The court ruling on abortion drug had clinics bracing for more restrictions
The Kacsmaryk Argument: Why Science Matters to Women and Why Do We Need It? Why Does Science Matter? What Happens When Medicine is Available in the United States?
His ruling on Friday, which he paused for a week to allow appeals, also represented a judicial intervention into the health care decisions of millions of American women and could effectively make abortion unavailable in many states if it goes into force. The Biden administration is already mobilizing to thwart the judge’s audacious move after lodging an appeal.
The intensity of the storm Kacsmaryk whipped up was evident in heated rhetoric between Republicans and Democrats on Sunday. The secretary of health and Human Services vowed that women would have access to safe and effective medication after the administration launched a legal appeal to stop the suspension from going into force.
The FDA was told to keep abortion pills on the shelves in 17 states, and the District of Columbia which sued to make it harder to get them. A US judge ruled that the FDA could not take any actions that would decrease the availability of the drug.
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.
“It’s important that we have real discussions on women’s health care and … get off the abortion conversation,” Gonzales told Bash. Women have more issues than just abortion. Let’s talk about what’s happening in this world, and have those real conversations.
The new controversy over medication abortion, which has burst relatively suddenly on the legal scene, has the potential for another seismic ruling at the Supreme Court.
In his 67-page decision Friday, Kacsmaryk demonstrated frustration, bordering on contempt, for the FDA process. He admitted that he did not like abortion. In his research, he said that the drug Mifepristone starves the unborn person until death.
It is reasonable to ask whether courts should review the scientific decisions of the F.D.A. Judges have an important job, and it is protecting the ability of the agency to use science 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.
Monday is the day when the F.D.A. finds itself in court. Also, Tuesday, Wednesday, Thursday and Friday. Sometimes on the weekends as well. The attorneys who work for the agency defend its actions on a lot of issues. Whether the agency moved too fast or slowed on a generic drug approval or missed regulatory deadlines are routine administrative matters.
On the resurgence of obscenity laws: The state of the law outlaws medication abortion and its impact on the Fifth Circuit
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.”
The case is notable because it uses an obscenity law thatbans the shipping of materials related to abortion. The opinion interpreting the ban on advertising or describing articles, instruments, substances, drug, medicine and other things in a way that leads someone to use it or apply it for producing abortions is similar to the ban on mailing abortion-inducing drugs. “The statute plainly does not require intent on the part of the seller that the drugs be used ‘unlawfully,’” Kacsmaryk writes. It’s the latest sign that long-dormant obscenity rules are being resurrected following an unsuccessful attempt to ban books in Virginia using a mostly forgotten state statute.
The ruling’s impact on the future is dependent upon the Fifth Circuit Court of Appeals reversing the stay. The internet ban was allowed to stand by the Fifth Circuit. In February, members of the nonprofit Women’s Law Project argued that the FDA had substantial power to limit the ruling’s effects even if it were allowed to stand. Its response may determine whether manufacturers and sellers of the drug maintain patients’ access to the pill in the face of legal uncertainty.
Medication abortions have become an increasingly important option for women in states that restricted abortion access after the Supreme Court’s ruling last year that ended legal protections for abortions in every state. They are also sometimes the only kind of abortion many women can get in rural areas that have lost abortion providers.
The FDA was urged by a South Carolina congresswoman to ignore a judge’s ruling suspending the approval of a drug used in abortion.
“This is an FDA-approved drug. Nancy Mace told CNN that she supports the usage of FDA-approved drugs even if we disagree. “It’s not up to us to decide as legislators or even, you know, as the court system that whether or not this is the right drug to use or not.”
“This is an issue that Republicans have been largely on the wrong side of,” Mace continued. We do not show compassion towards women over the last nine months, and this is an issue that I have tried to highlight as someone who is pro-life and just have some common sense.
Tina Smith of Minnesota told CNN that she did not want to know what the consequences of the ban would be.
The Justice Department is preparing to make misoprostol unavailable while the case against Danco is pending appeals to the Texas Injunction
The Justice Department asked a federal appeals court on Monday to put on hold a judge’s ruling that could make a medication abortion drug unavailable nationwide starting Friday at midnight.
An administrative stay would give the appellate court more breathing room to consider whether Kacsmaryk’s ruling should be frozen while the litigation plays out. The Justice Department and Danco, a manufacturer of the drug mifepristone that intervened in the case to defend the FDA’s approval in 2000, had both already filed notices of appeal.
The decision from the appeals court will likely come before Friday, April 14. If the decision is appealed, it will almost certainly be done in a way that goes to the Supreme Court.
The judge in the case is an Obama crony, Thomas Rice. 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.
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 has more than 200,000 pills on hand and was purchased for $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. Last week, Washington governor Jay Inslee announced that his state had prepared a three years worth of mifepristone.
The FDA has approved mifepristone, but has not yet been approved by the State of California. Insights from California, Newsom’s office, and an appeals court ruling out Washington state
The only regimen that uses misoprostol is less effective than one that uses both drugs, so it can cause more problems.
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.
There is information about how to request pills from the supply on the state website.
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 mifepristone was even less risky than some other common medications, including Viagra and penicillin.
The Biden administration has appealed the Texas decision, and a federal appeals court is likely to weigh in this week. It’s up to the Supreme Court to resolve the conflicts.
“Everyone’s eyes are now pointed back towards D.C.,” said Katie Glenn Daniel, 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.”
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.
Among those states are Arizona, Connecticut, Delaware, Hawaii, Illinois, Maine, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont and Washington.
For residents of those states, Rice’s decision “preserves the status quo on ensuring that access to mifepristone remains available,” said Washington Attorney General Bob Ferguson to NPR on Friday.
David Donatti, an attorney with the American Civil Liberties Union of Texas, asked if prescriptions that have already been written can be filled. “These are questions that the lowest court order just does not answer.”
The Supreme Court should resolve this issue in one fell swoop. An attorney with Human Coalition, an anti-Abortion-rights group, said it’s been decades in the making.
In the past few years after the Supreme Court moved to the right and the Wade decision was overturned, abortion providers consulted with lawyers and prepared for many scenarios.
It’s going to work closely with legal advisers in a very fast changing environment. “That is what I think will happen in the next seven days, and likely beyond that,” saidMelissa Grant, the chief operating officer at Carafem.
At Northeast Ohio Women’s Center, staffers are calling patients who expected to get medication abortions next week, telling them to change their plans.
Probing abortion in the U.S.: Inadequacy of the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization
It can be used to prevent bleeding between periods and to control hyperstimulation of the ovaries during in-vitro fertilization, the society said in a statement.
If apregnancy has become too risky, time is of the essence, according to Alison Edelman, who directs the division of Complex Family Planning.
She said the more expedient it is that we can have somebody not be pregnant, the better.
Doctors have other ways to treat those problems, but will be missing a tool if they don’t consider the needs of individual patients.
“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. That would be the only things we would be left with.
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.
According to the American Congress of Obstetricians and Gynecologists, clinicians would have to use these other options instead of using their own expertise when rendering such care. “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.
In the case of that vote, Justice Kavanaugh wrote a statement that claimed judges wouldn’t decide 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.”
Any abortion-rights dilemma is bound to incite religious and cultural passions, along with profound questions about a woman’s right to make the deeply personal decisions related to a pregnancy.
The FDA should not have given a real injury or allegation of harm to women and the medical profession from mifepristone
The medical groups challenged the FDA do not have a right to challenge it because they do not have a real injury or an allegation of harm to women and the medical profession from the drug.
The data analyzed by CNN shows that mifepristone isn’t any more risky than other prescription drugs. 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 maintained that use of the drug had caused a lot of deaths and severe reactions that the FDA had not acknowledged.
Some doctors were quick to try and argue against the judge’s conclusions, since DOJ lawyers said Kacsmaryk cherry picked dubious materials to support his position.
