Federal judges in Texas have delivered time and again for abortion opponents.
They upheld a state law that allows for $10,000 bounties to be placed on anyone who helps a woman get an abortion; ruled that someone opposed to abortion based on religious beliefs can block a federal program from providing birth control to teens; and determined that emergency room doctors must equally weigh the life of a pregnant woman and her embryo or fetus.
Now abortion rights advocates — galvanized by the reversal of Roe v. Wade — are girding for another decision from a Texas courtroom that could force the FDA to remove a widely used abortion pill from pharmacies and physicians’ offices nationwide.
The wide-ranging lawsuit, brought by a conservative Christian legal group, argues that the FDA’s approval process more than two decades ago was flawed when it authorized the use of mifepristone, which stops the development of a pregnancy and is part of a two-drug regimen used in medication abortions.
“The FDA has one job, which is just to protect Americans from dangerous drugs,” said Denise Harle, senior counsel with the Alliance Defending Freedom, part of a conservative coalition that brought the suit in federal district court in Amarillo, Texas. “And we’re asking the court to remove that chemical drug regimen until and unless the FDA actually goes through the proper testing that it’s required to do.”
A decision in the case was expected as soon as Friday. If successful, the lawsuit would force federal officials to rescind mifepristone’s approval, and manufacturers would be unable to ship the drug anywhere in the United States, including to states like California, Massachusetts, Illinois, and New York where abortion remains legal.
Abortion rights supporters and medical groups have pushed back on the lawsuit’s claims. Twelve leading medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, say medication abortion is effective and safe.
Indeed, decades of research show the risk of major complications from taking abortion pills is less than 0.4% — safer than such commonly used drugs as Tylenol or Viagra.
“We’ve got 23 years of data domestically that shows how safe medication abortion is, and it’s been used internationally for decades,” said Amy Hagstrom Miller, chief executive of Whole Woman’s Health, a medical organization with clinics in several states. “It’s much safer than somebody being forced to carry a pregnancy against their will.”
About 5 million women in the United States, federal data shows — and millions more across the world — have safely used abortion pills. They can be taken up to 10 weeks into a pregnancy and are also used by OB-GYNs to . All told, more than half of all abortions in the U.S. are a result of medication rather than a medical procedure, according Guttmacher Institute research.
Medication abortion involves taking two pills: mifepristone, which blocks the pregnancy hormone, progesterone; and misoprostol, which induces a miscarriage. Both drugs have long and safe track records: Misoprostol was approved in 1988 to treat gastric ulcers, with mifepristone earning approval in 2000 to end early pregnancy.
By filing its lawsuit in Amarillo, the Alliance Defending Freedom was almost guaranteed to draw U.S. District Judge Matthew Kacsmaryk, a President Donald Trump appointee who worked as deputy general counsel at First Liberty Institute, a conservative nonprofit advocating for religious liberty, before being confirmed to the federal judiciary in 2019.
Civil rights groups universally opposed Kacsmaryk’s nomination to the Northern District of Texas. U.S. Sen. Susan Collins, a Republican from Maine, said during the confirmation process that Kacsmaryk showed “alarming bias against LGBTQ Americans and disregard for Supreme Court precedents.”
“He’s made statements in opposition to reproductive rights, linking up reproduction to the feminist movement and making anti-feminist statements,” said Elizabeth Sepper, a law professor at the University of Texas-Austin, adding that the Supreme Court’s decision last summer in Dobbs v. Jackson Women’s Health Organization, which overturned Roe, allowed the suit against the FDA to proceed. “Prior to Dobbs, the right to abortion would have stood in the way of this lawsuit. But now the conservative legal movement feels empowered.”
The lawsuit is the latest effort by opponents of abortion rights to stymie the use of abortion pills, which many people seeking abortion prefer because it allows them to control their own health care and affords privacy for a process that involves cramping and bleeding, similar to a miscarriage.
“When you have medication abortion, part of the process happens at home. And a lot of people like that,” said Hagstrom Miller, of Whole Woman’s Health. “People can be at home with their loved ones and can sort of schedule the passing of the pregnancy around their work schedule or their child care schedule.”
Harle, however, said that the FDA used a provision to approve the drug that should be used only for medications that treat illness, and that pregnancy is not an illness, but a condition.
“They didn’t meet the standards of federal law,” she said.
Mifepristone’s approval was investigated in 2008 — during the Republican administration of George W. Bush — by the Government Accountability Office, a congressional watchdog, which found that the process was consistent with FDA regulations.
“It’s hard to think of a drug that’s been under more scrutiny than mifepristone,” said I. Glenn Cohen, a Harvard Law School professor and one of 19 FDA scholars who filed an amicus brief opposing the lawsuit. “We don’t think there’s a problem here statutorily or medically. It’d be very dangerous to allow a single judge sitting in Amarillo to essentially order a drug that’s used by many women in America off the market.”
But Harle said that no amount of scientific data would be enough to convince her that mifepristone should be on the market.
“I think chemical abortion does great harms to women and their unborn children,” she said. “And that’s what this lawsuit is really about.”
Abortion care providers like Hagstrom Miller are bracing for the ruling. “I think people know that what happens in Texas doesn’t stay in Texas,” she said. “Some of the most progressive states in the country will face restrictions if this lawsuit is successful.”
If that’s the case, her clinics and OB-GYNs across the country will be forced to use only misoprostol for miscarriage and early abortion care, something that will reduce the efficacy of the method: While taking the two pills together is 99.6% effective in terminating early pregnancy, misoprostol alone — although still extremely safe — is about 80% effective.
Hagstrom Miller also notes that side effects from misoprostol can be more intense, including nausea, diarrhea, and severe cramping and bleeding.
“And that matters, right?” she said. “People should have access to the highest level of medical care.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
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Denise Harle, senior counsel with the Alliance Defending Freedom apparently does not read the possible side effects of the drugs her doctor prescribes her, or listens to the side effects of drugs on commercials that dominate the nightly news.
This is not freedom, or liberties, folks. It is the exact opposite. This is complete control of women, from her brain (book banning) to her womb. Nothing else. This has nothing to do with saving lives, in fact, endangering women’s’ lives by removing healthcare.
Do you see these people going after gun control, when little kids, barely more than babies, are shot down in schools? No, not a peep. They want more guns, less background checks, and less training and no licensing. Instead, little kids will be deprived of learning about the world though books. Do you see these right to lifers providing homes for unwanted children? Again, crickets. Do you see these people barring children from safe places in schools? No, they take the signs down.
Are you one of these people?
Thanks so much, Laurel. . . as usual you are right on!
Don’t you find it beyond ironic that often the same people that are against abortion. . . and, now seemly against many other forms of birth control. . . are in tremendous fear of “being replaced” by those who are not lily white? My,my, my FOX brainwashing propaganda certainly can be so very short sighted!
There are those who want to control all sides of the political spectrum. Take away the rights of the liberals, by controlling their bodies and their loves, and controlling the right by providing them what to think, so they can stay in their comfort zones.
Shouldn’t it say
“One Texas Male…” will decide what women can do with their bodies?
This is beyond reprehensible. These pills are used for other things. I had to take one for a gynecological procedure, an endometrial biopsy. This ludicrous how one man can say with impunity that these drugs are prohibited. All you forced birthers, how many kids have you adopted this year? How many low-income single-mothers abandoned by a walking baby-making factory have you helped? How many women have become septic from miscarriages not treated with a D&C (which is an abortion)? How many lives ruined because you have to insert your bogus morality into the lives of others? You all have glass houses. Some of you sugar houses, which crumble with less effort. The gall of some people policing others bodies.
What if you men were told you couldn’t do anything about your prostates or your limp-member syndrome that requires Viagra? What about circumcision? What about testosterone supplements because you’re feeling less manly? What happens when you get breast cancer and you need your chests cut and skin and flesh removed? All of this is personal, health care, and many of it is gender care. So just stop already. Stop telling women what they can and cannot do. Stop telling people in general what they can and cannot do with their bodies. And don’t use the covid vaccine as an argument why you now should have say. It’s weak and about a first-grade level argument. Don’t use religion either as we, per that pretty important document, have freedom of religion which means any or all. That document also says separation between church and state so, no rules or laws should be made based on religious dogma that most of the practitioners don’t even follow.
Like the Duggar family and their revelation that one of them had a miscarriage so she and her doctor made the decision to have a D&C, which is technically an abortion. This is why abortion IS health care. Rich, white, affluent women always had access and will continue to have access to life-saving procedures, meanwhile women all across this country are facing possible indictments for miscarriages (at the very least police investigations into the why), carrying non-viable fetuses to term only to have them suffer for the few minutes they live outside of the womb before they die a horrific death while the parents watch, or women die because miscarriages aren’t properly treated and they go septic. What the hell is wrong with you people that can’t support the health and right of a woman?
This is what happens when Repubs are in control. My question is why do white men try to rule the lives of other people. They did this for years and still doing the same thing. Who left them in charge? I do believe some of his female family members are aborting children. The country we live in. Thank Gid the white msn is loosing his grip of control. People vote Republican this what they get.
Atwp: Dig a little deeper. There are black Republican politicians that support this ban on abortion. Some call it “black genocide.” Your prejudice shines through on nearly every comment you make, as you continue to be a victim either way the wind blows.
No matter how the court decides, this will be appealed all the way to the Supreme Court (SCOTUS).
As to drug safety, the pharmaceutical industry has a history of pushing drugs with questionable safety. Tylenol (acetaminophen) is a perfect example. It is the leading cause of acute liver failure in the USA. https://pubmed.ncbi.nlm.nih.gov/29199145/ It is so toxic that it has been used to poison Brown Tree Snakes in Guam. https://pubmed.ncbi.nlm.nih.gov/27604786/
Mifepristone and misoprostol are far safer than Tylenol. If this was about drug safety, it would be acetaminophen that would be on trial.
DaleL: You are correct. This has noting to do with drug safety, it is all about control. Drug safety is their angle.
I hate it when people kill snakes. Probably the most misunderstood creature on Earth. Thanks, Adam and Eve.
On Guam, the Brown Tree Snake is an invasive species and has no predators. It is a generalist and feeds on birds, lizards, and other animals. The snakes got to Guam after WWII. They eliminated most of the native forest vertebrate species. Considerable effort is made to insure that they do not get introduced onto other Pacific Islands, especially Hawaii.