Abortion clinics are preparing to administer a single pill, misoprostol, to terminate pregnancies if a federal judge’s ruling suspending the Food and Drug Administration’s approval of mifepristone, the other drug used, goes into effect. in a medical abortion.
US District Judge Matthew Kacsmaryk ruled Friday in Texas that the FDA ignored safety concerns and failed to follow proper protocol when it approved mifepristone in 2000. But he gave the Biden administration a week to appeal its decision before he the mandatory pause in the distribution of the medication enters into force. effect.
The Justice Department asked an appeals court Monday to block the ruling.
NBC News spoke to abortion clinics in nine states — Connecticut, Florida, Georgia, Kansas, Maine, Nevada, New Jersey, North Carolina and Pennsylvania — about what they plan to do if their legal access to mifepristone is restricted.
More than half of the women Those who terminate their pregnancies in the US do so through medical abortion. Investigation has shown that the standard regimen of two pills (mifepristone followed by misoprostol) has a 0.4% risk of serious complications.
Most clinics said they plan to recommend misoprostol to patients off-label (the pill is approved only for abortion in combination with mifepristone). But misoprostol may be less effective when taken alone and may cause more severe side effects such as nausea, diarrhea, chills, vomiting, or cramps.
Deborah Vernon, office manager for Woman to Woman Gynecology, an abortion provider in Las Vegas, said her office plans to give patients the option of surgical abortions or misoprostol alone.
Expect an increase in surgical abortions, he said.
“We will have to move our office a bit so that we can prepare it to be able to do more surgeries in one day. We may have to end up seeing patients every day of the week instead of just three,” Vernon said.
He added that staff have been encouraging patients to make appointments right away since the lawsuit was filed with Kacsmaryk.
“We say, ‘Well, the options get more limited the longer you wait. It could be, starting next week, that I don’t even have this particular option,’” Vernon said, referring to mifepristone.
Several abortion clinics said they have stockpiled one to three month supplies of mifepristone to make sure they can administer it for as long as possible.
Some states have announced such storage efforts. Massachusetts ordered health care providers to stock mifepristone for a year, while Washington state ordered a three-year supply through the Department of Corrections and secured an additional year’s supply through the University of Washington.
California separately negotiated for the right to purchase up to 2 million misoprostol pills to ensure continued access to medical abortion.
Could the FDA reapprove mifepristone?
Another possible option if the Kacsmaryk decision goes into effect would be for the FDA to try to approve mifepristone again.
Given the unprecedented nature of the lawsuit and Kacsmaryk’s decision, it is unclear what that process would look like. Kirsten Moore, director of the Expanding Access to Medical Abortion Project, said it could take several years.
Moore said that Danco Laboratories, the company that makes mifepristone, would first likely have to discuss with the FDA what data would be required to support a new application.
It is not yet known whether the company would need to submit completely new clinical trial data or apply for mifepristone under a new indication, said Jane Henney, former FDA commissioner.
Kacsmaryk’s decision pushes the FDA and drugmakers into «uncharted territory,» he added.
Moore said that if Danco Laboratories submitted a new application, approval would not be imminent: the review process alone could take at least 10 months.
“In reality, we could be faced with a scenario where this drug is only available in a clinical trial setting and is not available to patients in the real world for more than two, maybe three years,” he said.
Although the FDA may approve mifepristone under a slightly revised indication, the agency declined to comment on its plans.
However, the appeals process is rapidly evolving, and no US court has struck down a long-standing drug approval before, so many questions remain about what’s to come. Kacsmaryk’s decision could be put on hold while higher courts hear challenges, and is likely to end up in front of the Supreme Court.
Conflicting decisions on abortion pills by two federal judges
Further complicating the legal battle is a second lawsuit filed in Washington state, in which attorneys general from 17 states and Washington, DC, allege that current FDA restrictions on the distribution of mifepristone unnecessarily hinder access . In that case, a district judge in Washington ordered the FDA to maintain the status quo on availability of mifepristone in the suing states. His order came less than an hour after Kacsmaryk’s ruling, and it directly conflicts with him.
Abortion providers in the states involved in the Washington lawsuit hope the case can safeguard their ability to administer mifepristone.
Roxanne Sutocky, director of public affairs for The Women’s Centers, which operates abortion clinics in Connecticut, Georgia, New Jersey and Pennsylvania, said her network is «trying to communicate very clearly to our patients that they can keep their appointments.»
The Trust Women, which operates an abortion clinic in Wichita, Kansas, is still scheduling appointments for two weeks from now, said Zachary Gingrich-Gaylord, the organization’s director of communications.
«The difficult thing, even with this ruling, is that it’s still not clear how to project exactly what will change, when it will change,» he said.
Vernon said providers in his Las Vegas office expect to lose access to mifepristone.
“We have no faith in the system to take care of women at all,” she said. «We don’t expect much from any court, or the judge, or the 5th Circuit. [the relevant federal appeals court]not the Supreme Court.»