Leaders of the American College of Obstetricians and Gynecologists (ACOG) and legal experts weighed in on the implications of a federal judge's decision to suspend the FDA's decades-old approval of mifepristone (Mifeprex), the most commonly used drug for medication abortion nationwide.
"Please understand that this judge's decision does not mean that medication abortion is not safe. It is safe, it is effective, and it should be an available option for all who seek abortion care," said Iffath Abbasi Hoskins, MD, president of ACOG, during a press call on Monday.
One consequence of the ruling by Judge Matthew Kacsmaryk, of the U.S. District Court for the Northern District of Texas -- which takes effect in 7 days, allowing the federal government time to appeal -- is that clinicians may be forced to offer options that are "safe," but "might be less clinically appropriate when managing abortion and miscarriage," Hoskins said.
"Frankly, as a clinician, I do not want to be in that position," she added.
Jennifer Villavicencio, MD, MPP, lead for equity transformation at ACOG, said that when the decision was issued on Friday, there was a "flurry" of text messages from other clinicians asking, "What does this mean for my patients on Monday? What does this mean for my patients tomorrow?"
"So, while the lawyers and the courts are going to be working this out, we are seeing patients every single day and having to make decisions about whether or not we're able to hand this medication over," she continued.
"Doctors are not lawyers," Villavicencio noted. Even lawyers are finding themselves in a situation that is "completely unprecedented" in which a judge has taken a stance against the FDA "in such a biased, such a harmful way."
Given that the situation is still unfolding, "ACOG will have to follow the FDA and the FDA's recommendations really closely," so as to ensure that physicians are adhering to the appropriate regulations for medication abortion, she said.
Misoprostol Alone
Asked about the safety of misoprostol used alone, Villavicencio said that it is "a safe and effective method for both miscarriage management, as well as induced abortion in the first trimester; however, it is not as effective as the two-drug regimen of mifepristone and misoprostol."
As to whether misoprostol could be taken without a clinician's supervision, she noted that there are "excellent data" on "self-managed abortion" when patients have the appropriate information.
Some of the most "significant side effects" seen with misoprostol are nausea, diarrhea, and vomiting. Swallowing the pill carries the highest risk of such side effects, Villavicencio said. Mucosal absorption -- either in the check, rectum, or vagina -- decreases the risk, although it does not eliminate it.
One serious risk in the current reproductive landscape is that if a patient does end up requiring medical care, that patient may be subject, in some states, to "criminalization or ... legal scrutiny as a result," Villavicencio added. She noted that far from being hypothetical, this is an occurrence that ACOG has seen play out in states that are attempting to or have restricted abortions.
Whether the judge actually has the power to upend access to medication abortion or not, he has already influenced care through the "inappropriate" and "harmful" language used in his decision, which is certain to have a "chilling effect" on the way physicians interact with patients, Villavicencio said.
In an email to MedPage Today, Kate Connors, ACOG's director of communications and public affairs, wrote that there has been no immediate change in the organization's guidance related to mifepristone.
"As of this moment, mifepristone remains available and remains part of the ACOG-recommended regiment for medication abortion up to 70 days and miscarriage management," she noted.
As for the possibility of guidance from ACOG, Connors said the organization can't commit to a timeline without knowing what will happen this week. However, ACOG does plan to release national guidance to its members once it has the information needed to do so.
Susan Polan, PhD, associate executive director of public affairs and advocacy for the American Public Health Association (APHA), who was not on the press call, also weighed in.
"I think there's so much that's still unknown, particularly with the conflicting lawsuits ... there's the Washington state ruling [that could take precedence] and then in every other state, it's the Texas ruling. And so there obviously needs to be some sort of national decision on this," she said.
Within an hour of the Texas ruling on Friday, a federal judge in Washington announced a competing decision directing the FDA to preserve access to mifepristone in 17 Democratic-led states and the District of Columbia, attorneys general of which brought the lawsuit against the agency to preserve access to the drug.
The fact that mifepristone has been available for 23 years, been deemed safe and effective, and been used by more than 5 million women needs to be communicated to the public, Polan noted.
"So, if this drug with this record that is this important to the health of women and people of childbearing age" can have its approval questioned, "then what's next ... where's this all going to go?" Polan asked.
On Monday, the Department of Justice (DOJ) asked the Fifth Circuit Court of Appeals before the Texas decision takes effect.
"If allowed to take effect, the court's order would thwart FDA's scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity," the DOJ said.
Joyce Frieden, MedPage Today's Washington Editor, contributed to this story.
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