A Texas Judge Suspends FDA Approval of An Abortion Pill

One federal judge blocked the drug’s approval by the U.S. government, while the other ruled that the pill should continue to be available in a number of states, casting doubt on the future of a crucial abortion medication on Friday night.

The conflicting rulings, one from Texas and the other from Washington state are in regard to access to mifepristone, the drug that is used in more than half of all US abortions. They come after the Supreme Court last year abolished the constitutional right to the operation. The top court will almost certainly hear the case; given the inconsistent rulings, this could happen sooner rather than later.

The Food and Drug Administration’s approval of mifepristone, which was approved for use in the United States in 2000, is put on hold by the highly anticipated and unprecedented Texas decision. For the first time, a judge overruled the FDA and the drug’s producer to revoke a medication’s long-standing approval. The decision won’t take effect for another week to give the government time to file an appeal.

The conservative groups attempting to rescind the FDA’s clearance of mifepristone as safe and effective, including in places where abortion rights are protected, were successful in getting U.S. District Judge Matthew J. Kacsmaryk to rule in their favor. Kacsmaryk is a nominee of President Donald Trump and has long espoused anti-abortion beliefs.

A Texas judge suspends FDA approval of an abortion pill

“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote in the 67-page opinion. “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.” He added that the agency had faced “significant political pressure” to “increase ‘access’ to chemical abortion.”

A federal judge in Washington state concluded that mifepristone is both safe and effective in a separate lawsuit involving it late on Friday. In response to the second case, which aims to defend medication abortion, U.S. District Judge Thomas O. Rice, who was appointed by President Barack Obama, ordered the FDA to maintain “the status quo” and access in the 17 states and Washington, D.C.

The Justice Department and pharmaceutical company Danco Laboratories submitted their notice of appeal shortly after the Texas decision. According to Attorney General Merrick Garland, the federal government will seek the U.S. Court of Appeals for the Fifth Circuit to permit the FDA to continue to approve the drug while the case is underway. 

In a statement released on Friday, President Biden condemned the Texas decision, saying that the court had “substituted its judgment for FDA, the expert agency that approves drugs.” Virtually no FDA-approved medicine would be safe from these types of political or ideological attacks if this verdict were to hold.

He referred to the choice as “another unprecedented step in depriving women of their basic freedoms and endangering their health.”

The FDA and the Biden administration will likely be under pressure to decide how to implement the additional requirements established by these verdicts due to the contradicting and complex findings.

No imminent change in the status quo is indicated by the judge’s decision in Texas to postpone his own judgment for a week while the administration seeks appeal in the 5th Circuit and the opposing decision in Washington state. But before taking the case to the Supreme Court, the Biden administration might not want to wait for the 5th Circuit to take a position.

It might request that Kacsmaryk’s ruling be suspended while the legal disputes are resolved. The justices might then have to choose between taking up the matter on an emergency basis or hearing it during regular business hours, which would require setting up a hearing for the new term that starts in October.

In certain recent cases, the court has taken that action. But it might create significant issues for a court that only has one round of oral arguments left in the current term, hasn’t delivered many opinions in cases that have already gone to trial, and hasn’t weighed in on the most important topics affecting the election law, affirmative action, religious freedom, and LGBTQ rights.

Since the high court reversed the almost 50-year-old Roe v. Wade ruling in June, allowing states to forbid or severely restrict the practice, medication-induced abortion has come under increased scrutiny.

The Texas verdict would not have an impact on their service for the following seven days, according to the abortion clinics who were contacted Friday night. Even Nevertheless, if Kacsmaryk’s decision is upheld, a number of healthcare professionals declared they would continue to provide mifepristone until given more instructions. 

A Texas judge suspends FDA approval of an abortion pill
A Texas judge suspends FDA approval of an abortion pill

For months, numerous abortion facilities have been getting ready for the Texas judgment. They assert that if they are required to stop offering mifepristone, they will continue to offer surgical abortions as well as, frequently, an alternative medication abortion regimen including simply misoprostol, the second pill in the typical two-step medication abortion regimen.

Less than an hour after the decision was made, at 6:51 p.m., Amy Hagstrom Miller, the CEO of the network of abortion clinics Whole Woman’s Health, texted a group of her workers, “Nothing changes for us tomorrow.”

Hagstrom Miller stated that Whole Woman’s Health will continue to recommend mifepristone until it receives instructions from the FDA.

Alliance Defending Freedom, a legal advocacy firm, filed the Texas case on behalf of four physicians who claim to have used mifepristone to treat patients as well as four anti-abortion medical organizations. It argued that the FDA lacked the authority to approve the drug and criticized the agency for loosening its regulations on the drug over time.

Erik Baptist, the senior counsel for the group, said in a statement on Friday that the FDA “never had the authority to approve these hazardous pharmaceuticals and eliminate crucial protections. The health and safety of women and girls, as well as the physicians and medical societies we represent, stand to gain significantly from this.

Legal and public health experts had criticized the lawsuit for lacking scientific backing. The FDA has determined time and time again that the two-step pharmaceutical abortion strategy is a secure and efficient substitute for surgical abortions. The Justice Department and medicine maker Danco have dismissed the plaintiff’s accusations as unfounded.

“This is a dark day for public health, especially reproductive rights and the reliance on science and medical expertise to guide decisions about what drugs are safe and effective and should be available to patients,” said Abby Long, director of public affairs at Danco, in response to the decision. “Fails to account for the meticulous, well-documented FDA decision-making process,” she claimed of the court’s decision.

The judge’s decision was “about as out-there as you can imagine,” according to Southern Methodist University law professor and FDA scholar Nathan Cortez.

Cortez, one of 19 FDA experts who signed an amicus brief supporting the agency’s stance that the pill had been properly approved, noted that the sources and terminology he references also read more like the opinion of an anti-abortion zealot than an objective judge.

“It cannot be overstated that courts simply do not override FDA’s determination of whether to approve new drugs and what restrictions to place on their marketing — and for a good reason: once again, most judges know these are incredibly complex decisions,” the author writes.

On March 15, Kacsmaryk heard arguments from both sides during a four-hour hearing that concentrated on the technical elements of FDA procedures and federal drug regulation. When Kacsmaryk questioned the attorneys about legal precedence and his ability to essentially reverse the FDA’s approval of medicine more than 20 years ago, he showed that he was aware of the stakes and how historic this case might be.

Three months after a case against mifepristone was filed in Texas, a complaint was filed in Washington state in February. Attorney General of Washington Bob Ferguson argued that there were too many limits placed on mifepristone by the FDA and requested that the judge compel the federal government to make the drug simpler for people to purchase.

MR.-Matthew-J.-Kacsmaryk

Even though these court cases are wholly unrelated to the one in Kacsmaryk’s Texas courtroom, they seem to at least partially refute that lawsuit. Ferguson stated that Washington was one of 21 states, along with D.C., that submitted a brief in the Texas abortion pill case pleading with Kascmaryk to uphold the FDA’s approval of the abortion pill in a press release announcing his lawsuit in February. In the end, Rice decided that the status quo must be maintained and did not force the FDA to lift any of its mifepristone restrictions.

A patient initially consumes one mifepristone pill, which ends the pregnancy, in a two-step pharmaceutical abortion. A four-pill dose of the 1973-introduced medication misoprostol is commonly used by the patient around 24 hours later to soften the cervix and trigger contractions that eject the embryo or fetus. Misoprostol is commonly used to induce abortions on its own all over the world, although studies suggest that it is less effective than the two-step procedure and typically results in more discomfort and bleeding.

 

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