Women across the U.S. may soon be unable to obtain one of two drugs typically used to induce medical abortions because of a high-stakes court case seen as the next step in the fight over abortion access.
A U.S. federal judge in Texas heard arguments Wednesday morning from the U.S. Food and Drug Administration (FDA) and an anti-abortion group that argues the FDA was wrong to approve mifepristone over 20 years ago.
The drug, along with misoprostol, can be taken by women at home and together they form the two-drug combination known colloquially as the abortion pill, which is used in just over half of all abortions in the U.S.
At Wednesday’s hearing, lawyers for the group Alliance Defending Freedom acknowledged it would be an unprecedented move for a court to revoke an FDA approval of a drug. But U.S. District Judge Matthew Kacsmaryk, a staunch conservative, also pressed the agency’s lawyers on whether it adequately reviewed safety concerns at the time and appeared open to the idea of an injunction against the pill.
If Kacsmaryk rules against the FDA, it could immediately shut down the sale of mifepristone as the lawsuit plays out in the upper courts — a process that will lead to years of uncertainty.
“This is a terrible attack on abortion rights and the spreading of misinformation on a pill that is a gold standard by the World Health Organization, a pill that many, many people use in the U.S. and in Canada,” said Farrah Khan, executive director of Action Canada for Sexual Health and Rights.
What is mifepristone?
Mifepristone dilates the cervix and blocks the action of the hormone progesterone, which is vital to continuing a pregnancy. Misoprostol causes contractions that empty the uterus. Typically, mifepristone is taken by mouth first, followed by misoprostol a day or two later.
Decades of studies show medication abortions are safe and effective, with a 95 to 99 per cent success rate around the world.
Although research shows misoprostol taken on its own is also highly effective and safe — the single-dose regimen is common in other parts of the world where mifepristone is scarce — it can be slightly less effective and more painful than the two-dose regimen.
When the FDA approved mifepristone in 2000 it placed several safety restrictions on its use, including limiting dispensing to specialty clinics and requiring women to pick up the drug in person.
After the U.S. Supreme Court overturned Roe v. Wade last year, the Biden administration sought to expand access to medication abortions, including allowing for the pill’s access through retail and mail-order pharmacies.
In late 2021, the FDA eliminated an in-person requirement for getting the pill, saying a new scientific review showed no increase in safety complications if the drug is taken at home.
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But several limitations remain, such as one that doctors must be specially certified to prescribe the drug.
Restrictions already exist
Since the fall of Roe v. Wade, 14 states have fully or nearly banned surgical abortions, making medical abortions a last resort for millions of Americans. Other states have pushed to enact their own bans as well.
“People are using access to the medical abortion pill to be able to circumvent what is happening in their states, to be able to get access to it,” Khan said.
But those states and others are moving to clamp down on medical abortions as well — particularly pharmacies’ ability to provide the drugs through the mail.
Last month, attorneys general in 20 conservative-led states warned CVS and Walgreens in a letter that they could face legal consequences if they sell abortion pills by mail in their states.
In response, Walgreens said it will not dispense mifepristone in those states and it doesn’t plan to ship the drug to them either. The company is not currently dispensing the pills anywhere but is working to become eligible through the FDA’s certification process to dispense the pills where it can legally do so, a spokesperson said.
CVS has not responded publicly to the letter and did not respond to a request for comment.
What was heard in court on Wednesday?
The Alliance Defending Freedom, which brought the lawsuit, was also involved in the Mississippi case that led to Roe v. Wade being overturned.
One of the alliance’s chief arguments against the FDA is that it misused its authorities when it originally approved the pill.
The FDA reviewed the drug under its so-called accelerated approval program, which was created in the early 1990s to speed access to the first HIV drugs. Since then, it’s been used to expedite drugs for cancer and other “serious or life-threatening diseases.”
The alliance argued that pregnancy is not a disease and therefore mifepristone should not have been considered for accelerated approval.
“The contrast between these illnesses and the FDA jamming pregnancy into … the FDA regulations could not be more stark,” alliance attorney Erik Baptist told Kacsmaryk.
But the FDA says the group’s argument is flawed on multiple counts. First, FDA regulations make clear that pregnancy is considered a “medical condition” that can be serious and life-threatening in some cases.
Second, while the FDA reviewed the drug under its accelerated approval regime, it didn’t expedite the drug’s review. In fact, approval only came after four years of deliberation. Instead, the FDA used regulatory powers under the accelerated program to add extra safety restrictions to mifepristone, including requiring physicians to be certified before prescribing it.
The FDA also says it carefully and extensively reviewed the scientific evidence showing the two-drug regimen is safe, with studies showing just a 0.4 per cent chance of major complications.
The Alliance for Defending Freedom has insisted it is not looking for a nationwide ban on medical abortions. Yet on Wednesday, Baptist told Kacsmaryk that “any relief you grant must be complete” and apply nationwide.
“The harms of these abortion drugs know no bounds,” he said.
Advocates fear Kacsmaryk, who has a history of siding with anti-abortion groups, will agree with the alliance’s arguments and rule in a way that severely limits access and causes spillover effects across the nation.
The judge appeared at times to be open to ruling in the alliance’s favour during Wednesday’s hearing. At one point, he told them that their outline for the order of their arguments “tracks the elements for an injunction nicely.”
Yet in an acknowledgment of the case’s significance, Kacsmaryk asked Baptist if he could cite a prior example of a court removing an FDA-approved drug after many years on the market.
Baptist acknowledged that there are no prior examples, but he blamed the drug’s longevity on the FDA’s “stonewalling” of his group’s prior requests to remove the drug. The group petitioned the FDA in 2002 and in 2019 seeking to curb access to the pill.
Kacsmaryk said he would rule “as soon as possible,” without giving any clear indication of how he might decide.
Should Canada be worried?
Khan says it’s too soon to say if Canada should brace for increased demand for the abortion pill from American women after Kacsmaryk’s ruling, which could come days or even months after Wednesday’s hearing.
Khan adds the lawsuit and its potential ripple effects are a reminder that Canada still has work to do to improve access to abortion.
“What’s happening in the United States is horrible. It’s an attack on abortion access,” she said.
“But we in Canada can do much more to ensure that people have the right to access to care, especially in northern, remote and rural communities.”
In Canada, mifepristone and misoprostol are sold together under the brand name Mifegymiso, which was approved by Health Canada in 2015 and became available to patients in 2017.
It can be taken up to the 10th week of pregnancy and sexual health experts have said greater use of the abortion pill in Canada can help free up surgical resources for people who may not have had access to reproductive care earlier in their pregnancy and may need surgical abortions.
Although doctors are able to prescribe the pill over the phone and pharmacies can deliver it, not all pharmacies carry it due to either its cost or owners’ moral beliefs.
Late last year, a shortage of Mifegymiso left women and girls in a lurch for over two weeks after its manufacturer, Linepharma, said multiple manufacturing issues came to a head “simultaneously.”
Khan says Ottawa can do more to improve access and education on the safety and efficacy of medical abortions to counter the rise of anti-abortion rhetoric and policymaking in the U.S.
That includes funding the Health Canada Sexual Reproductive Fund beyond 2024 and launching the sexual and reproductive health education portal the Liberals promised during the last election.
Earlier this month, Ottawa again said it would claw back federal health funding for provinces charging patients fees for health care, including abortion access, that is medically essential and should be publicly funded.
“There’s a lot of things we can do,” she said, adding that provincial politicians should also be pressed to stand up for further abortion and reproductive health access.
“We can’t just sit on our laurels and say, ‘Well, we’re not the United States.”
— with files from Rachel Gilmore and The Associated Press
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