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A panel of federal judges appeared sympathetic to arguments that mifepristone, one of two drugs used to induce a medication abortion, should be restricted in some way.
The judges, three members of the conservative-leaning U.S. Court of Appeals for the Fifth Circuit, heard arguments Wednesday in a case challenging the Food and Drug Administration’s approval of mifepristone. Their ruling could send a message to the Supreme Court, which many legal observers expect will ultimately decide the case. The appeals court’s ruling, which could come at any time, will not have any impact on mifepristone’s availability.
A case like this is without precedent and, former FDA commissioners have warned in court-submitted briefs, could severely impair the agency. Pharmaceutical companies have also suggested that revoking mifepristone’s approval could discourage them from bringing new drugs to market.
In their questions, the judges frequently mischaracterized how mifepristone is used and how it was approved by the FDA, and incorrectly suggested it is a more dangerous drug than the evidence shows. Two judges hearing the case were appointed by former President Donald Trump, and the third was appointed by President George W. Bush.
Lawyers for the federal government and Danco, which manufactures mifepristone, both had to correct the three judges on multiple occasions about how the FDA approves medication and how it approved mifepristone.
Judge Cory Wilson suggested that if mifepristone is prescribed by any health care provider other than a physician, it would be “much more likely” that a patient requires emergency care. That, government lawyers noted, is incorrect — currently, medication abortion can be administered in some states by nurse practitioners and physician assistants, and the rate of complication remains incredibly low.
Judge Jennifer Walker Elrod, appointed by Bush, asked lawyers to clarify how telemedicine works, inquiring at one point if health care providers simply summarize the risks of medication abortion “in an email.” Virtual medical care is rarely provided over email, and usually the prescriber communicates with a patient over some form of phone or video service.
Judge James Ho expressed skepticism that pregnancy-related care should be regulated by the FDA, arguing that “pregnancy is almost certainly not an illness.”
Pregnancy-related complications can seriously impair people’s health and in many cases can be fatal — an issue that has only worsened in recent years — and improving the nation’s pregnancy-related health outcomes has been frequently labeled a top priority by public health institutions.
The case, originally filed in Amarillo, Texas, was brought by a group of anti-abortion medical providers who argued the drug was improperly approved by the FDA. The plaintiffs incorrectly claimed that the drug was rushed to market, and said that the government should rescind its approval and block its distribution.
Mountains of research shows that the drug, which was approved by the FDA more than 20 years ago, is effective in ending a pregnancy when used in a two-drug regimen alongside misoprostol, and complications are very rare. The FDA took four years to approve the drug, making it available in the United States years after it was already in use in Europe.
Much of the hearing focused on questions of legal standing, or whether the plaintiffs have the right to challenge mifepristone’s approval. Lawyers for the government and Danco both argued that the medical providers are not directly harmed by the drug’s approval and therefore lack standing to bring the case. But the three judges seemed skeptical of those points.
Restricting access to medication abortion has become a priority for anti-abortion advocates. In Wednesday’s hearing, Erin Hawley, the attorney for the plaintiffs, criticized “mail-order abortions,” arguing that making mifepristone available over telemedicine has allowed people to circumvent state abortion bans. Though people have ordered mifepristone online in states with abortion bans, they have largely done so outside the American medical system — ordering medication from providers in Mexico and Europe, which aren’t bound by state abortion laws.
A ruling limiting access to the drug would have implications across the country, potentially cutting off access to mifepristone or adding restrictions to how it can be used. The case, some legal scholars have suggested, offers a first clue into how the federal courts could be used to implement national restrictions on abortion — even though the Supreme Court argued last summer, in its decision overturning Roe v. Wade, that the issue should now be left to state governments.
Medication abortions can be done effectively using only misoprostol, though there is a slightly higher failure rate, greater risk of patient discomfort, and patients will often need more pills. Clinics could also perform only surgical abortions, but those can require more space and resources to operate, a challenge in particular for abortion providers that have been overwhelmed by an influx in out-of-state patients.
The Amarillo-based federal judge, Matthew Kacsmaryk, ruled in early April that access to mifepristone should be blocked while the case proceeds, indicating agreement with the plaintiffs’ arguments.
But that decision never took effect. The Department of Justice immediately appealed to the 5th Circuit, whose members instead said that mifepristone should be kept available while the case proceeds, but with restrictions: It would only be available through seven weeks of pregnancy, instead of through the first trimester, and would require three in-person visits to provide. Health authorities including the FDA and World Health Organization endorse telemedicine as a safe way to expand abortion access, and the WHO recommends the mifepristone-misoprostol combination up to 12 weeks of pregnancy.
The Supreme Court blocked any changes to how mifepristone is distributed for the duration of this legal challenge. Subsequently, the court sent the case back to the Fifth Circuit, instructing it to hear the case and issue a ruling.
But the losing side will almost certainly appeal the case to the Supreme Court, meaning that abortion could once again be in front of the nine justices as early as this fall. It would be the first abortion-related case to be argued by the high court since it overturned Roe v. Wade last summer.
This story was originally published by The 19th