The Kacsmaryk decision to apologise: “The Supreme Court won’t take up abortion again” — a critical reminder of the GOP’s struggle with women

US District Judge Matthew Kacsmaryk’s decision to suspend the Food and Drug Administration approval of the drug mifepristone, which has been used safely for more than 20 years, marked an extraordinary use of judicial power in the face of scientific data and is likely to force the Supreme Court to take up abortion again, a year after it overturned Roe v. Wade.

The intensity of the storm Kacsmaryk whipped up was evident in heated rhetoric between Republicans and Democrats on Sunday. Health and Human Services Secretary Xavier Becerra vowed that women would have safe and effective medication available after the administration launched a legal appeal to stop the suspension from going into force on Friday.

“The Court,” he wrote of his determination, “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.”

Such a move could severely impede a critical arm of the American health care system and deepen acrimony surrounding the regulatory approval process, which was attacked by conservatives amid skepticism of the Covid-19 vaccine.

The removal of a constitutional right to make decisions about one’s reproductive health and the fear that women would be unable to get contraceptives are just two of the concerns dismissed by Gonzales. His comment was exactly the kind of controversial statement that has contributed to Republicans’ struggles with female voters.

The decision by Kacsmaryk, a long-time opponent of abortion rights, is the latest occasion where a high-profile member of the conservative movement has launched a daring application of power in a way that Democrats argue trashes legal and democratic convention. Previous examples include the Republican majority’s expulsion of two Black state legislators from the Tennessee state House last week after they joined a gun control protest in the chamber; attempts by some conservative states to curtail voting access; and even Trump’s bid to overturn the 2020 election.

On Friday, a federal judge in Texas ruled that the Food and Drug Administration didn’t properly approve a drug which has been on the market for more than 20 years in the U.S. for medical abortions. The drug in question, mifepristone, is used along with one other drug in most medication abortions in the U.S.

It is reasonable to wonder if courts should have any role in reviewing the scientific decision-making of the F.D.A. In fact, judges do have an important job: protecting the ability of the agency to use science and expert judgment to support the health of the American people. The Texas decision undermines the role of the F.D.A. and is a threat to the safety of millions of Americans.

There’s a name for the day of the week when the F.D.A. finds itself in court: Monday. Also, Tuesday, Wednesday, Thursday and Friday. It can happen on the weekends too. The agency’s large stable of dedicated attorneys defends its actions on a multitude of issues. These include routine administrative matters such as whether the agency moved too fast or too slow on a generic drug approval or whether the agency has missed regulatory deadlines.

Medication Abortion versus Pregnancies in California: The Case of Kacsmaryk, Newsom, James, and the FDA

But some of those states have disputed the idea that Kacsmaryk’s ruling outlaws medication abortion — a procedure that’s widely considered safe and accounts for more than half of US abortions. “Abortion is still legal and accessible here in California and we won’t stand by as fundamental freedoms are stripped away,” said the office of California Governor Gavin Newsom following the ruling. Likewise, New York Attorney General Letitia James issued a statement that “abortion continues to be legal in New York and New York will remain a safe haven for anyone seeking abortion care.”

F.D.A. will allow mail-in chemical abortion in 2021, meaning that many women and girls will consume it without doctor supervision. Women who use maternity-care deserts may not have ready access to emergency care. There are fewer rules for women and girls today than in the past. The plaintiffs have reason to believe their injuries will continue, perhaps with a greater frequency than in the past.

The new abortion medication dispute now moving up through appellate courts, however, centers on important but dry issues of legal standing, the deadline for filing a lawsuit against the FDA and whether, if the merits of the case are reached, the agency’s actions were arbitrary and capricious.

This uncertainty doesn’t mean you cannot get a medication abortion in the US. Mifepristone is prescribed in a two-drug combination to assist in the birth of a child. The second half of the combination, misoprostol, is also an effective abortifacient in its own right — in addition to being used for other conditions like ulcers. Plan C has a detailed guide for access to the medication, but anyone ordering it in states where abortion is not allowed could face legal risks.

With the two-drug regimen, patients first take mifepristone – which blocks the hormone progesterone – to end the pregnancy. Patients then take misoprostol 24-48 hours later, which causes the uterus to expel the pregnancy tissue. After taking Misoprostol, patients will experience bleeding and cramping, which can last for up to 3-6 hours.

There’s lots of research that shows the misoprostol-only protocol is as safe as the two-medication protocol – but it does tend to cause more side effects.

A Democratic Congressional stance against the Supreme Court ruling overturned “Roe v. Wade” for misoprostol

If patients experience heavy or prolonged bleeding – spotting that persists for over 2 weeks, for example, or bleeding so heavy they soak through more than two pads an hour for over two hours – they might need a procedure to complete the abortion.

It’s a good idea to seek medical care for a long high temperature of 100.4 degrees Fahrenheit. While low-grade fevers and chills are an expected side effect of misoprostol and aren’t life threatening, if a fever persists for more than 24 hours after taking misoprostol, it could be a sign of infection.

The FDA approved the two-drug regimen to end pregnancies after 10 weeks of age, but the World Health Organization recommends it be used up to 12 weeks. They’re less likely to be effective after that.

In states where abortion is legal in the first trimester, a patient can speak to a health care provider and get a prescription for abortion via e-mail or telephone, as long as the abortion is not done in person.

A Republican congresswoman who represents a swing district in South Carolina urged the Food and Drug Administration on Monday to ignore a recent ruling by a federal judge suspending the approval of a medication drug used for abortion.

This is approved by the FDA. I support the usage of FDA-approved drugs, even if we might disagree,” Rep. Nancy Mace told CNN’s Kaitlan Collins on “This Morning.” It is up to the court to decide whether or not this is the right drug to use.

Mace considers herself “pro-life,” as does virtually every Republican office-holder on the national level. But in the wake of last year’s Supreme Court ruling overturning Roe v. Wade, the party has had to navigate a political landscape in which harsh restrictions on the procedure have proven politically unpopular.

Democratic Sen. Tina Smith of Minnesota told “CNN This Morning” on Monday that ignoring the ban “just throws us into another level of chaos that I don’t want to know where that ends up.”

The US Department of Justice, on behalf of the FDA, forcefully rejected Kacsmaryk’s stance in a filing Monday as it seeks to postpone the effect of his ruling beyond this Friday as appeals are underway. If the ruling took effect, the drug could be unavailable nationwide by the end of the week.

Acting last Friday soon after Kacsmaryk in the Texas-based FDA challenge, US District Judge Thomas Rice issued an order that would prevent the FDA from changing rules that would affect the availability of mifepristone in the 18 jurisdictions that were part of the litigation.

The order will not be in effect for the next seven days to give the DOJ time to appeal. If the Justice Department doesn’t win a stay from the 5th Circuit, it is expected to appeal to the Supreme Court.

There was a judge in that case who was appointed by the Obama administration. But he did rule Friday that the agency cannot alter access to the drug while the lawsuit proceeds. That decision could offer relief if the Texas injunction goes into effect — though it would be limited to those 17 states and the District of Columbia.

Newsom, Healy, and Pro-Life America: State and Local Control of Mifepristone and Other Misoprostol

Gov. Gavin Newsom’s office says it’s made plans to secure an emergency stockpile of up to 2 million pills of misoprostol, a drug used in combination with another pill that is now the subject of legal battles in federal courts. The state currently has about 255,000 pills, which were purchased for about $100,000.

Meanwhile, Massachusetts Gov. Maura Healy said Monday afternoon that her state has stockpiled some 15,000 mifepristone pills or more than a year’s worth of doses. Washington has enough of the drug for three years, according to the governor last week.

Newsom’s office says the pills were secured through the state’s CalRx prescription drug program, and California is providing information about its purchase agreement to other states that may be interested in taking similar action.

Pharmacies facing shortages will be directed to a state website where they can find information about how to request pills from the misoprostol supply.

Mifepristone has been approved by the US Food and Drug Administration for 23 years, and it has been used by over 5 million women in the United States. There are a small percentage of women who take it who have significant adverse events. An analysis of FDA data by CNN shows that mifepristone is less risky than some other commonly used drugs.

The Biden administration was appealing the Texas decision and the court is expected to make a decision this week. It may be up to the Supreme Court to resolve the conflicts.

The director of state policy at Susan B. Anthony Pro-Life America said that everyone’s eyes are now towards D.C. “We anticipate that eventually, whether it is the merits of this case or these injunctions — now dueling injunctions — that the Supreme Court will have to weigh in in some way.”

The Texas lawsuit, filed by a coalition of abortion rights opponents, raised questions about the process by which the FDA originally approved the drug in 2000.

Meanwhile, there’s a competing ruling out of Washington state, where the attorneys general of 17 states and the District of Columbia had sought to force the FDA to expand access to the drug.

Some states are Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont and Washington.

The Supreme Court’s Indirect Decision to rescind Roe v. Wade and its Consequence for Women’s Privacy Rights and Abtressibility

The drug is available for now. The government was given a week to appeal, which is one of the legal measures that have been put in place to prevent the ruling from taking effect. In a case brought by 17 states and the District of Columbia, the US District Judge Thomas Owen Rice ordered the FDA to keep the drug available.

“For example, if medication is already in pharmacy and has already been prescribed, can those prescriptions be filled?” said David Donatti, an attorney at the ACLU of Texas. The lowest court order doesn’t answer these questions.

“We absolutely hope the Supreme Court resolves this issue once and for all. Youman is an attorney with Human Coalition which filed an “admisstory brief” in the Texas case.

The Supreme Court’s reversal of Roe v. Wade last June was decades in the making, culminating in a dramatic evisceration of women’s constitutional privacy rights and ability to obtain an abortion.

“It’s going to be working closely with legal advisers in a really rapidly changing environment. That’s what I foresee in the next seven days, and likely beyond that,” said Melissa Grant, the chief operating officer at Carafem, an abortion provider that provides mifepristone at its three physical clinics and via telehealth.

Patients who planned to get medication abortions next week are being told to change their plans by staffers at Northeast Ohio Women’s Center.

The drug helps soften and open the cervix, the neck of the uterus, and doctors depend on it to help when women are having a miscarriage and when a pregnancy needs to be terminated quickly if the life of the mother is at stake.

Dobbs, Kavanaugh and Carafem: Medical groups do not advocate that abortion is necessary in cases of rape

Time is important when a pregnant woman becomes too risky, says the director of complex family planning at Oregon Health and Sciences University.

“The more expediently that we can have somebody not be pregnant, the better, and mifepristone helps us speed that process up and make it safer for patients,” she said.

Doctors say they can still treat those problems, but they won’t be able to give individual patients a useful tool.

If it isn’t available, then we use the next best regimen and have the gold standard of what we provide. And that’s what we would be left with,” Edelman said.

Carafem, which provides telehealth abortion care, has been using a misoprostol-only regimen since the Covid-19 pandemic began, Chief Operating Officer Melissa Grant says.

“The clinicians would have to use these other options instead of choosing based on their own expertise, knowledge and judgment when rendering such care,” Dr. Iffath Hoskins, president of the American Congress of Obstetricians and Gynecologists, said Monday. “Frankly, as a clinician, I do not want to be in that position.”

Equally important in the continuing battle over abortion rights, if the decision stands, it would diminish access to abortion even in states that currently allow it. When the Supreme Court ruled in the case of Dobbs v. Jackson Women’s Health Organization last summer, the narrow majority emphasized that they were removing judges from the business of abortion regulation and returning the issue to the individual states.

Justice Brett Kavanaugh, the apparent key fifth vote in favor of that decision, wrote a separate statement, declaring that judges would no longer decide “difficult moral and policy questions” related to abortion.

He pointed out in his footnotes that the word “fetus” is used in opinions, but that he favors “unborn human or child”.

The position taken by the American College of Obstetricians and Gynecologists that abortion in cases of rape was not considered to be “abortions” was contrary to testimony given by abortion opponents. (By taking this position, abortion opponents can still defend bans with no or few exceptions by claiming that abortion is never necessary.)

DOJ lawyers have argued that the medical groups challenging the FDA lack standing to sue because they have no actual injury and offer baseless speculation regarding harms to women and the medical profession from mifepristone.

CNN analyzed data and it shows that the drug can be even safer than prescription drugs, such as penicillin and Viagra. The risk of death by penicillin, for example, is four times greater than it is for mifepristone, according to a study on life-threatening allergic reactions.

Kacsmaryk contended, however, the FDA had failed to consider “the intense psychological trauma and post-traumatic stress women often experience from chemical abortion.” He said that use of the drug had led to more deaths and adverse reactions than the FDA has acknowledged.

The DOJ lawyers said Kacsmaryk cherry-picked dubious materials to support his position, and some doctors were quick to try to refute the judge’s medical conclusions.

The Politics of Abortion and the Courts: The Case of Kacsmaryk, Gonzales, Carhart, Mifepristone

In the last six years, voters have sided with abortion rights in six out of six ballot initiatives, which boosted Democratic candidates, and transformed the Wisconsin Supreme Court. A recent poll shows that nearly two-thirds of Americans don’t want medication abortion to be legal.

This strategy changes the regulations of abortion providers and the laws that make it compulsory for women to receive vaginal and medically unnecessary tests. State legislatures enacted burdensome laws requiring waiting periods before a woman can legally terminate a pregnancy. A woman is more likely to die if she carries a pregnancy to term than if she has an abortion.

When the Supreme Court upheld the federal Partial-Birth Abortion Ban Act in 2007, dubious scientific arguments became even more central to antiabortion advocacy. In Gonzales v. Carhart, the court held that in circumstances of scientific uncertainty, legislators would have more latitude to regulate abortion. The antiabortion groups were incentivized to create uncertainty by using their own data and witnesses.

Implausible scientific claims are now visible on social media, in lawsuits and in congressional hearings. Students for Life of America is trying to get the FDA to consider the effects of abortion on wastewater when granting approval for the drug Mifepristone.

That Kacsmaryk embraced snake-oil science underscores concerns that broader dangers loom. This case shows the point that challengers do not need science or even standing to file a lawsuit. All that matters is control of the courts.

The case of F.D.A. vs. FDA: is it worth asking the court to reconsider its approval of an abortion drug?

During early pregnancies, usually at 12 weeks, abortion with medication can cause blood clot in the uterus, and this can be prevented through regular checking of the patient. Patients cite varying reasons for having abortions, but several studies and surveys have suggested that patients often feel relief and experience fewer mental health symptoms like depression, anxiety and suicidal thoughts after terminating pregnancies they felt unprepared or unable to handle.

The theories of standing are dependent upon layer after layer of speculation according to defendants. According to those who sued F.D.A., its abortion regimen caused a lot of side effects and put patients at risk.

F.D.A.’s 2016 and 2021 changes thus significantly departed from the agency’s original approval of the abortion regimen. F.D.A. repeatedly altered its original decision by removing safeguards and changing the regulatory scheme for chemical abortion drugs.

Another point of contention in Judge Kacsmaryk’s order centers on the statute of limitations to file a lawsuit challenging the F.D.A.’s approval of a drug, which is six years. In 2016 the F.D.A. made it possible for people to take the pill in person, and then the requirement was lifted in 2021. The Justice Department said that it was too late to challenge the 2016 and 2000 decisions and only the most recent measure fell within the six-year limit. Judge Kacsmaryk interpreted each change as restarting the clock to challenge approval for the drug.

At this point in time, it is not a good idea to make predictions about what will happen. “This is pretty unprecedented, and could have pretty broad impacts for the entire pharmaceutical industry. So we’ll have to wait and see how it plays out in the appeals courts,” says Donley.

“While PhRMA and our members are not a party to this litigation, our focus is on ensuring a policy environment that supports the agency’s ability to regulate and provides access to FDA-approved medicines,” said the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the largest biopharmaceutical research companies in the United States, in a statement sent to journalists on request.

During a media briefing on 10 April, Jessica Ellsworth, the lead counsel for Danco in this case, said she’s hopeful that either the appeals court or the Supreme Court will suspend the decision before 14 April.