has been overprotective, making it ironic that the origination of those onerous regulations, Subpart H, is now being used as evidence of leniency.  

Nevertheless, due to concerns on both sides that the FDA’s use of Subpart H was inappropriate, the Government Accountability Office conducted a 55-page audit, which found, among other things, that the FDA’s approval of mifepristone was consistent with its approval of other drugs.  

This is not the only manipulation of science and history in the Texas lawsuit. Another false claim that plaintiffs make is that medication abortion is unsafe. Medication abortion is one of the most studied drugs on the planet. It has been in use for over 20 years in the United States and has a safety record that is superior to Viagra and Penicillin. It is also 14 times safer than the alternative: childbirth.   

Though some studies indicate that medication abortion may be slightly less effective than procedural abortion, the reality is that both medication and procedural abortions are extremely safe and effective, and the choice between them is best left to patient preference.   

Though this lawsuit is about abortion, if successful, its effects won’t stay limited to abortion, or even to contraceptives and reproductive health care products. The lawsuit comes against the background of growing challenges to the government’s authority to protect and promote public health, often grounded in misinformation. This lawsuit’s arguments are far from the first time the antiabortion movement has embraced falsehoods, but it is a troubling sign of things to come.   

A victory here could have collateral consequences that limit the FDA’s ability to ensure the safety and effectiveness of the medications that our nation’s patients need, undermine incentives to develop innovative new treatments and diminish our collective ability to address pressing public health challenges. If misinformation can remove one of the safest drugs from the market for political reasons, harming women’s reproductive health care nationwide, then we risk creating public health policy that is ruled by the views of those with the resources to push lawsuits no matter how weak their merits, not expert judgment. 

 Greer Donley is a John E. Murray Faculty Scholar and associate professor of law at the University of Pittsburgh Law School. Patricia J. Zettler is an associate professor at The Ohio State University Moritz College of Law and a member of Ohio State’s, Comprehensive Cancer Center and its Drug Enforcement and Policy Center.