Federal choose upholds FDA abortion capsule approval, provides time for attraction

Abortion rights supporters gather in front of the J Marvin Jones Federal Building and Courthouse on March 15, 2023 in Amarillo, Texas.

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A federal judge in Texas on Friday suspended Food and Drug Administration approval for the abortion pill mifepristone statewide but delayed the ruling’s effective date by a week to give the Biden administration time to appeal.

But minutes after the Texas decision was announced, a Washington state federal judge issued an injunction that said essentially the opposite.

The seemingly conflicting rulings of the federal courts in the states of Texas and Washington mean the Supreme Court could ultimately weigh the legality of mifepristone in the US, which was approved by the FDA more than two decades ago in 2000.

When combined with another drug called misoprostol, mifepristone is the most common method of terminating a pregnancy in the United States, accounting for about half of all abortions.

US Judge Matthew Kacsmaryk of the US Northern District of Texas held a key hearing in the case weeks ago in Amarillo, but news of the decision, which could turn access to the key abortion drug, came late in the day Friday when many Americans were away religious observances.

Kacsmaryk supported almost all of the plaintiffs’ arguments in their right to sue, seeking to overturn the FDA’s approval of the drug. He argued that mifepristone had serious safety issues, overriding the FDA’s longstanding finding that the drug was safe and effective.

“The court does not lightly challenge FDA’s decision-making,” Kacsmaryk wrote. “But here the FDA has acknowledged its legitimate safety concerns – in breach of its legal duty – on the basis of patently unsound arguments and studies that did not support its conclusions.”

But in a dramatic twist, US District Judge Thomas Owen Rice for the Eastern District of Washington essentially countered the Texas decision when he barred the FDA from “changing the status quo and rights regarding the availability of mifepristone.” 17 states and DC that have sued to keep the pill on the market there.

Boxes of the drug mifepristone, used to induce a medical abortion, are prepared for patients at the Planned Parenthood Health Center in Birmingham, Alabama March 14, 2022.

Evelyn Hockstein Reuters

US Attorney General Merrick Garland said Kacsmaryk’s Texas ruling “overturns the FDA’s expert judgment, made more than two decades ago, that mifepristone is safe and effective.” Garland said the Justice Department will appeal the Texas ruling and defend the FDA approval.

In response to the Texas ruling, President Joe Biden said in a statement, “My administration will fight this ruling.”

“If this ruling stands, there will be virtually no FDA-approved prescription that would be safe from such political, ideological attack,” the president said.

The case goes to the US 5th Circuit Court of Appeals. If the Biden administration fails to persuade this court to overturn Kacsmaryk’s ruling, access to mifepristone across the United States would be jeopardized

But Washington State’s exclusion can protect access in at least Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, and Washington State direct current

Kacsmaryk’s decision will not affect access to misoprostol, which is widely used as a standalone abortion drug in other parts of the world. Some abortion providers have announced they will use misoprostol as an alternative to two-drug therapy if mifepristone is withdrawn from the market.

how it started

A coalition of anti-abortion doctors called the Alliance for Hippocratic Medicine sued the FDA in November over the approval of mifepristone. The group argued that the FDA abused its authority by fast-tracking mifepristone for new drugs that help patients with serious or life-threatening illnesses more than what is otherwise available on the market.

Kacsmaryk welcomed the group’s claims on Friday, arguing that pregnancy is not a disease and mifepristone offers no significant therapeutic benefit over surgical abortion.

The anti-abortion doctors were represented by attorneys from the Alliance Defending Freedom, an organization that worked with Mississippi lawmakers to draft the law at the center of the women’s health organization Dobbs v. Jackson. This case eventually led to the Supreme Court ruling Roe v. Wade picked up.

Kacsmaryk joined the court in 2019 after being appointed by former President Donald Trump. Kacsmaryk’s nomination was unanimously rejected by Senate Democrats and Maine Republican Susan Collins, who supports abortion rights.

His nomination was also rejected by abortion and LGBTQ rights organizations such as Planned Parenthood and the Human Rights Campaign.

The FDA called the case “extraordinary and unprecedented” in its January response to the lawsuit. Lawyers for the agency said they could not find any previous example of a court guessing after the fact of an FDA decision approving a drug.

The agency also said mifepristone was not approved through an accelerated route. It took more than four years from the initial application to the approval of the pill.

The FDA has approved mifepristone as a safe and effective method of terminating an early pregnancy based on extensive scientific evidence, the agency’s attorneys wrote. Decades of experience from thousands of women have confirmed that drug therapy is the safest option for many patients compared to surgical abortion or childbirth, the lawyers argued.

The FDA warned that withdrawing mifepristone from the US market would put women’s health at risk if they don’t have access to the pill to safely terminate pregnancies. It would also weaken the FDA’s powers for federal drug approvals and hamper drug development by creating regulatory uncertainty in the marketplace, government lawyers said.

“If long-standing FDA drug approvals were so easily waived decades after they were granted, pharmaceutical companies could not confidently rely on FDA approval decisions to develop the pharmaceutical drug infrastructure Americans depend on to treat a variety of health conditions,” he said the attorneys for the Biden administration wrote.

Mifepristone has been under FDA restrictions since its approval in 2000 to monitor the pill’s safety and effectiveness. These restrictions have been criticized and challenged by medical organizations such as the American College of Obstetricians and Gynecologists, and more recently by attorneys general in Democratic-ruled states.

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The FDA has gradually relaxed restrictions on mifepristone over the years as more and more evidence has been received. The agency dropped previous regulations that required in-person visits to healthcare professionals and allowed the pill to be delivered through the mail. The FDA recently allowed certified retail pharmacies to dispense mifepristone if the patient has a prescription from a healthcare provider approved under the agency’s surveillance program.

Misoprostol, the drug used with mifepristone, is recommended by the World Health Organization as a standalone method of abortion. But the FDA hasn’t approved misoprostol as the sole abortion drug.

The American College of Obstetricians and Gynecologists recommends misoprostol as an alternative for early abortions when mifepristone is unavailable, although it’s not as effective as the two-drug regimen, according to the organization.

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