‘Abortion pill’ under legal scrutiny; what it means in Michigan.

• The drug, mifepristone, was FDA-approved in 2000, and it blocks the hormone progesterone leading to a breakdown of the lining of the uterus and the pregnancy cannot continue. 
• It’s used with a second drug, to trigger nearly all of Michigan’s medical abortions. There were more than 15,000 such abortions in Michigan in 2021.
• In what could be a seismic legal precedent, a Texas judge has been asked to throw out the FDA’s approval of the drug, which has been legally available for years.

State and national abortion providers say medical abortions can continue — but possibly at a less effective rate, even if a Texas judge strikes down a long-time FDA-approved pill now used in nearly every medication abortion. 

At issue are two drugs, commonly known together as the “abortion pill.” The drugs are mifepristone and misoprostol.

In November, a coalition of groups and doctors who oppose abortion filed suit against the FDA and the U.S. Department of Health and Human Services, contending that the FDA  “failed women and girls when it chose politics over science” by approving the drugs for what the doctors call “chemical abortions.”

Related:

• Nov. 21, 2022: A Texas lawsuit could stifle Michigan access to the abortion pill
• Nov. 9, 2022: Abortion locked into Michigan constitution. What comes next.

Federal Court Judge Matthew J. Kacsmaryk, of the Northern District of Texas, a Trump appointee, could rule in the coming days on several questions raised by the plaintiffs, including the Alliance for Hippocratic Medicine, a newly formed coalition of doctors’ groups opposing abortion.

Plaintiffs through their lawsuit are trying to rescind the approval of the first drug in the series and to stop the second medication, which has multiple uses, to be used for the purpose of abortion.

Kacsmaryk, who has criticized Roe v. Wade in the past, also could issue a preliminary injunction to take mifepristone off the market, at least temporarily while the case proceeds through trial.

The case is unprecedented – a court has not ever before asked the federal government to rescind drug approval for a drug that has been available for decades – and Kacsmaryk’s decision could have wide-ranging implications for states, like Michigan, where abortion is still legal. 

Here’s what Michiganders should know as the case is decided:

What is mifepristone?

First approved 23 years ago, the first of the two drugs commonly used in abortions is mifepristone, known as RU-486. It’s sold under the brand name Mifeprex, and 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.)

The drug combination is used in more than half of abortions in the United States and in Michigan. In 2021, 15,367 abortions in Michigan, just more than 51 percent, were “medical,” or nonsurgical, according to the Michigan Department of Health & Human Services.

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.”

What, precisely, is the judge ruling on?

In their 133-page lawsuit, groups of doctors opposing abortion as well as four individual doctors argue the FDA didn’t adequately evaluate the drug’s safety specifically for abortion care and that it followed the wrong process for approval. 

Plaintiffs also contend that a 2021 policy shift that allows mail orders of the drug violates an anti-obscenity law known as the 1873 Comstock Act, which, among other things, bans the shipment of products “designed, adapted, or intended for producing abortion.”

Kacsmaryk also must decide whether the plaintiffs even have legal standing to bring the lawsuit. The doctors have argued they have been harmed because they’ve had to treat patients with complications, such as bleeding, from the pill regimen, according to reporting by the New York Times.

What does that mean for Michigan abortions?

First, with the approval last year of Proposal 3, abortion remains a constitutional right in Michigan.

But in his line of questioning, Kacsmaryk hinted at the possibility of an unprecedented order to force the FDA to withdraw its approval of the drug. 

But it’s unclear what that would mean. A court hasn’t ordered the unwinding of an FDA approval before, and that doesn’t necessarily mean the drug would be banned.

The National Abortion Federation, the professional association of abortion providers, has been working with providers, advising them to use a “misoprostol-only” regimen if mifepristone becomes unavailable since it has been licensed specifically for the two-drug abortion regimen, Dr. Alice Mark, NAF’s interim medical advisor, told Bridge.

She said the “misoprostol-only” regimen for abortions is commonly used elsewhere in the world. Because misoprostol would be available for other uses, U.S. doctors could continue prescribing it “off-label” for abortions.

“It is an effective regimen and it's a safe regimen,” she said. “The main downside is that it is slightly less effective and takes slightly more time to achieve a complete abortion.”

The two-dose abortion regimen is more than 99 percent effective at ending pregnancies, according to a 2015 study in the peer-reviewed medical journal, Obstetrics and Gynecology. But studies have found a misoprostol-only regimen much less effective — as low as 88 percent effective according to another peer-reviewed study.

Patients for whom the drugs are ineffective may require follow-up procedures or trips to the emergency room.

The evidence is clear: The two-drug regimen is safest and most effective, abortion providers say.

“It seems criminal to me that (abortion opponents) can go after the FDA to try to take a drug off the market that’s highly effective and extremely safe,” Renee Chelian, founder of the Detroit-area Northland Family Planning Centers, said, referring to the mifepristone.

What about the expanded access to the abortion pill?

Given the safety of the drugs for people who want to manage their own abortions at home, the Biden administration in January moved to expand the drug’s access through telehealth appointments. More specifically, the FDA removed the requirement that mifepristone was to be dispensed in person.

That allowed pharmacies that were willing to dispense the medication under certain conditions — they have to have the ability to track shipments, for example — to be able to dispense the pills for people with a prescription.

But the federal policy shift runs afoul of state laws. While abortion is now a constitutional right in Michigan, some states altogether ban abortion. And while some have argued that states can’t ban drugs approved by the FDA, Wyoming this week did precisely that, outlawing the use of any drugs used for abortion.