The future of medical abortion, which accounts for more than half of abortions in the United States, is up in the air after a federal judge ordered the Food and Drug Administration to withdraw approval of the drug mifepristone, also known as RU-486. is in good condition. with drug abortion. If the ruling is upheld, such abortions will continue to be possible using alternative medications. Even in states where they are legal, they can be more difficult to obtain.
On Friday, US District Court Judge Matthew Kaksmalik of Amarillo, Texas, ruled that the FDA did not follow due process when it approved mifepristone in 2000. The Texas ruling should be upheld until April 13 and the approval of mifepristone should remain in place. If the court does not issue a stay by that date, DOJ has said it will appeal to the Supreme Court.
Also on Friday, U.S. District Judge Thomas Rice of Spokane, Wash., ruled in favor of 17 states and the Washington, D.C. Attorney General, urging the FDA to “stand by” and keep mifepristone on the market. said it should. His I. Glenn Cohen, a bioethics and legal expert at Harvard University, said he expects the Supreme Court to issue an emergency stay pending appeal. Given the nationwide impact of this case and the competing ruling, he hopes the court will expedite it and make a decision in the coming months.
What does the ruling challenging the approval of mifepristone address?
Kacsmaryk’s ruling was based on Hippo, an anti-abortion organization and a group of physicians who argued that the FDA ignored reports that patients were harmed by mifepristone and did not follow proper procedures to approve mifepristone. Issued in response to a lawsuit filed by the Critic Medical Alliance. 20 years ago.
One complaint states that mailing mifepristone after a virtual visit with a doctor violates the Comstock Act of 1873, which prohibits sending “obscene” material by mail. His April 11 survey by the Planned Parenthood Association, a nonprofit organization in abortion and contraceptive science, found that the number of telemedicine abortions increased 137% between April 2022 and December 2022. I understand. If mifepristone’s approval is completely revoked, mailing it is moot, said Alina Sarganikov, director of women’s health policy at the nonprofit Kaiser Her Family Foundation. says.
The second complaint addresses the FDA’s approval system, which originally limited the prescription of mifepristone to hospitals, and contains other restrictions. The lawsuit alleges that the FDA used this approval mechanism to improperly and rapidly track drugs. However, these restrictions were superseded in 2011 by a new FDA regulatory system, which was updated in 2016 to allow telemedicine prescribing.
The third complaint is likely to have the greatest impact on drug policy. Plaintiffs argue that FDA approval and his delay in responding to complaints filed by anti-abortion advocates in 2002 were “arbitrary and capricious,” and that evidence of mifepristone’s safety and efficacy was insufficient. It is said that The FDA issued an interim response in 2003 and a final response in 2016, ultimately denying the complaint based on extensive evidence about the drug’s safety. The lawsuit alleges that this response was too slow and violated the agency’s own rules.
The idea that a district court could overturn the FDA’s decision worries pharmaceutical companies and medical professionals. “This opens the door for pursuing vaccines, gender-affirming care, and any drug that is considered controversial,” Sarganikov says. The FDA has a process for revoking drug approvals and has revoked more than 200 times since February 2018. However, Salganicoff said the decision was always based on the accumulation of evidence and reports of harm, rather than the decision of a single judge.
On Monday, more than 400 pharmaceutical company executives released a letter saying Kacsmaryk’s decision “sets a precedent for reducing the FDA’s authority to approve drugs, resulting in uncertainty across the biopharmaceutical industry.” Announced. They added, “If a court can overturn drug approval without considering the science and evidence, any drug risks the same outcome as mifepristone.”
“This concern is well-founded,” says Patricia Zetler, a health law expert at Ohio State University. States have tried to ban the drug in the past. No federal judge has ever done so, saying, “This is truly unprecedented.”
Is Mifepristone safe?
The Kacsmaryk ruling cited a 2021 study that analyzed 98 anonymous blog posts submitted to a website called AbortionChangesYou.com, of which only 54 were included in the analysis. The study found that 14% of the women who took part in the study said they had been inadequately informed about the physical and emotional side effects of medical abortion, but they were not aware of these effects. I didn’t measure it directly. Notably, 94% of her women said abortion was the only or best option in their situation.
Over 100 long-term studies have found mifepristone to be as safe as surgical abortion and have far fewer side effects than many other FDA-approved drugs. Also very effective. When mifepristone and misoprostol (the typical regimen for medical abortion in the United States) are used together, less than 5% of people need surgery to complete an abortion. The FDA considered this evidence when it rejected a public petition for mifepristone in 2016.
Kari White, director of the Texas Policy Evaluation Project at the University of Texas at Austin, said: The lawsuit “seems like a way for anti-abortionists to try to limit people’s ability to receive abortion care, even in states where abortion is legal,” she says.
What are my options if my approval for mifepristone is revoked?
Many providers plan to transition to misoprostol alone. Currently, medical abortion in the United States consists of two components: mifepristone, which terminates the pregnancy, and misoprostol, which expels the embryo or fetus from the uterus. Misoprostol itself can induce abortions and is used as such in many countries around the world. However, the drug is slightly less effective without mifepristone. People using misoprostol alone may need surgery to complete the abortion, and are more likely to experience moderate side effects such as nausea and heavy bleeding. said that while misoprostol is a viable option, “eliminating safe drugs [like mifepristone] The market approach is inconsistent with how healthcare is practiced in the United States. ”
Nonetheless, many clinics are preparing to switch dosing regimens if approval for mifepristone is temporarily or permanently withdrawn. In anticipation of such a ruling, the state said it would stockpile two million doses of misoprostol.
The Texas ruling does not mention misoprostol, as it is likely also used to treat miscarriages, ulcers, and other conditions. (Mifepristone is also sometimes used to treat miscarriage.) Banning the use of misoprostol in abortions is difficult because doctors can prescribe it “off label,” Cohen said. Also, it would be difficult to enforce a law prohibiting the mailing of this drug.
How might the Supreme Court rule?
Cohen said the U.S. Supreme Court has the option to uphold all three complaints, a combination of them, or none. The easiest way, he said, would be to dismiss the lawsuit, saying that the plaintiff lacks “legitimacy,” meaning that he was not personally harmed by mifepristone’s endorsement. legal scholar and his DOJ say the position’s arguments are weak. In the Hippocratic Medical Union lawsuit, the plaintiffs, representing patients who may have been harmed, said that terminating the pregnancy had damaged the lives of doctors and medical associations.because it’s a group Caring for a patient suffering from the side effects of medical abortion can separate you from other patients. And plaintiffs argued that the FDA’s approval forced alliance groups to spend more time and money “educating” their members “about the dangers of abortion drugs.” But the DOJ says the plaintiffs’ doctors and associations don’t even prescribe mifepristone, so giving them status allows any doctor to challenge approval of the drug for any reason. .
*Editor’s Note (4/12/23): This sentence was edited after posting to correct a description of an attempt to ban the sale of Zohydro in Massachusetts in 2014.
