A judge in the state of Texas is expected to rule as early as February 24 on whether to overturn US Food and Drug Administration (FDA) approval of mifepristone, an essential medication used in more than half of the abortions that happen through clinics and physicians’ offices in the US.
Abortion access advocates are raising the alarm, warning that the Texas judge, who was appointed by former US President Donald Trump, could single-handedly force the FDA to withdraw its approval of mifepristone, causing the drug to be removed from the US market.
Cat Duffy, a policy analyst with the National Health Law Program, said the judge has a range of options, including overturning FDA approval, eliminating access to the drug via telehealth but allowing access in-person, and dismissing the case.
“If the judge does rule to force the FDA to revoke its approval of mifepristone, then that will effectively ban the use of mifepristone nationwide, and that includes in states that have enacted rigorous protections for abortion access,” Duffy told Al Jazeera.
Abortion access has been curtailed across the US since the Supreme Court overturned Roe v Wade, which for nearly 50 years had protected abortion as a federal right. Its Dobbs v Jackson ruling last June said the US Constitution does not guarantee a right to abortion.
Mifepristone approved decades ago
In the US, there are two common abortion methods. Dilation and curettage, also known as D&C or surgical abortion, involves dilating the cervix and removing tissue from the uterus. Medication abortion, or “the abortion pill”, most often involves the combination of two medications: mifepristone and misoprostol. Mifepristone blocks hormones to end a pregnancy and misoprostol causes cramps to empty the uterus.
Medication abortion is a safe method that can be taken at home, and has helped promote access to abortion in rural communities.
The FDA first approved mifepristone in 2000. Medication abortions have increased steadily in recent years, and in 2020, this type of abortion accounted for 53 percent of abortions in the US that happen via facilities like clinics and physicians’ offices.
The lawsuit by the Alliance for Hippocratic Medicine, a coalition of groups that assert “abortion is not healthcare”, against the FDA alleges the agency improperly used accelerated drug approval for mifepristone, failed to study its safety, and ignored the potential hormonal effects on teenagers.
Alliance Defending Freedom counsel Julie Blake told Al Jazeera: “The FDA has been entrusted by Congress to serve as the nation’s gatekeeper of legal drugs but it failed its responsibility to protect the health, safety, and welfare of women and girls when it approved chemical abortion drugs and removed safeguards on their use.”
For example, the suit alleges the FDA extended the use of mifepristone from seven weeks to 10 weeks, which the group claims is unsafe.
“There’s been a tremendous amount of research that has been published and continues to consistently document the safety of this treatment,” said Daniel Grossman, professor in the department of obstetrics, gynaecology and reproductive sciences at the University of California, San Francisco. “In terms of hormonal effects on young people, there has not been any evidence to indicate that that’s a concern.”
He said medication abortion has a success rate of about 97 percent for pregnancies under 10 weeks. The remaining three percent of people will need an additional intervention to end the pregnancy.
Risk of severe bleeding, infection or death are rare: “Overall there have been 0.5 deaths per 100,000 medication abortions,” Grossman said. In about half those cases, the death wasn’t related to the treatment — the person died from homicide or an unrelated drug overdose, for example.
“It’s unbelievable that this case has gotten so far,” Grossman told Al Jazeera. “That a bunch of anti-abortion advocacy groups can essentially undermine the authority of the FDA through this legal action.”
What could the case mean for sanctuary states?
After the Dobbs decision, California passed laws to protect abortion access, resulting in a slight increase in abortions as people arrived from out of state, according to data from the Society of Family Planning.
Lisa Matsubara, vice president of Policy and General Counsel for Planned Parenthood Affiliates of California, said providers in her state are planning for the worst-case scenario.
“If that happens and it is actually implemented, in the sense that the FDA does pull approval of mifepristone … it will make mifepristone unavailable across the country, including in California,” she said.
In sanctuary states, abortion will still be legal if the FDA pulls mifepristone, but access to the pill would vanish overnight. “Just because abortion is legal does not mean it’s accessible,” Duffy said.
What could happen in states with abortion bans?
Since the Dobbs decision, Georgia has passed a six-week ban on surgical abortion, and droves of people are now travelling out of state, explained Dazon Dixon Diallo, founder of SisterLove, a sexual and reproductive health advocacy group in Georgia.
“They’re going to Florida, South Carolina, Kentucky, Illinois, DC, North Carolina,” she said.
Even if women can cover the cost of travel, they may not get an appointment “because these haven states are now overwhelmed”, Dixon Diallo said.
While medication abortion is still legal in Georgia, lawmakers are trying to limit access. The state now faces two direct threats to abortion pills — the Texas FDA case, and Georgia Senate Bill 456, which would require pregnant people seeking abortion-inducing medication to see a doctor in person, and would make it illegal to send the medication by mail.
If access to pills is curtailed, Dixon Diallo expects people will search online for pills that may not be the correct medication, and try to order them across state lines.
“You’re going to send it underground, you’re going to see [people seeking pills on the] black market, which also is going to increase criminalisation of certain people,” she said.
Can misoprostol be used alone?
If mifepristone is taken off the market, Grossman said misoprostol can be used alone to induce a safe abortion.
“The World Health Organization in its guidance clearly states that in settings where mifepristone is not available or accessible, that it’s very reasonable to use regimens that include just misoprostol.”
He said it is slightly less effective — about 85 to 90 percent effective.
Dixon Diallo said misoprostol-only abortions are not ideal. “It’s just not as effective,” she said. “And so that raises other questions about what happens when people have an incomplete termination — where they go, and not only that, but once they show up somewhere, and they were past six weeks, what does the provider do? Are they reported? Are they arrested or criminalised for that?”
Meanwhile in Texas, abortion is outlawed after a foetal heartbeat is detected, around six weeks, and people can be sued for helping a pregnant person access abortion. Auntie Network USA, a Facebook group that hosts a nationwide network of volunteer “aunties” who help “nieces” who are in need of abortions, has seen a surge of requests across the south and in other red states.
Lisa, the Texas-based co-founder of the network, asked that only her first name be published for legal and safety reasons. She said the network will continue to help people access abortion, even if the FDA overturns its approval of mifepristone. She has consulted with physicians on how misoprostol can be used alone.
“I am confident on how to instruct women to have a misoprostol-only abortion,” Lisa said. “So no, this decision will not stop Auntie Network USA from pushing forward and doing the work we do.”
