Update: The following story was updated Apr. 13 at 12:21 p.m. to include Wednesday's court ruling.
Access to the abortion-inducing medication mifepristone hangs in the balance across the U.S. However, providers in Virginia say they will continue to supply the drug unless instructed otherwise by the U.S. Food and Drug Administration.
A panel of federal appeals court judges in Texas ruled late Wednesday that mifepristone can remain on the market ‚ but it reimposed some restrictions that the FDA had eased in recent years. The decision, which likely faces additional appeals to the U.S. Supreme Court, permits the medication to be used to end a pregnancy only up to seven weeks instead of 10. And it bars patients from receiving the medication by mail among other restrictions.
The FDA announced in 2021 that it would allow patients to receive mifepristone by mail following a virtual visit with a doctor. Virginians have been able to access the medication without an in-person appointment since October 2021.
Still, pro–abortion rights activists are also ensuring that medication-assisted abortions will be possible if mifepristone becomes unavailable. Virginia League for Planned Parenthood and many other providers would shift from the current regimen, two doses of mifepristone paired with misoprostol, to a misoprostol-only method.
VLPP, which provides about one-third of the state’s abortion services, said 65% of patients who choose to end their pregnancies receive the two-dose mifepristone regimen, which the FDA has approved until week 10 of pregnancy.
The misoprostol method requires patients to take at least 12 pills over a one-day period.
“There is some concern about some increased bleeding and cramping without being able to use [mifepristone] first for those medication abortions,” said Jamie Lockhart, executive director of Planned Parenthood Advocates of Virginia. “And so, some people may then choose to have abortion procedures instead. But we want to be clear that it’s incredibly safe and effective as well.”
Misoprostol is the medication that causes the negative side effects associated with a medication-induced abortion — including nausea, vomiting and diarrhea. VLPP says moving to a misoprostol-only regimen could triple those effects.
The U.S. Justice Department appealed a Monday ruling by a federal district court judge in Texas that pulled the FDA’s 22-year-long approval of mifepristone. The DOJ asked the 5th U.S. Circuit Court of Appeals to prevent the ruling from taking effect until the appeals process is exhausted, but a panel of Circuit Court judges instead ruled Wednesday that mifepristone may remain on the market with some restrictions. That ruling is set to take effect at the end of this week unless the U.S. Supreme Court grants DOJ's request for an emergency order to put any action on hold.
“For years, there’s been a political movement challenging children’s vaccines. And there are challenges to COVID vaccines, but rarely has anyone even tried to go to court to overturn an FDA decision,” said William Schultz, former FDA deputy commissioner. “Never has a court actually overturned an FDA scientific decision in approving a drug on the grounds that the FDA got it wrong. Never until this decision.”
Schultz, who was speaking during a virtual press conference Tuesday with abortion rights advocates and health care providers, said the decision could have a devastating effect on future drug and vaccine development.
“It means that in order to get a drug approved, companies will not just have to survive often hundreds of millions of dollars and years of testing FDA scientific review,” he said. “But then they’ll have to survive challenges in court which could be immediately or, as in this case, 20 years later.”
Virginia Sens. Mark Warner and Tim Kaine joined 238 other members of Congress in filing an amicus brief urging the 5th Circuit to stop the ruling from taking effect, writing that it “has no basis in law, threatens the Congressionally mandated drug approval process, and poses a serious health risk to pregnant individuals by making abortion more difficult to access, when access has already been seriously eroded in the aftermath of Dobbs v. Jackson Women’s Health Organization.”
The anti-abortion groups who sued the FDA argued the agency didn’t thoroughly study the drug and disregarded its complications.
The FDA reported that between 2000 and 2022, 28 women out of roughly 5.6 million died after taking mifepristone for medication abortion. However, the FDA noted those deaths didn't consider the patients' health status, other medical conditions or concurrent drug use.
There were 15,601 abortions performed in Virginia in 2019, according to the Centers for Disease Control and Prevention. Virginia allows abortions during the first two trimesters of pregnancy, or up to about 26 weeks, and the vast majority occur 15 weeks or earlier.
Patients in Virginia have been able to access the medication through the mail with a telehealth visit since 2021.
