- A conservative Texas judge invalidated FDA approval of mifepristone, one of two drugs used to induce abortions
- The ruling will surely spark an appeal and may end up at the Supreme Court
- The pill is used to cause half of all abortions. It remains legal in Michigan pending the litigation.
Michigan officials say medical abortions will continue in the state, despite a Texas federal judge’s ruling late Friday that suspended approval of the abortion medication mifepristone.
“Despite this ruling, I want to be clear: abortion, including medication abortion, remains safe and legal in the state of Michigan,” Gov. Gretchen Whitmer said in a written statement.
Whitmer nonetheless noted that “64 million Americans, including millions of Michiganders, may effectively be prevented from accessing the drug” if the ruling from U.S. District Judge Matthew J. Kacsmaryk stands.
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Kacsmaryk’s ruling invalidated the decades-old approval from the U.S. Food and Drug Administration of the so-called “abortion pill,” but he stayed his own order for seven days to give the agency time to appeal.
The ruling was further complicated when, according to the New York Times, another federal judge in Washington issued a separate ruling that ordered the FDA to make no changes to the availability of the drug.
Observers expect the U.S. Supreme Court to ultimately rule on the case.
It’s a case with huge implications nationwide and in Michigan, where mifepristone — in combination with another drug, misoprostol — is used in more than half of all abortions. In 2012, 51 percent of Michigan’s 15,367 abortions in Michigan were nonsurgical, according to the Michigan Department of Health & Human Services.
The uncertainty comes just months after Michigan voters overwhelmingly approved a constitutional amendment keeping abortion legal in the state — and in the same week that Whitmer signed legislation repealing an unenforceable 1931 law that made it a felony to perform an abortion in Michigan.
Bridge’s Robin Erb has written extensively about the abortion pill. Here are facts about the debate, taken largely from her March 22, 2023, article “Abortion pill’ under legal scrutiny; what it means in Michigan.”
What is mifepristone?
First approved 23 years ago, mifepristone is known as RU-486 and is sold under the brand name Mifeprex. The FDA approved a generic version (mifepristone) in 2019. The drug is the first half of the two-pill regimen to effect an abortion up to 10 weeks or so into a pregnancy.
Given first, mifepristone blocks progesterone, a hormone necessary to continue a pregnancy. Without progesterone, the lining of the uterus begins to break down, according to Planned Parenthood.
Taken up to 48 hours later, a second drug, misoprostol, starts contractions to expel the pregnancy tissue — much like a miscarriage.This second drug in the two-drug abortion regimen also is used to prevent stomach ulcers, and its users are warned that it causes miscarriages and is used to induce labor.
The FDA has approved the use of the abortion drugs through ten weeks of pregnancy, or 70 days or less since the first day of a patient’s last menstrual period. (Medical abortions are safe up to 12 weeks of pregnancy, according to the World Health Organization.)
Is it safe?
There’s plenty of data, but there’s still debate, too.
Some abortion opponents argue that mifepristone is unsafe, and unwinding its approval could — in Christen Polo’s words — “saves lives,” referring to not only fetuses but women.
Polo is the executive director of Protect Life Michigan, a group primarily of students and young people that opposes abortion rights. In an interview with Bridge, she noted that the FDA’s own data show “28 reports of deaths in patients associated with mifepristone since the product was approved in September 2000.”
“Anything that will save lives, even in the short term, I support,” Polo said.Two Canadian researchers earlier this year found adverse events from the drug are rare. Their research, however, did show that more women who got an abortion with the mifepristone–misoprostol combination up to 14 weeks pregnant faced complications compared to women who had a surgical abortion at about nine weeks, at least in certain circumstances.
In that study, researchers found that 3.3 per 1,000 women who had a medication abortion had complications such as an infection or bleeding that required a blood transfusion up to 42 days after their abortion compared to women who had a surgical abortion in a non-hospital clinic. In those clinics, 1.8 per 1,000 women had complications, they found.
The 28 deaths that Polo referred to were among 5.6 million women who have used the drug since its FDA approval in 2000, noted Dr. Sarah Wallett, chief medical officer for Planned Parenthood of Michigan.
Two of those deaths were from ectopic pregnancies. “Several” cases were from severe infections, or sepsis, according to the FDA.
And in the Canadian study, rates of complications from medication abortion were similar to those from abortions performed at hospitals.
In the Texas case, a brief filed by a dozen medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, lists dozens of sources and peer-reviewed studies supporting the drugs’ safety.
“Indeed, there is a greater risk of complications or mortality for procedures like wisdom tooth removal, cancer-screening, colonoscopy, plastic surgery, and the use of Viagra, than by any abortion method (medication or procedural),” the doctors said through a court brief.
In short, the data show “a more than 99 percent safety rate,” Wallett said
The lawsuit filed in Amarillo, Texas, to challenge mifepristone’s approval, she said, “is politically motivated. This is not science. This is not based on health.”
Who is the judge?
Kacsmaryk was appointed by former President Donald Trump and confirmed by a 52-46 vote by the U.S. Senate in 2019. His sister, Jennifer Griffith, told The Washington Post he is a longtime opponent of abortion who believes “he was made for this” decision.
CNN wrote that he has become a “chief antagonist of the Biden administration” on the bench, issuing rulings opposing efforts to expand LGBTQ protections and ensure minors have access to birth control without parental consent.
In his ruling on the abortion pill case, Kacsmaryk wrote that FDA violated federal standards when it first approved mifepristone 23 years ago.
“The Court does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”