With four days to go until a federal ruling could pull a widely used abortion pill off the market, Vermont abortion providers are making hasty plans to continue providing medication abortions.
Late last Friday, U.S. District Court Judge Matthew Kacsmaryk — a Trump-appointee based in Amarillo, Texas — issued an unprecedented decision to revoke the Food and Drug Administration’s approval of mifepristone, a medication first approved in 2000 to terminate pregnancies and treat miscarriages. Should it stand, the decision will take effect Friday, banning the sale of mifepristone nationwide, including in states such as Vermont where abortion remains legal.
“At least until April 14, mifepristone remains safe, legal, and available throughout the country,” Planned Parenthood of Northern New England said in a statement Monday. “Planned Parenthood of Northern New England health centers in Vermont, Maine, and New Hampshire will continue to offer medication abortion using the mifepristone protocol until further notice.”
The University of Vermont Medical Center will also “continue to provide the safe and effective, evidence-based regimen of mifepristone and misoprostol while we wait for final guidance from the courts” — at least until Friday — spokesperson Annie Mackin told VTDigger by email Monday. The medical center also will continue to prescribe mifepristone to treat miscarriages in the meantime.
Medication is the most common, least invasive method to carry out an abortion. Of 1,227 abortions performed in Vermont in 2020, 926 were medication abortions, according to the Vermont Department of Health’s most recent Annual Vital Statistics Report. That accounts for more than 75% of abortions performed in Vermont in 2020.
In a typical medication abortion regimen, a patient first takes mifepristone, then a second pill, misoprostol. In other countries, it is common to only prescribe the second pill, misoprostol, to terminate a pregnancy.
FDA approval of misoprostol is not impacted by Kacsmaryk’s ruling, so Vermont abortion providers are preparing to turn to misoprostol-only abortions as soon as Friday, should Kacsmaryk’s decision take effect.
The one-pill regimen, though, has its downsides, according to Alison Bates, a nurse practitioner for Planned Parenthood of Northern New England. It is slightly less effective than the two-pill regimen — 85% to 95% effective, compared with 87% to 99% with two pills, according to Bates — which sometimes means a patient will need a follow-up treatment to complete the abortion.
And while the one-pill-only method still has a very low risk of serious complications, Bates told reporters at a press conference Monday it can be “less patient-friendly,” extending the duration and severity of side effects of the abortion.
“The side effect profile specifically is one of extended bleeding, of extended cramping and extended GI side effects, particularly nausea and vomiting,” Bates said. “And so you can already imagine with the expectation around bleeding and cramping, to have those symptoms or side effects happen for a longer period of time, it’s both unfriendly to the physical body, but also to somebody’s life circumstances and other responsibilities.”
When asked whether Planned Parenthood of Northern New England is prepared to make the switch to a one-pill regimen immediately — say, if doctors were directed to stop prescribing mifepristone at noon Friday, and a patient had an appointment at 1 p.m. — Bates said yes.
What Planned Parenthood of Northern New England won’t be doing, though, is stockpiling the medication. Liz Canada, from Planned Parenthood New Hampshire Action Fund, said they “don’t want to negatively impact other providers across the country.”
Even with contingency plans in place, the full image of what a post-mifepristone landscape could look like remains blurry. A federal judge has never before struck down FDA approval of a drug, as Kacsmaryk is seeking to do.
“This is completely uncharted territory,” Nicole Clegg of Planned Parenthood Maine Action Fund said Monday. “So when we think about what the outcome of this case could be — and the radical implications that it could have for the approval of any type of drug by the FDA if you have a political objection to it — I think that this should really be a wake up call and people should be incredibly upset and concerned about what could play out here.”
For several of reporters’ questions on Monday — less than one business day after Kacsmaryk issued his ruling — Planned Parenthood representatives had no answers.
For instance, if Kacsmaryk’s ruling takes effect Friday, what would happen to any pills already shipped to pharmacies and doctors offices? Could they be dispensed? Would they have to be thrown out? Would they be seized?
“I would say that is an open question,” said Lucy Leriche of Planned Parenthood Vermont Action Fund. Some could argue that whatever is already delivered to pharmacies would be fair game, she said, while others might make the case that distributing the medication would be illegal.
Even the Biden Administration is confused. On Friday, U.S. District Judge Thomas Rice of Washington state issued a ruling directly contradicting Kacsmaryk’s, in response to a lawsuit filed by 17 states and the District of Columbia seeking to expand access to mifepristone. Vermont Attorney General Charity Clark signed on to the suit.
Rice, an Obama-appointee, ordered that the FDA preserve the status quo and continue dispensing mifepristone, but his ruling applies only to the 17 states that filed the suit. And in a request for clarification filed Monday, the Biden Administration asked Rice to reconcile his order with Kacsmaryk’s, which would apply nationwide.
“The Court did not address the interaction between the two orders, presumably because they were issued less than 20 minutes apart,” the U.S. Department of Justice wrote to Rice on Monday.
The U.S. Department of Justice also on Monday appealed Kacsmaryk’s ruling to the conservative-leaning U.S. Court of Appeals for the 5th Circuit, and urged the court to pause Kacsmaryk’s order pending appeal. The DOJ, as well as mifepristone manufacturer Danco Laboratories, urged the appeals court to decide by noon Thursday whether Kacsmaryk’s order will take effect.
Later Monday, Clark and 23 other state attorneys general signed onto an amicus brief challenging Kacsmaryk’s decision and backing the DOJ’s request for a stay pending appeal.
According to Clark’s office, the 24 attorneys general “warn that revoking federal approval for mifepristone will drastically reduce access to safe abortion care and miscarriage management for millions of people across the country, endangering lives, and trampling states’ authority to protect and promote access to abortion.”
It is likely that the fate of mifepristone — and the greater question of whether a federal judge holds the power to revoke FDA approval of a drug — will eventually be determined by the U.S. Supreme Court.
Kacsmaryk’s decision marks the latest development in the legal battle over abortion rights since the U.S. Supreme Court overturned Roe v. Wade precedent in June, thereby ending the nationwide right to an abortion. In Dobbs v. Jackson Women’s Health Organization, the court’s conservative majority ruled that the question of abortion legality should go to individual state governments to decide.
But Kacsmaryk’s ruling, if it takes effect, would restrict access to the most common form of abortion nationwide, even in Vermont, where abortion remains legal and 77% of voters in November elected to enshrine abortion rights in the state constitution.
Mini Timmaraju, who is president of the national pro-abortion rights organization NARAL, said at a press conference Monday that “this was always the game plan” for anti-abortion advocates who have been working on the national level.
“They cannot pass a federal abortion ban. They’ve found no other way to prevent abortion access in states like Vermont,” Timmaraju said. “So this was always the game plan and always the type of strategy they’ve been pursuing for a long time through the courts.”
Kacsmaryk’s decision, Timmaraju added, indicates “an incredible threat to the democratic process.”
“States like (Vermont) that have enshrined abortion access in your constitution should be particularly alarmed at the way one activist judge and one organization … could get in front of this judge and have this type of ramification,” she said.
