One Texas Judge Will Decide Fate of Abortion Pill Used by Millions of American Women

Yves here. Aiee, I somehow missed that this case contesting the FDA authorization of mifepristone, an abortion drug that works by blocking progesterone, which then leads to the breakdown of the lining of the uterus.

I wonder if the FDA can finesse the apparently unduly thin safety approvals on the original drug with it later approval of the generic, which relied on extensive safety data from usage. In other words, the brand name version gets knocked out but not the generic.

This article skips over the fact that being restricted to using only the second pill in the 1-2 chemical abortion cocktail, misoprostol, which effectively induces a miscarriage, could potentially be blocked down the road by an omnibus spending bill that includes a provision that allows the FDA to block “off label” uses of approved drugs. Misoprostol is not approved for inducing abortions except in combination with mifepristone. It’s not hard to imagine the FDA in a Republican administration barring that application.

Separately, I also wonder why reproductive freedom advocates are not regularly reminding women to use morning after pills, which are available OTC, if they’ve had unprotected sex and are not trying to become pregnant.

By Sarah Varney, Kaiser Health News Senior Correspondent, who regularly produces segments for PBS NewsHour and has had stories publised in The New York Times, The Washington Post, the Los Angeles Times and KHN’s other print partners. Originally published at Kaiser Health News

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 manage early miscarriages. 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.”

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  1. timbers

    Wish American judges exercised the same robust willingness to strike down more blatant unconstitutional law like the Patriot Act, as they do striking down abortion rights related legislation.

  2. Dale

    Over the rest of the twenty-first century, one country after another, where abortion is now legal, will outlaw abortion and access to birth control, or at least strictly limit it. At current birth-rates, the human race will go extinct in a few hundred years. Governments around the world will act to try to prevent this from happening.

    1. Yves Smith Post author

      Please do not make wild, unsubstantiated claims. The trends globally are in the opposite direction. That is reflected in the widespread condemnation and shock in foreign media at the US taking such retrograde action.

      The abortion restrictions in the US come from concerted efforts by evangelicals. Europeans countries by and large made their compromise with the Catholic Church by restricting most abortions to the first trimester. African countries, which score far and away highest as “feel religious” (see have been moving towards, not away, from more access to abortion:

      In 1994, abortion was completely prohibited in 17 African countries, and was only legal if saving a woman’s life in a further 15. In 2022, these two numbers stand at 6 and 13. A total of 19 countries have improved their abortion laws to some significant extent since 1994.

      India, which scores very high on religious impulses, has recently strengthened the right to abortion. Saudi Arabia, also high in that category, had better access to abortion than Alabama pre the Roe v. Wade rollback: The Soviet Union was first to legalize abortions and there is no interest in Russia to change that. Etc.

      1. Dale

        It all depends on how much society values or needs the next generation. Over the last several decades, with populations reaching a peak all over the world, the answer has been: not very much.

        But that attitude will likely change over the coming several decades. South Korea’s total fertility rate is now 0.78. In Korea, there are now 3 times as many 50-year-olds as there are 5-year-olds. Japan’s population has already peaked and is heading down. Yi Fuxian at the University of Wisconsin-Madison predicts that China’s population will fall by more than half over the rest of this century. If Europe and the U.S. manage to avoid such drastic drop-offs in population, it will only be through immigration and not reproduction.

        My prediction is not so wild. Just as societies saw overpopulation as a problem and took steps to counter it, they will eventually see depopulation as a problem and will take steps to counter it. There is already anecdotal evidence that an abortion has become harder to obtain in China, where new births have hit a low not seen since the famine times of the Great Leap Forward.

    2. fjallstrom

      Population is still increasing, while birth rates are decreasing. To draw either of these trends in a straight line a couple of hundred years into the future is silly.

      There is tried and established methods for governments to get more kids, wether they want more soldiers, workers or consumers. They consist of transfering some of that future utility to the parents, in the form of money and free or heavily subsidised services. These kind of programs tend to give women higher status and power (through more money and more time), which in turn tends to lead to more rights for women over their bodies, including abortion rights.

      1. Dale

        No one is just drawing trends in a straight line. That is a strawman argument. But the mathematical models aren’t that complicated.

        A couple hundred years might seem like a long time, but that is only 8 or 10 human generations. Not so much time, in evolutionary terms, especially when the population is dropping by half with each passing generation.

        Population will peak relatively soon. Japan’s population has already peaked and is starting to decline. China’s has as well, or will soon. (The Chinese government is always dodgy about statistics.)

        Giving women higher status and power works a little bit, but not nearly enough. That is the approach Sweden has taken, for example. Sweden’s total fertility rate is 1.66, better than the 1.24 of Italy, where traditional gender role expectations are placed upon women to a much larger degree. But it doesn’t work nearly well enough. The *replacement* fertility rate is 2.2. A TFR of 1.66 merely delays the inevitable result.

  3. Hayek's Heelbiter

    To paraphrase JFK re the article and conservative war on Planned Parenthood et al., “Those who make contraception impossible will make abortion inevitable.”

  4. KD

    I also wonder why reproductive freedom advocates are not regularly reminding women…to use morning after pills

    . . . maybe because at the end of the day, they are pro-abortion advocates, because if women regularly used morning after pills OTC, the demand for abortion (lucrative for physicians) and the political case for its necessity would be greatly reduced. There are also the Peter Singer types, who want to rid the world of congenitally disabled children on utilitarian grounds, and want late-term abortion and genetic-screening in place to identify and then reduce the disabled population. This agenda cannot be satisfied by access to morning after pills.

    I remember asking the nurse why we would want amnio, and being pressured and going round and round, until we told them to stuff it.

    1. Stephanie

      I suspect this is due to easy availability in an urban area – lots of pharmacies on bus lines, lots of health services that focus on “youth wellness” – but since the morning-after pill became available otc, the younger women I’ve talked with about it seem to use it the way my cohort (Gen X) used condoms, as just another basic aspect of having sex. Most of the women I’ve discussed it with have used it at least a few times (or doubled up on their regular birth control pill, don’t know how effectively) and they all complained about side effects, but what else are you going to do?

      While I can sadly imagine all too well a U.S. healthcare system prioritizing the upsell, I am inclined to think that areas where the morning-after pill isn’t being used are probably pretty rural and accessing it requires more complicated logistics, which means more women who have to risk doing without.

      1. Joe Well

        If abortion is so lucrative, why are so few doctors or hospitals offering it?

        Seriously, try to find three abortion providers in your city or town. Now try to find three cosmetic surgeons. See the difference?

  5. Alan F

    could potentially be blocked down the road by an omnibus spending bill that includes a provision that allows the FDA to block “off label” uses of approved drugs.

    A provision inserted and pushed by so-called liberals and Democrats. Its major goals are to increase drug company profits, make us all greater slaves to the sickcare industry, and probably make the next pland, err, pandemic more deadly than the recently passed one.

    Would be so ironic if the goose-stepping left finds itself gored by their own evil creation here.

    All of the culture war fighting over abortion, and so little effort put into safe, reliable and affordable birth control, and adoption. The combination of which doesn’t neatly fit into either armed camp of the culture war.

    1. IM Doc

      The drugs in question are already approved by the FDA – so they are not being used “off-label”. The issue is whether the FDA did all the appropriate studies ahead of time to accurately gauge the risk/benefit ratio for patients. Unfortunately, because of the FDA’s behavior with regards to the COVID vaccines and the Alzheimer’s drug from a few years ago, and drugs like Paxlovid, it is clear that they have been playing a bit loosely with the rules. That being said, as a practicing physician, I am straining to remember a single instance where a patient had a single issue with the abortion pills. I just cannot remember a single time in my own practice. The same can not be said for either COVID vaccines or paxlovid.

      The language in the omnibus bill is for devices, at least at this point. There is some controversy whether that language can extend to drugs. There are many who believe this is a direct assault on doctors’ ability to prescribe things like ivermectin. The FDA by simple dictate, in a future crisis, would be able to say NOPE on anything they so desire for any reason they choose. That is very chilling. Look at medical history – for centuries – physicians find things that really work in crises by trial and error. This kind of fiat decision-making will not be good at all.

      We will rue the day that the FDA would be given this kind of power over off label drug usage. I could list off literally dozens of things that are used in this manner that are now considered standard of care. And this has so much potential to backfire. Once they are allowed to ban the use of ivermectin, I fully expect that next on the agenda will be all the drugs used to turn off puberty in the gender transition field. There is absolutely zero evidence of long term efficacy in the way these are being used. There is all kinds of evidence of great harm. The attorneys general in every red state and then some will see to banning these drugs too. These drugs, unlike ivermectin, are truly fraught with problems. Among them are drugs like Casodex which is an anti-testosterone agent. In my career, it is one of the top 5 drugs to be avoided – it causes massive problems in almost every patient. It is a drug approved ONLY for the treatment of prostate cancer. And yet, we are giving it off-label to throngs of younger than 18 boys. Mark my words, this will detonate and again the FDA and all the med-twitter docs pushing to ban ivermectin, etc are going to rue the day they started down this road….once the precedent is set – the gender transition drugs are going to be next and they are not going to like what happens.

      There are things that should just be left alone. Especially by those on a crusade.

  6. ambrit

    We Ultra Cynics have been warning about the truly extreme agendas of the religeously inspired anti-abortion groups for years now. The result has been “politics as usual.”
    Look for the return of an abortion rights “Underground Railroad.” This time, it will be bringing items into America.
    Also, look to the wily russkies to ‘weaponize’ this movement, literally, as they piggyback on the abortion medication smuggling groups to introduce real weapons into America to arm the “radical conservation groups.”
    “No more tree hugging! Today I announce the beginning of Alliance of Ecology Warriors targeted ‘composting’ program. CEOs, beware! The Friends of Mother Earth are coming for you!”
    Soon thereafter, expect a series of e-mail funds raising blasts.
    “Can you send just $5.00 to assist us in our sacred mission to purify the Earth? Help us improve the human gene pool by removing sociopaths, wherever they are found.”
    Brought to you by the Alliance of Ecology Warriors, a fully non-approved organization. Your donations are not tax exempt.

    1. Old Jake

      I found the position that plaintiffs lack standing as thought provoking.

      Yet apparently the author thinks that the case – due to the “eccentricities” of this particular judge and the judiciary environment at this time – will succeed.

      Indeed it is an interesting analysis.

  7. GiGi

    The affinity that some federal district judges have displayed for issuing nationwide injunctions is a debatable practice.

    In my opinion, the circumstances under which lower level courts should be allowed to arrogate this power unto themselves should be sharply curtailed. And the practice is equally suspect no matter where on the political spectrum a particular judicial action lies.

  8. GC54

    Perhaps the reason it isn’t used/advocated more is because it costs $50 a pill (Plan B) around here and, although OTC, is locked away at CVS (perhaps to avoid shoplifting).

  9. playon

    A provision that allowed the FDA to block “off label” uses of approved drugs would negatively affect pharma profits, so I’m pretty certain that would be in the na ga happen category…

  10. carolina concerned

    Read these posts. If you believe that this has anything to do with being anti-abortion, you are not reading these posts. This is about white nationalism, nothing else. The anti-abortion group are the most hypocritical group in the world, literally. The details about the abortion issue are not of any real consequence. This issue is about white nationalist power, not about abortion issues or the people that are going to suffer because of the white nationalists. The real issue here is the political parties and what must be done to regulate them.

  11. thoughtful person

    “Those who make contraception unavailable make abortion inevitable.” Yes, in biological reality, but this is about ideology. I’ve talked with anti choice protestors. They often oppose both abortion and contraception. The logic of this makes sense if you want a world where women no longer are doing anything other than childcare and unpaid household chores, like maybe in 1830? No education for women, no work opportunities etc.

  12. JR

    This is a civil procedure question, I guess, but how is it that a single federal district court in the northern district of Texas has the nationwide power to prevent the use of mifepristone for these purposes? I suspect it is b/c the federal district court has jurisdiction over the FDA and if it orders the FDA to rescind approval and the FDA does so, the FDA’s rescission has national effect b/c the FDA’s actions are national in scope. I wonder if one could block that effect by say, bringing an action in the San Francisco federal district court and, assuming the court approves, having the San Francisco district court enjoin the FDA from rescinding its approval of mifepristone. I suspect that the legal arms of NARAL, Planned Parenthood and others are either pondering that right now, or already know the answer to the question (as it may already be answered in the federal rules of civil procedure, or under the case law on the subject).

  13. Gusgus 2021

    They go on and on about human life
    But once they are born they don’t care look at the full blown crazy homeless everywhere.

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