The Texas lawsuit could not only further limit access to abortion in the United States, but also set a dangerous precedent for overturning the drug’s approval by the U.S. Food and Drug Administration (FDA).
following the inversion of egg v. Wade Last year, some US states banned abortion, prompting more pregnant people to seek medical abortion. A lawsuit against the FDA filed by anti-abortion groups and doctors seeks to overturn his 2000 FDA approval of the abortion drug mifepristone. Plaintiffs claim mifepristone is not safe when used in combination with another drug, misoprostol, a claim not supported by scientific evidence, researchers said says. NatureLegal experts believe that Judge Matthew Kaksmalik of the United States District Court for the Northern District of Texas is likely to rule in favor of the plaintiffs.Appointed by former U.S. President Donald Trump who promised to help overthrow eggKacsmaryk “has deep ties to religious rights, and he bases his ruling on a very conservative ideology,” says Amanda, an attorney and director of The Lawyering Project, a New York City-based organization. Allen said. Improve access to abortion.
The impact of this incident will spread across the country and may further affect the health care of pregnant women. “If plaintiffs get what they want, mifepristone will be banned in every state. It doesn’t matter if a state has laws protecting access to abortion,” Allen said. increase.
here, Nature We discuss the evidence in the case, what is at stake, and the abortion options available to people in the United States if the FDA loses.
Is Mifepristone Safe?
All evidence suggests the answer is yes, contrary to plaintiffs’ claims.His 2013 systematic review published in the journal contraceptionFor example, fewer than 5% of women had unsuccessful abortions with mifepristone and misoprostol, and only 0.3% were hospitalized after treatment.1The World Health Organization (WHO) lists this regimen as safe, as does the American College of Obstetricians and Gynecologists (ACOG).
Plaintiffs also allege that the FDA made a mistake when it approved the drug in 2000 and its generic version in 2019. Abortion drugs will have a “meaningful therapeutic effect”. “But pregnancy is not a disease,” plaintiffs said in their complaint.
In response to the lawsuit, FDA attorneys wrote that the approval of mifepristone did not include an accelerated review (the approval process took four years). They also said plaintiffs have not provided specific examples of patients who may have suffered serious adverse events related to mifepristone. That omission is particularly important given the history of the court,” the court filing said.
If the FDA loses, can people wanting abortions continue to use misoprostol?
The combination of mifepristone and misoprostol is the most commonly prescribed regimen for medical abortion in the United States, but both the ACOG and WHO agree that misoprostol alone is safe. It is said to be an effective alternative.
“Mifepristone has received a lot of attention because it was approved as an abortion drug,” says innovations in reproductive health access, a reproductive health and justice expert and nonprofit organization based in Emeryville, California. says Cali Siestra, Principal Consultant at It is designed to block progesterone, a hormone needed to sustain pregnancy. However, researchers noticed that the uterus contracts, bleeds, and expels the embryo inside.
So medical abortion is an option, says Heidi Moseson, an epidemiologist based in Oakland, California, who works at Ibis Reproductive Health, a global research organization that supports abortion rights. “U.S. clinicians just have less experience providing it, because combination therapy has been the default for so long,” she says.
Mosesson was the first author of a study published last year2 of The Lancet Global Health This investigated the efficacy and safety of medical abortion with misoprostol alone or in combination with mifepristone. The study, which followed 961 of his self-administered abortions in Argentina and Nigeria, found that 99% of those who used only misoprostol had complete abortions without the need for surgical intervention. got it. In patients using combination regimens, he had a rate of 94%.
Another reason misoprostol is often not given alone is that several clinical trials have shown low success rates with misoprostol, says Moseson. But that’s probably due to differences in study design and local conditions, she added. Recommended. This is registered as an unsuccessful use of the drug. Success rates tend to be higher in situations where surgical intervention is not readily available, says Moseson.
Another issue is that some of the previous studies that evaluated misoprostol alone did not use dosing regimens currently approved by WHO. “There’s a lot of variability in both results and the regimens used,” says Daniel Grossman, director of Advancing New Standards in Reproductive Health, a social science research group at the University of California, San Francisco.
Could misoprostol be eventually banned?
It is possible. In addition to calling for a ban on mifepristone, the Texas lawsuit invokes the Comstock Act of 1873, which is still part of US law. The law made it illegal to send obscene material or articles intended for the purpose of “abortion” by mail. The plaintiff’s legal team hopes to use this to prohibit the distribution of all abortion pills by mail.
“Their first objective in this case is to track down mifepristone. But make no mistake, the plan here is to end access to medical abortion for everyone in this country.” ‘ says Allen.
Court precedent overturning FDA approval by challenging FDA’s decision-making capacity endangers not only misoprostol, but many non-misoprostol drugs, including oral contraceptives and COVID-19 vaccines may be exposed.
“This really threatens the FDA’s authority over the entire drug approval process,” says Allen. “It’s the FDA that has the scientific and medical expertise to make these decisions, not the courts, so it’s really kind of silly in the face of the idea that the FDA is there.”
what happens next?
Kacsmaryk may make a decision later this month. What happens after that is up to the judge. If he agrees with the plaintiff, he could trigger an immediate ban on mifepristone or order the FDA to take specific action. In the latter case, “Nothing really happens until these steps are taken, so we’re just waiting and seeing,” says Allen.
According to Allen, if such a decision were to be appealed, it would be appealed to the Fifth Circuit Court of Appeals, “one of the most conservative appellate courts in the country.” Assuming the court upheld this theoretical determination by Kacsmaryk, the next option is for the FDA to take the matter to the Supreme Court.
This article is reproduced with permission and was first published on February 23, 2023.
