The Justice Department wants a court to freeze the judge’s order that may affect abortions on Friday
The Analog of Kacsmaryk vs. Ocasio-Cortez: On the Importance of the Court Decision on Fertilizing Abortion
Access to a common abortion medication currently hangs in the balance in a pair of contradictory decisions by federal judges, setting the stage for the most significant legal action on abortion since the overturning of Roe v. Wade last year.
The intensity of the storm Kacsmaryk whipped up was evident in heated rhetoric between Republicans and Democrats on Sunday. The suspension from going into effect on Friday was stopped by a court injunction and the secretary promised that women would have safe and effective medication.
There will be virtually no prescription if the ruling is upheld, said the US President in a statement.
The regulatory approval process for the Covid-20 vaccine was attacked by conservatives because of their skepticism of the vaccine.
Mace’s comments on Monday align her with a position expressed by progressive Democratic Rep. Alexandria Ocasio-Cortez, who on Friday called for the ruling to be ignored, saying that if it was ultimately upheld by the Supreme Court, “it would essentially institute a national abortion ban.” But several Republicans, including Rep. Tony Gonzalez on CNN, have fiercely pushed back on the suggestion to ignore the ruling.
Kacsmaryk’s ruling is part of a strategy to take the question away from voters and to reframe abortion as something that ordinary Americans neither understand nor get a say about. Such an approach isn’t new, and it’s not going anywhere anytime soon; if the antiabortion movement can’t win in a fair democratic fight, its members will seek out ways to change the rules.
The Alliance for Hippocratic Medicine used dubious arguments to challenge the approval of the medication, which had been approved by the Food and Drug Administration in 2000.
The decision is so stunning that it is reasonable to ask whether courts should have any role in reviewing the F.D.A.’s scientific decision-making at all. Judges do have a job of protecting the ability of an agency to use science and assess judgement to support the health of the American people. The Texas decision is a perversion of this role and, by undermining the F.D.A., represents 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. Sometimes on the weekends too. The agency’s large stable of dedicated attorneys defends its actions on a multitude of issues. There are some administrative matters such as whether the agency moved too fast or slow, or missed regulatory deadlines.
Is abortion safe? The case of the Comstock Act, the Fifth Circuit, and the Food and Drug Enforcement Commission (FIRST COURT OF Appeals)
Judge Kacsmaryk’s opinion cites a handful of studies, several conducted by anti-abortion organizations, that the plaintiffs in the case submitted as evidence. The judge devotes little attention to the scores of studies that have shown medication abortion is very safe and that complications are rare, with patients needing hospitalization in less than 1 percent of cases.
The Comstock Act declares “nonmailable” every “article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use it or apply it for producing abortion.” 1465 (words added), according to the 18 USC. It is indisputable that chemical abortion drugs are both “drug[s]” and are “for producing abortion.” Therefore, federal criminal law declares they are “nonmailable.”
The stay could be reversed by the Fifth Circuit Court of Appeals, which could have muddy effects in the short term. (The Fifth Circuit is notably the one that allowed a ban on internet moderation to stand in 2022.) The FDA had power to limit the ruling if it was allowed to stand, according to members of the Women’s Law Project. The response may have an impact on whether manufacturers and sellers of the drug keep patients with the pill.
How Many Patients Can Get Misoprostol Without a Doctor? An Insight from the South Carolina Senator Nancy Mace on a Case Study of Telehealth Abortion
Most medication abortions in the U.S. currently use both mifepristone and misoprostol because patients experience fewer side effects when the medications are combined. A regimen involving both medications is also used for miscarriages.
It’s less clear for abortion with misoprostol. There’s some data showing that the regimen can be effective in ending pregnancies up to 22 weeks. The study looked at patients having abortions without the help of a doctor, in countries with restrictive abortion laws.
“We now feel confident that, even though we would much prefer to use both, that we can use misoprostol alone effectively and are ready to switch gears to have a higher percentage of our clients or even 100% of our colleagues use that option if necessary,” Grant said.
Patients who have been bleeding for more than a week or who have been bleeding for more than two hours can have a procedure done to complete the abortion.
A high temperature of 100.4 degrees will make you want to seek medical care. 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 World Health Organization believes that the two-drug regimen to end pregnancies can be used up to 12 weeks. It’s more likely that they’re less effective after that.
For instance, Mayday. Health offers step-by-step instructions for setting up a mail-forwarding address, so patients can list an address in a permissive state on their intake forms for a telehealth abortion, then get the pills sent along to an additional address somewhere else. Plan C is a website that provides up-to-date information about how to get abortion pills at home.
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 an FDA-approved drug. 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 isn’t up to us as legislators or even as the court system 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 request, filed on Monday before the US 5th Circuit Court of Appeals, is seeking a short-term administrative stay as well as a long-term stay pending appeal on a lower court ruling from US District Judge Matthew Kacsmaryk, who ordered the Food and Drug Administration’s approval of the drug to be suspended.
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 decision of the appeals court is likely to come by Friday, April 14. The decision will be appealed to the Supreme Court if it is decided differently than before.
The judge in the case was appointed by the president. The agency can’t alter access to the drug while the lawsuit proceeds. If the injunction in Texas goes into effect, that decision could offer some relief for those 17 states and the District of Columbia.
Newsom’s Order and the Inslee’s Supremum: A Search for an Emergency Misoprostol Supply
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 more than 100,000 pills, which was purchased for $100,000.
Massachusetts has over a year’s worth of prescriptions for more than 15,000 pills, the governor said on Monday. Last week, Washington Gov. Jay Inslee announced his state had prepared a stockpile of about three years’ worth of mifepristone.
California’s purchase agreement for the pills is information that other states may be interested in getting, as well as the fact that they have secured them through the state’s CalRx prescription drug program.
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. FDA data shows that less than 1% of women who take it have significant adverse events. A CNN analysis of FDA data found that the risk of having a heart attack with Viagra and penicillin was less than with the drug mifepristone.
The Biden administration is appealing the Texas decision and the federal appeals court is expected to make a decision this week. The Supreme Court may be able to resolve the conflicts.
“Everyone’s eyes are looking back towards D.C.,” stated the state policy director at Susan B. Anthony Pro-Life America. “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.”
A Texas lawsuit by abortion rights opponents raises questions about the process by which the FDA approved the drug in 2000.
There is a ruling out of Washington state where the attorneys general from 17 states and the District of Columbia tried to force the FDA to expand access to the drug.
(Those states are Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont and Washington.)
Do doctors know a drug is available? The first seven days of the Supreme Court ruling against Kacsmaryk’s ruling overturned the abortion law
For now, the drug remains available. The government was given a week by Kacsmaryk to appeal the ruling, one of a number of legal measures underway to keep the ruling from happening. In a case brought by 17 states, the U.S. District Judge ordered the FDA to keep the drug for those states.
David Donatti, an attorney at the American Civil Liberties Union of Texas, asked if the prescriptions can be filled if the medication is already in pharmacy. “These are questions that the lowest court order just does not answer.”
We hope the Supreme Court resolves this issue once and for all. “It’s been decades in the making,” said an attorney from the Human Coalition about their role in the Texas case.
Since the Supreme Court swung conservative and overturned Wade, abortion providers have been working with lawyers to plan for different scenarios.
“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 were supposed to get medication abortions next week have been told to change their plans.
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.
Is the Supreme Court Right to Make the Right Decisions about Abortion? Dr. Alison Edelman, a Family Planning Psychiatric Specialist, explains the case of Dobbs
In certain situations, when a pregnancy has become too risky, time is of the essence, says Dr. Alison Edelman, who directs the division of Complex Family Planning at Oregon Health and Sciences University.
The drug can carry a low risk of major outcomes according to the pharma executives letter. A review was done in the journal Contraception and it showed that only a small number of people were hospitalized when they took both mifepristone and misoprostol.
Doctors say they still have other ways to treat those problems, but when considering the needs of individual patients, they will be missing a valuable tool.
“We have our gold standard of what we provide – the safest, most effective regimen – and then if it’s not available, we use the next best one. And that’s what we would be left with,” Edelman said.
Carafem has been using a regimen that only involves the use of the drug misoprostol since the start of the PAIN crisis, according to the Chief Operating Officer.
“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.
The Justice wrote that judges no longer will decide difficult moral and policy questions related to abortion.
He observed in a footnote that jurists often use the word “fetus” in opinions – as in fact the Supreme Court did in its Dobbs decision – but that he was favoring “unborn human” or “unborn child.”
Many antiabortion groups have long tried to undermine abortion by claiming that it harms girls and women — and that abortion opponents were seeking to protect pregnant people from the “abortion industry.”
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.
Data analyzed by CNN shows mifepristone is even safer than some common, low-risk prescription drugs, including 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.
The FDA did not consider psychological trauma and post-traumatic stress when making their ruling on chemical abortion, argued Kacsmaryk. He maintained that use of the drug had caused many more deaths and severe adverse reactions than the FDA had 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.
What does science tell us about abortion laws: The case of Senator Kacsmaryk and the Wisconsin Supreme Court in response to the Wisconsin abortion debate”
Since 2022, voters have sent a clear message when the question is what abortion law ought to look like: They have sided with supporters of abortion rights in six out of six ballot initiatives, boosted Democratic candidates and, just last week, transformed the Wisconsin Supreme Court. A recent Ipsos poll found that nearly two-thirds of Americans want medication abortion to be kept legal.
This strategy underwrote the regulations of abortion providers, clinics and statutes that force women to receive vaginal and medically unnecessary tests. State legislatures enacted laws that made it difficult for a woman to legally end a pregnancies. This is all despite the fact that a woman is more likely to die if she carries a conception to term than if she chooses to 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. The court held that abortion can be regulated if there is scientific uncertainty. That incentivized antiabortion groups to identify or manufacture uncertainty by creating their own data and fielding their own witnesses.
Implausible scientific claims are now visible on social media, in lawsuits and in congressional hearings. In a separate fight, for example, the antiabortion group Students for Life of America has asked the FDA to reconsider its mifepristone approval by making claims about the ill effects of abortion on wastewater.
That Kacsmaryk embraced snake-oil science underscores concerns that broader dangers loom. If his ruling stands, this case sends a message that challengers don’t need to have science on their side, or even the standing, to sue. Control of the courts is all that matters.
The New F.D.A. Review of the Case for Chemical Abortion in the United States and Comment on the Motion by the Pharmaceutical Research and Manufacturers of America
Women who have aborted a child — especially through chemical abortion drugs that necessitate the woman seeing her aborted child once it passes — often experience shame, regret, anxiety, depression, drug abuse and suicidal thoughts because of the abortion.
Defendants contend that plaintiffs’ theories of standing “depend upon layer after layer of speculation.” The lawsuit claims that F.D.A.’s regimen of chemical abortion made their patients suffer significant side effects and required them to be looked after.
The changes that the F.D.A. has made over the course of a decade significantly departed from the original approval of the abortion regimen. F.D.A. changed its initial decision many times, changing the regulatory scheme for chemicals used in abortion drugs.
The judge disagreed over the six year time limit to file a lawsuit over the F.D.A. approval of a drug. The in-person requirement for the pill will be lifted in 2021, just after the F.D.A. approval of the drug in 2000. The Justice Department argued that it’s too late to bring a lawsuit against the 2000 and 2016 decisions because the most recent one falls within the six-year limit. Judge Kacsmaryk interpreted each change as restarting the clock to challenge approval for the drug.
Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines could endanger the innovation that characterizes our industry and reduce incentives for investment. Among them are executives of prominent drug companies including Pfizer, AbbVie and Bristol Myers Squibb.
“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.
