Supreme Court ruling on mifepristone causes uncertainty for advocates
Activists on both sides of the abortion issue are awaiting a Supreme Court decision on the medication mifepristone, used in more than half of the abortions in the U.S. It is also used in miscarriage management.
How did we get here?
Mifepristone was called into question on April 7, when U.S. District Judge Matthew Kacsmaryk imposed a nationwide ban, saying the Food and Drug Administration (FDA) had improperly approved mifepristone 23 years ago. Within minutes, a judge in Washington state, U.S. District Judge Thomas Rice, issued a contrary ruling directing federal authorities not to make any changes in mifepristone access in at least 17 states where Democrats had sued to protect availability. Five days later, the 5th Circuit Court of Appeals narrowed Kacsmaryk's ruling. It declared that the time had passed for challenging the original FDA approval, but it also tightened the agency's window for using the drug from 10 weeks, as approved in 2016, to seven weeks.
The Biden administration asked the U.S. Supreme Court to preserve access to mifepristone. And the high court temporarily paused lower court rulings while setting the Friday deadline to decide whether to let any restrictions take effect.
Advocates cite one study to counter a green light from FDA
An attorney for an advocacy group that filed an amicus brief on behalf of parties suing for mifepristone restrictions argues that the drug declared "safe and effective" by the FDA is dangerous. Attorney Chelsey Youman, who represents Human Coalition, tells Morning Edition that despite 23 years of study and repeated reviews, the FDA has not fully accounted for possible complications.
In an interview with NPR's Michel Martin, Youman cites a single advocacy study of post-abortion emergency room visits that suggested an ER visit was more likely within 30 days of a medication procedure. "We're serving these women, sometimes in the middle of their abortions, calling us, panicking about what they're experiencing and what their bodies are experiencing," she says.
Since mifepristone was first approved by the FDA in 2000, the drug has been used for abortions by more than 5 million women in the U.S. A study from KFF, an independent health policy organization, determined that medication abortion successfully terminates pregnancy 99.6% of the time. The foundation found a .4% risk of major complications and a mortality rate of less than .001%.
The FDA issued its most recent summary report of adverse events in June 2022, saying it "did not identify any new safety signals."
Youman, whose group aims to eliminate abortion in the U.S., contends that the number of women requiring emergency follow-up care is "astronomical."
"That doesn't even include the FDA not requiring reporting of adverse events," Youman says, adding, "It's not safe for women."
Court rulings prompt anxiety and uncertainty
Dr. Audrey Lance, an OB-GYN with Northland Family Planning near Detroit, told Michigan Radio's Kate Wells that conflicting legal rulings and the wait for answers is complicating care and making it difficult to help patients.
"Am I allowed to do that? I don't know yet," Lance tells NPR. "I don't know what's going to happen."
Whether there's any consensus among justices on the high court is also unclear, as NPR legal affairs correspondent Nina Totenberg tells All Things Considered. "If there was a clear consensus on this at the court, I think the justices would have acted [earlier]."
Totenberg points to the early days of the pandemic, when some abortion rights activists were trying to ease restrictions on access to abortion pills. Then, conservatives on the Supreme Court deferred to the FDA's expertise. Justice Samuel Alito, who would later author the decision overturning the landmark Roe v. Wade abortion protections, expressed amazement in 2020 that a district court judge in Maryland "took it upon himself to overrule the FDA on a question of drug safety."
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Transcript
MICHEL MARTIN, HOST:
Abortion is again on the docket at the Supreme Court, this time over the widely used abortion pill mifepristone. The Biden administration is arguing to preserve access to the drug after a federal judge in Texas said it should be restricted. The Supreme Court is expected to weigh in today. Chelsey Youman is an attorney with Human Coalition. That's a group that hopes to end access to abortion throughout the United States and filed an amicus brief in the Texas case. Mrs. Youman, thanks so much for joining us.
CHELSEY YOUMAN: Happy to be here.
MARTIN: How are you feeling about today? As I said, your organization's goal - you're very clear about that - is to end abortion throughout the United States. Do you think that goal is in sight?
YOUMAN: You know, we at Human Coalition serve women every single day who are seeking abortion across the country. And we served about a quarter of a million women throughout COVID, really trying to help them get on their feet. And when we talk to them, 76% say they would prefer to parent if their circumstances were different. And so I think seeing a country where we as a society come alongside women instead of encouraging them to do the thing they don't want to do, which is actually...
MARTIN: OK.
YOUMAN: ...Have an abortion...
MARTIN: That wasn't...
YOUMAN: ...Is our goal.
MARTIN: OK. That wasn't my question, but we'll - we're going to move on. And let's just say for the sake of argument that the FDA was hasty 20 years ago when it approved mifepristone. That - they say they weren't. But let's just say for the sake of argument that they were. We've had 20 years of independent data not pushed by advocacy groups on either side that says it is safe. What is your legal argument for seeking a ban on mifepristone now?
YOUMAN: That is a great question. I'm so glad you asked it. Actually, in 20 years, the FDA did not require reporting adverse events besides death for the pill, so they actually have not proven up that it is safe and effective. Contrarily, there was a longitudinal study done that shows 35% of women who take the mifepristone end up in the ER within 30 days. It's dangerous. It causes hemorrhage. It's not as safe as a Tylenol. Tylenol doesn't cause rupture of membranes for ectopic pregnancies. We're serving these women sometimes in the middle of their abortions calling us, panicking about what they're experiencing and what their bodies are experiencing.
MARTIN: Well, I'm not going to argue with what people are calling you about because, certainly, I wouldn't have any access to that. But I have - I will say I read the amicus brief. And it is filled with statistics, which is, again, generated by an advocacy group like yours. And I would say from a journalistic perspective, we would not find that more - any more credible, more or less, than statistics generated by any advocacy group, including NARAL or Planned Parenthood. That being said, an independent researchers, the Kaiser Family Foundation, says medication abortion has a four-tenths of a percentage point risk of major complications and a mortality rate of less than 1,000 of a percentage point. The FDA says the risk of death by penicillin is four times greater.
And for a further point, tragically, childbirth in the U.S. is arguably far more dangerous for all women, especially for Black women. The most recent numbers we could find from the CDC said that the mortality rate among non-Hispanic white women in childbirth was 27 deaths per 100,000 procedures. For Black women, childbirth in the U.S was 70 deaths per 100,000 procedures. That's worse than Mexico. Given all of that, what is the argument that this is - that banning mifepristone actually makes women safer?
YOUMAN: Yes. The longitudinal study actually compared Medicaid data and ER visits and reporting from the doctors themselves across thousands and thousands of hospitals and women. And in that study, they found 35% of women end up in the ER with complications from the chemical abortion pill. That's astronomical when you think about it. And when you understand, as well, that that doesn't even include the FDA not requiring reporting of adverse events, it's not safe for women. You know, Tylenol doesn't cause hemorrhage. Tylenol doesn't cause sepsis.
MARTIN: And again...
YOUMAN: Tylenol doesn't produce a dead body, which - mifepristone does.
MARTIN: And again, that longitudinal study comes from an advocacy group like yours. And I think that's important to point that out - not an independent research group like Kaiser, etc.
YOUMAN: You know, one thing you need to know...
MARTIN: But before we let you go, tell us about...
YOUMAN: ...Is that two women in Louisiana actually have died since December. I spoke with the district attorneys, and so that's from pills that are coming internationally.
MARTIN: OK.
YOUMAN: It's a crisis out there for women. I think it's important for them to know that.
MARTIN: OK. Before we let you go, what court cases or legislation on the state or national level is your organization looking to support next? And we're particularly interested, as briefly as you can, if - what if the Texas judge's order banning mifepristone is overturned? What's the next move?
YOUMAN: Well, I think the next move, of course, as we are committed to serving pregnant women, is to be there for them, to be there as a safety net and to understand that children aren't disposable across the country, to be there to serve them and do that. And additionally, I think it's important to note that we want to be a voice for women whose voices aren't getting a platform. We're serving them. We know when they're traumatized, they - what they experience in their abortions, and we want to be there for them.
MARTIN: Chelsey Youman is an attorney with Human Coalition. That's an advocacy group that hopes to eliminate abortion in the United States. Chelsey Youman, thank you so much for joining us.
YOUMAN: Thanks for having me. Transcript provided by NPR, Copyright NPR.
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