Implications of the Texas abortion decision on the Food and Drug Administration’s approval of mifepristone after the Supreme Court Overturned Roe V. Wade

The ruling by a federal judge in Texas last week revoking the Food and Drug Administration’s approval of the abortion pill mifepristone could be the most consequential abortion decision since the Supreme Court overturned Roe v. Wade in June.

The Supreme Court could be called upon to rule on the medication abortion controversy in the near future.

The opinion says that the anti-abortion organizations conducted a number of studies on the subject. A lot of studies have shown that medication abortion is very safe, with the chance of patients needing hospitalization in less than 1 percent of cases.

Jonathan Adler, a conservative law professor, and The Wall Street Journal’s editorial board also criticized the ruling. More than 400 pharmaceutical executives and investors condemned it as being “without regard for science or evidence” and dangerous to many future drug treatments.

The Fifth Circuit was asked by the Department of Justice to stay the decision pending the case being heard. In their request, the Justice Department lawyers argued that the district court upended decades of reliance by blocking FDA’s approval of the drug and that patients were unable to access it because of the court’s own misguided assessment of the safety.

Separately, the pill-manufacturer Danco, backing the FDA, said in a Monday filing that Kacsmaryk’s “relentlessly one-sided narrative … never mentions the millions of women who have benefitted from the availability of medication abortion or the harms an injunction would wreak on Danco, a one-product company.”

The key vote in favor of the decision was Justice Kavanaugh, who wrote a separate statement asserting that judges wouldn’t decide difficult moral and policy questions related to abortion.

The decision could still be appealed to the U.S. Supreme Court. In the meantime, Democratic leaders in states where abortion remains legal since the Supreme Court overturned Roe v. Wade last year say they are preparing in case mifepristone becomes restricted.

The decision from Kacsmaryk’s Amarillo courtroom more urgently drew the attention of Biden administration lawyers, drug manufacturers and abortion rights advocates.

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.”

Mifepristone and Misoprostol: Can the United States Abortion Pill Pill be Judged Criminally Incriminated?

DOJ lawyers argued that the medical groups did not have standing to suit because they did not have an actual injury and there were no allegations about harms to women and the medical profession.

Altogether, for those who take mifepristone “serious side effects occur in less than 1% of patients, and major adverse events—significant infection, blood loss, or hospitalization—occur in less than 0.3% of patients. The risk of death is almost non-existent.”

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.

According to reproductive health professionals, medication abortion, which is done in the first 12 weeks of the baby’s life, would still be possible in some form. Mifepristone might be sent from overseas, or the F.D.A. could decide not to take action against providers prescribing it. And some providers would switch to prescribing only the second abortion medication, misoprostol. But more patients would probably need to seek surgical abortions, and the ruling would create uncertainty and likely chaos throughout the country.

In the United States, the so-called abortion pill is actually two medications, mifepristone, sold under the brand names Mifeprex or Korlym, or known as RU-486, and misoprostol, which is taken about 24 to 48 hours later.

Both drugs work differently. Mifepristone blocks a hormone called progesterone, which the body needs for the pregnancy to continue. The hormone helps maintain the inside of the uterus, and without it, the uterus will expel its contents.

Misoprostol is approved by the FDA to prevent and treat gastric ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). It is used off-label for other types of ulcers, and it also has gynecological uses, including to decrease blood loss after delivery and to treat miscarriages.

On the Use of a One-Drug Approach to Abortion: After Six Years, Attorney General David Kacsmaryk Revisited

“It’s a little old-school, but we could do it,” said Dr. Kristyn Brandi, an ob/gyn and abortion provider in New Jersey and a spokesperson for the American College of Obstetricians and Gynecologists.

A person using this method is told to put four pills under their tongue, swallow them, and leave for 30 minutes. They can also be used vaginally.

Typically, bleeding will begin within one to four hours after the first dose. Heavy bleeding can last up to two weeks, although studies show it usually lasts less than five hours.

Again, it is safe. It is effective. It takes a different dose, so you experience the symptoms a little bit longer. “There are some other some additional side effects, like a longer duration of bleeding or more intense nausea or vomiting or gastrointestinal side effects, but when you look at that against the barriers that are put in place, both at the state and now the federal level for accessing abortion, many individuals still choose the second medication alone, because it is more convenient and easier, and it means you’re not walking through hundreds of protesters when you go to get care at your health care provider’s office.”

Dr. Iffath A. Hoskins, president of the American College of Obstetricians and Gynecologists, says that although the one-drug option is safe, people shouldn’t have to make that choice because a lot of research shows that the two drugs in combination are highly safe and effective.

We do use off label medications when clinically appropriate, but not here because we have over two decades worth of evidence based information that this is a valid option.

One of the points of contention is the statute of limitations to file a lawsuit challenging the approval of a drug which is six years. The F.D.A. loosened restrictions on the pill in 2016 before they removed the requirement for in-person consultation in 2021. The most recent decision is the only one within six years that the justice department says is still enough time to challenge it. Judge Kacsmaryk interpreted each change as restarting the clock to challenge approval for the drug.

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.

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.”

This strategy underwrote targeted regulations of abortion providers (TRAP laws), onerous clinic regulations and statutes forcing women to receive medically unnecessary and invasive vaginal ultrasounds. 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.

Complicated scientific arguments became more central to anti-abortion advocacy when the Supreme Court upheld the Partial-Birth Abortion Ban Act. In Gonzales v. Carhart, the court held that in circumstances of scientific uncertainty, legislators would have more latitude to regulate abortion. 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. The anti abortion group Students for Life of America is trying to get the FDA to rethink the approval of the drugs because of their questionable effects on the environment.

Women who have had an abortion are often left with feelings of shame, regret, anxiety, depression, drug abuse and suicidal thoughts.

The defendants contend that the theories of standing depend upon layers of speculation. The side effects of F.D.A.s chemical abortion regimen caused significant morbidity and injuries for patients requiring medical intervention and attention according to the lawsuit.

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.

Judge Kacsmaryk relies in part upon the Comstock Act, an 1873 anti-vice law that barred the mailing of contraceptives and “lewd” materials, along with drugs that could be used in an abortion. His strict interpretation of that statute conflicts with a December 2022 opinion by the Justice Department’s Office of Legal Counsel, which concluded that abortion-causing drugs could be sent by mail if the sender does not intend for the recipient to use them unlawfully.

Predicting what will happen at this point is speculative. “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.

Conservatives criticized the decision for that reason. My colleague Adam Liptak wrote that the legal scholars he interviewed described Kacsmaryk’s decision as being of “poor quality” and “breathtaking sweep.”

Kacsmaryk delayed the implementation of his decision for one week so that an appeals court would have time to review it. Depending on whether the judges assigned to the appeal are conservative or liberal will affect the outcome of the appeal. The Supreme Court is.

The Justice Department and a manufacturer of abortion pills have submitted the final round of court briefs in the emergency dispute over whether an appeals court should freeze a judge’s ruling that would suspend the Food and Drug Administration’s approval of medication abortion drugs.

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 took issue with Kacsmaryk and the others using anonymous blog posts to make a case for dangerous drugs.

Orders for Mifepristone from Massachusetts and Washington in a State with a Public Ordering Agreement, and the Patient’s Choice

In case access is disrupted, Massachusetts and Washington have announced that they will begin stockpiling Mifepristone. New York and California have Govs. who say their states are stocking up on the drug.

Anti-choice extremists have been working to dismantle our country’s reproductive health care system, which includes medication abortion and contraception, Hochul said. New York will always be a safe harbor for abortion, and I am taking action to protect abortion access in our State, and still lead the nation in defending the right to reproductive autonomy.

California said it shared the terms of its purchase agreement with other members of the Reproductive Freedom Alliance, a nonpartisan coalition of 21 governors who are committed to protecting reproductive rights, and who might also be interested in taking such action.

The governor’s office said last week that the university bought about 15,000 doses of mifepristone, enough to cover the commonwealth for about a year, and the pills are expected to arrive this week. Health care providers agreed to buy more and the government set aside a million dollars for it.

Inslee directed the state Department of Corrections – which has a pharmacy license and is legally able to buy medications – to buy the drug last month, he said, and the shipment was delivered March 31. The University of Washington also purchased 10,000 doses.

Demand for MIfepristone is up in all types of customers, the director of public affairs at Danco said. Massachusetts has requested an especially large number of pills from the company.

Orders for the drug have increased significantly in the last few months and are higher than they were last year, says Danco Laboratories.

Source: https://www.cnn.com/2023/04/12/health/abortion-drugs-stockpile/index.html

On the latest case of a federal appeals court ruling against access to an abortion drug in Maine and a similar nationwide order in Washington state

Maine Gov. Janet Mills, who called the Texas decision “reckless” and a “fundamental assault on women’s rights,” said Monday that her administration is evaluating its options, “including procuring mifepristone if needed, to protect access to medication abortion for Maine women.”

AUSTIN, Texas — A federal appeals court has preserved access to an abortion drug for now but under tighter rules that would allow the drug only to be dispensed up to seven weeks, not 10, and not by mail.

The appellate order was handed down by Circuit Judges Catharina Haynes, a George W. Bush nominee, and Kurt Engelhardt and Andrew Oldham, both Donald Trump nominees. Haynes, however, did not sign on to some aspects of the order.

The judge said she would have granted the expedited appeal but would have issued an administrative stay on Kacmsaryk’s ruling – a temporary hold that would have lasted a “brief period of time” – and deferred the question of whether it should be frozen longer term to the judges hearing the expedited appeal.

It’s unclear how the latest decision will interact with a ruling in a separate federal case in Washington state, filed by attorneys general from 17 states and the District of Columbia who are seeking to preserve access to the pills.

The motion filed Monday by the Justice Department asked Rice to clarify the meaning of his ruling because there appears to be tension with Kacsmaryk’s nationwide injunction.