On April 21, 2023, the US Supreme Court ruled that the abortion pill mifepristone, which is used in more than half of all abortions in the US, may remain accessible without restriction – at least for now. The decision is temporary, however, as an appeals court is weighing the challenge against mifepristone brought by a Texas judge in early April 2023.
That ruling blocked the drug’s use in drug-induced abortions and attempted to remove it from the market altogether, questioning its safety. Days later, a US appeals court appeals lifted the suspension on mifepristone but placed stricter restrictions on it, including preventing it from being sent through the post.
The conversation asked twin sisters Jamie Rowenlawyer and obstetrician and gynaecologist Tami Rowen to put into perspective what the Supreme Court decision means for the advancement of access to the drug and how it came under legal scrutiny to begin with.
1. What led to the Supreme Court ruling on mifepristone?
In September 2022, several groups of anti-abortion doctors sued the Food and Drug Administration, arguing that they were harmed because the FDA’s 2000 approval of mifepristone was flawed and that the drug had not been adequately tested for safety, among other claims. The plaintiffs also claimed damages from the FDA’s 2016 and 2021 amendments that remove several restrictions on how the drug can be used or administered.
The doctors took the case to Texas, where a federal district judge ordered mifepristone to be withdrawn from the market while the case was pending.
The FDA appealed to the 5th Circuit, asking it for an emergency “stay,” or to uphold the district court’s order. The 5th Circuit ordered that while the case is being decided, mifepristone may be on the market, but only with the original restrictions from 2000. According to this order, mifepristone could only be used up to seven weeks of pregnancy and a personal visit was required. and prescription from a doctor.
The FDA, along with Danco Laboratories, the manufacturer of mifepristone, immediately asked the Supreme Court to suspend the 5th Circuit’s order. High Council stays are granted when at least five judges agree that the applicants — in this case the FDA and Danco — have a chance to succeed, among other things.
The majority did not explain its decision in favor of the FDA and Danco. The two disagreements — by Samuel Alito and Clarence Thomas — provide little insight into how the various judges might decide the case if they decide to review the forthcoming 5th Circuit opinion.
2. What comes next in the courts?
Due to the ruling of the Supreme Court, mifepristone remains available until a final ruling is made in this case. For now, the case will return to the 5th Circuit. Depending on the outcome of that case, either the plaintiffs or the defendants may ask the Supreme Court to hear the case. If the Supreme Court decides to hear the case, the final decision on whether to withdraw mifepristone from the market or impose stricter usage requirements will come from the Supreme Court. If not, the final decision comes from the 5th circuit.
Although the 5th circuit is scheduled to hear the case on May 17, 2023,, there is no fixed time frame within which it must make its decision. In short, it will probably take at least a year for the case to be decided. Regardless of these lower court decisions, the fact that at least five justices chose to stay the 5th Circuit’s emergency order suggests that the Supreme Court will want to make the final decision in this case.
3. What does this mean for future access to abortion?
The Supreme Court’s decision to maintain full access to mifepristone until the case is resolved leaves the FDA’s current rules in place. These rules allow mifepristone to be administered up to 10 weeks of pregnancy without an in-person visit to a clinic or hospital, by mail and by a certified pharmacy as an alternative to a doctor’s prescription.
Given the legal uncertainty and the amount of time it takes to complete a case like this, the Supreme Court decision of April 21, 2023 allows continued access to mifepristone for the foreseeable future. About 90,000 medication abortions are performed annually in the USthe vast majority of which rely on mifepristone as part of a two-drug regimen that also includes the drug misoprostol.
Mifepristone blocks the hormone progesterone, which is necessary to continue a pregnancy. Misoprostol, which is approved for use in the treatment of stomach ulcersalso causes uterine contractions and terminates the pregnancy.
AP Photo/Charlie Neibergall
If the final decision falls in favor of the plaintiff’s doctors, the consequences for pregnant people could be felt immediately. Taking Mifepristone off the market until the FDA makes safety findings sufficient in court, or restricting access to it through additional requirements, would lead people seeking medication abortions to use a misoprostol-only regimen or seek surgical abortions. Although it is safe and effective, the misoprostol-only alternative would cause higher rates of incomplete abortions requiring additional, usually surgical, intervention. These procedures would exacerbate the harm to those who choose or undergo abortion, including risks for subsequent pregnancies.
Similarly, forcing people to delay their abortions poses numerous health risks. Even Supreme Court justices are ambivalent about legal rights to abortion expressed a wish to have abortions take place as early as possible.
Restricting access to mifepristone may have additional harmful effects. Mifepristone also helps women complete a miscarriage much higher success rate than standard medical regimens that do not use mifepristone, sparing the risk of surgery and complications if the pregnancy remains in the womb.
For now, the Supreme Court has created a buffer to help mitigate such obstacles and adverse events while the lower courts, and probably the Supreme Court itself, decide the case.
4. What are the implications for other drugs?
The Supreme Court has not explained whether it thinks the plaintiffs will succeed in their argument that the FDA should not have approved mifepristone in 2000 or changed the rules surrounding its use in subsequent years.
When questioned by an administrative agency, such as the FDA, a court questions whether the arrangement was “arbitrary and capricious.” The 5th Circuit agreed with the court that the 2016 rule change was arbitrary and capricious because there was no study showing the effects of lifting multiple restrictions on the medication at once. The FDA has reviewed that multiple studies showed the lifting of these individual limitations was indeed safe for those taking mifepristone.
Questioning the agency’s scientific resolve in this way tests the nuts and bolts of the FDA process and the certainty of the drug manufacturing market. This is especially true for drugs that may carry higher risks but can be life-saving for patients. Undermining the authority of the FDA can also be transferred to controversial drugs such as the COVID-19 vaccine or even the vaccine against human papillomavirus or HPVmost common sexually transmitted infection in the U.S. Given parents’ concerns about vaccine safety and the belief that making sex medically safer for young people encourages them to have sex, the HPV vaccine is has been subject to increased supervision from vaccine opponents about the safety record.
Leaders from all over scientific, pharmacological and business world have raised alarm about the implications of these decisions for approved drugs and drugs in development.
Finally, the legal squabble over mifepristone will no doubt affect ongoing research into the many potential uses of this drug beyond abortion. These legal challenges delayed the introduction of mifepristone decades ago in the US market and they keep getting worse studies on the potential of mifepristone to help prevent certain cancers, uterine infections and other diseases influenced by progesterone.
For now, the Supreme Court has delayed a decision that could dramatically change the regulation of drugs in the US
