Kacsmaryk’s decision to take down the new abortion medication dispute is a battlefield against abortion advocates and medical groups: a ruling on mifepristone

The challenge by anti-abortion physicians and medical groups tests the US Food and Drug Administration’s authority to review and approve drugs for use. It brings a host of questions about agency protocols and judicial deference to federal courts.

The new abortion medication dispute is moving up through the appellate courts and focuses on dry issues like legal standing, the deadline for filing a lawsuit and whether the FDA actions were arbitrary and capricious.

US District Judge Matthew Kacsmaryk in his Friday ruling put himself in the shoes of agency experts, declaring that they had failed to evaluate sufficiently the harms of the drug mifepristone, the first of a two-drug abortion regimen that has become the most common among women trying to end a pregnancy.

If this ruling is to stand then there will be virtually no FDA approved drug, that would be safe from these kinds of attacks, said US President Joe Biden in a statement.

In addition, the leaders of pharmaceutical and biotech companies condemned Kacsmaryks opinion in a sign that they are worried it will affect other drugs and undermine the regulatory landscape. Those arguments won’t be lost on the justices.

Danco said in Monday’s filing that Kacsmaryk’s narrative never mentions millions of women who have benefitted from the availability of medication abortion or the harms an injunction would wreak on Dan.

The case is being seen by abortion opponents as a prime battlefield for further decreasing women’s opportunities to end pregnancies. The challengers, a group of anti-abortion physicians and medical groups, had specifically sought out Kacsmaryk’s court for their lawsuit. The judge has worked at a conservative Christian legal advocacy group before being appointed by former President Donald Trump.

This strategy would be most suited in this situation, since the court decision on 7 April directly undermines Kacsmaryk’s orders. In a separate case, a group of 17 states and Washington DC sued the FDA to ease certain restrictions on mifepristone access. In the Eastern District of Washington, Judge Rice blocked the FDA from changing their policies to reduce the availability of the drug in certain states. Donley says that the only way the FDA could comply with both conflicting orders would be by exercising its enforcement discretion.

The decision from Kacsmaryk’s Amarillo courtroom was much more urgent and drew the attention of Biden administration lawyers.

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.”

Do Judicial Circuit Courts Describe the FDA Approval of Mifepristone and Other Pseudoscalar Drugs

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.

There are no grounds for challenging the approval of Mifepristone, even after 23 years after it was approved. The drug received extensive review — more than four years — before FDA approval. There are no concerns about the health of those who take it. Viagra and penicillin have a worse safety record than the drug. It was available and used in Europe for many years.

The DOJ lawyers said that Kacsmaryk cherry-picked questionable materials to support his position and some doctors tried to downplay the judge’s conclusion.

Why should abortion providers and clinics be allowed? Scientific arguments against the abortion ban act when the U.S. Supreme Court ruled against abortion

Reproductive health providers and experts say that medication abortion, which is typically used in the first 12 weeks of pregnancy, would still be available in some form. The F.D.A. can decide not to take action against providers if it’s sent from overseas. And some providers would switch to prescribing only the second abortion medication, misoprostol. More patients would likely need to seek surgical abortions if the ruling was to be followed, it would create uncertainty and likely chaos.

The Justice Department said that it would upend the status quo and seriously harm women, healthcare systems and the public if Danco Laboratories and GenbioPro were required to stop distribution after more than two decades.

When voters are asked if abortion law should look like, they have sided with the pro-choice side in six out of six ballot initiatives. Nearly two-thirds of Americans want medication abortions to be legal according to a recent poll.

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.”

The strategy under wrote targeted regulations of abortion providers, clinic regulations and statutes which forced women to receive medically unnecessary and insufficiencies vaginal probes. State legislatures enacted burdensome laws requiring waiting periods before a woman can legally terminate a pregnancy. This all despite the fact that a woman is about 14 times more likely to die by carrying a pregnancy to term than having 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. The court held that the legislature had the ability to regulate abortion if there was scientific uncertainty. Antiabortion groups were given incentives to make uncertainty by creating and fielding their own witnesses.

Scientific claims are visible in congressional hearings and on social media. 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.

Drug abuse, depression, anxiety, and suicidal thoughts are some of the things that women experience after they have aborted a child through chemical abortion drugs.

Defendants contend that plaintiffs’ theories of standing “depend upon layer after layer of speculation.” The lawsuits claim that F.D.A.’s chemical abortion regimen caused a number of serious side effects and medical problems for their patients.

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.

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.” 18 U.S.C. § 1461 (emphasis added). It is clear that abortion drugs are both drug and a way to produce abortion. Therefore, federal criminal law declares they are “nonmailable.”

Regulatory Uncertainty and the Impact on Pharmaceutical Research and Manufacturers: High Court Cases in Danco vs. State and Local Laws

Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely reduce incentives for investment, endangering the innovation that characterizes our industry. Some of them are executives of drug companies.

The Pharmaceutical Research and manufacturers of America are not a party to this litigation, but they want their policy environment to support the agency’s ability to regulate and provide access to FDA-approved medicines.

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.

In a letter to the Attorney General, the Principal Deputy Assistant Attorney General stated that the harm would be felt all over the country.

“These questions of whether the plaintiffs have the kind of real-world injury that is necessary to get into court, and whether their claim was timely or filed too late apply across the board in federal lawsuits,” said Supreme Court litigator Andrew Pincus.

“There are serious questions on whether the Supreme Court is willing to endorse the district’s court’s very broad approach to those questions,” he said.

The high court could see this case as less about abortion, and more about the authority of a federal agency to assess public health and the regulatory landscape in general.

Steve Vladeck, a CNN Supreme Court analyst and a professor at the University of Texas School of Law, said that the current conservative majority is very skeptical of how much authority various agencies have. An agency’s authority is predicated on long settled technical and scientific expertise and is the one place where they have been less skeptical.

The appeals court ruling against the decision of US District Judge Matthew Kacsmaryk on the prescription drug mifepristone

The word used by Kacsmaryk is “unborn human.” He refers to abortion as medication abortion, a term that is favored by opponents of abortion rights.

At other times his language is graphic. Kacsmaryk writes that the effects of mifepristone end nutrition and eventually starve the unborn human to death.

“Restricted access to this safe therapeutic threatens the health of real people – people who are mothers, sisters, daughters, wives and friends,” she wrote.

“Okay, so to recap the judge asserts that ‘fourteen percent of women and girls report having received insufficient information’ without revealing the entire sample consists of anonymous blog posts on pro-life website designed for women who regret their abortions,” Unikowsky wrote.

Some conservatives criticized the decision. According to Adam Liptak, legal scholars he interviewed described the decision of Kacsmaryk as being of poor quality and breathtaking sweep.

Now that the filings have been submitted, the US 5th Circuit Court of Appeals Court could rule at any time on whether to put a hold on the order from US District Judge Matthew Kacsmaryk.

The FDA’s approval of medication abortion drugs may be suspended if the appeals court doesn’t freeze the judge’s ruling.

The Justice Department filing pushed back on the assertions by the challengers, made in their filing overnight in the emergency dispute, that the 5th Circuit did not have the authority to hear the appeal of Kacsmaryk’s ruling. The Justice Department slammed Kacsmaryk and the challengers for relying on anonymous posts to say that mifepristone is unsafe.