Abortion clinics are preparing to administer just one pill, misoprostol, to terminate pregnancies if a federal judge’s ruling goes into effect suspending the Food and Drug Administration’s approval of mifepristone, the other drug used in a medication abortion.
U.S. District Judge Matthew Kacsmaryk ruled Friday in Texas that the FDA ignored safety concerns and did not follow proper protocol when it approved mifepristone in 2000. But he gave the Biden administration a week to appeal his decision before his mandated pause on distributing the drug goes into effect.
The Justice Department asked an appeals court Monday to block the ruling.
NBC News spoke with 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 curtailed.
More than half of women who terminate their pregnancies in the U.S. do so via medication abortion. Research has shown that the standard two-pill regimen — mifepristone followed by misoprostol —has a 0.4% risk of major complications.
Most clinics said they plan to recommend misoprostol off-label to patients (the pill is approved only for abortions in combination with mifepristone). But misoprostol may be less effective when taken alone, and it may result in more intense side effects, such as nausea, diarrhea, chills, vomiting or cramping.
Deborah Vernon, the office manager at Woman to Woman Gynecology, an abortion provider in Las Vegas, said her office plans to give patients the option of surgical abortions or misoprostol on its own.
It expects an increase in surgical abortions, she said.
“We’ll have to change our office up somewhat so that we can set it up to be able to do more surgeries in a day. We may have to end up seeing patients every day of the week instead of just three,” Vernon said.
She added that the staff has been encouraging patients to schedule appointments right away since the lawsuit went before Kacsmaryk.
“We say: ‘Well, the options become more limited the longer you wait. It could be, as of next week, you may not even have this one 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.
A few states have announced such stockpiling efforts. Massachusetts directed health care providers to store a year’s worth of mifepristone, while Washington state ordered a three-year supply through the Corrections Department and secured an additional year’s supply through the University of Washington.
California separately negotiated the right to buy up to 2 million misoprostol pills to ensure continued access to medication abortion.
Could the FDA re-approve mifepristone?
Another potential option should Kacsmaryk’s decision go 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 not clear what that process would look like. Kirsten Moore, the director of the Expanding Medication Abortion Access Project, said it could take several years.
Moore said Danco Laboratories, the company that makes mifepristone, would first most likely need 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, a former FDA commissioner.
Kacsmaryk’s decision thrusts the FDA and drug manufacturers into “unknown territory,” she added.
Moore said that should Danco Laboratories submit a new application, approval wouldn’t come imminently— the review process alone could take at least 10 months.
“We could in reality be facing a scenario where this medication is only available in a clinical trial setting and not available to patients in the real world for upwards of two, maybe three years,” she said.
Although it might be possible for the FDA to approve mifepristone under a slightly revised indication, the agency declined to comment on its plans.
However, the appeals process is evolving quickly, and no U.S. court has overturned a long-standing drug approval before, so many questions remain about what is ahead. Kacsmaryk’s decision could be stayed as higher courts hear challenges, and it is likely to end up in front of the Supreme Court.
Conflicting decisions on abortion pills from 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, D.C., allege that the FDA’s current restrictions on distributing mifepristone unnecessarily hinder access. In that case, a district judge in Washington ordered the FDA to maintain the status-quo availability of mifepristone in the states that sued. His order came less than an hour after Kacsmaryk’s ruling and directly conflicts with it.
Abortion providers in states involved in the Washington lawsuit hope that case could safeguard their ability to administer mifepristone.
Roxanne Sutocky, the director of public affairs at The Women’s Centers, which operates abortion clinics in Connecticut, Georgia, New Jersey and Pennsylvania, said her network is “trying to communicate really clearly to our patients that they can keep their appointments.”
Trust Women, which operates an abortion clinic in Wichita, Kansas, is still scheduling appointments for two weeks out, said Zachary Gingrich-Gaylord, the organization’s communications director.
“The difficult thing, even given this ruling, is that it’s still somewhat unclear how to project what exactly will change, when it will change,” he said.
Vernon said providers at her office in Las Vegas expect to lose access to mifepristone.
“We have no faith in the system to take care of the women at all,” she said. “We’re not expecting much from any court — not from the judge, not from the 5th Circuit [the relevant federal appeals court], not from the Supreme Court.”
Source: | This article originally belongs to Nbcnews.com
