Federal decide upholds FDA abortion capsule approval, offers 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 the Food and Drug Administration’s approval of the abortion pill mifepristone, but delayed the ruling by a week to give the Biden administration time to appeal.

Mifepristone was approved by the FDA more than 20 years ago. The much-anticipated ruling comes almost a year after the US Supreme Court overturned the constitutional right to abortion that had existed since the early 1970s.

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 on a Friday , when many Americans were traveling religious customs.

He supported nearly all of the plaintiffs’ right-to-law arguments seeking the revocation of FDA approval for the drug, and indicated that he believes the drug has serious safety issues, despite the evidence the defendants presented to the contrary.

Kacsmaryk argued that the FDA’s approval of mifepristone in 2000 was unlawful because the agency approved the drug under a provision for new drugs that offer significant therapeutic benefit over existing treatments for serious or life-threatening diseases.

Kacsmaryk argued that pregnancy is not a disease and that mifepristone offers no significant therapeutic benefit over surgical termination of pregnancy.

“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 Kacsmaryk balked at immediate drastic action, such as ordering the FDA to withdraw or suspend the approval. Instead, he paused on September 28, 2000, mifepristone’s approval date, and gave the Biden administration seven days to appeal his decision to the US 5th Circuit Court of Appeals.

In a dramatic twist, a Washington state federal judge issued an injunction minutes after the Texas decision was announced, saying essentially the opposite.

Judge Thomas Owen Rice of the U.S. District for the Eastern District of Washington barred the FDA from “altering the status quo and rights regarding the availability of mifepristone” in the states of the 18 attorneys general who sued to ensure that Mifepristone will remain on the market in these states.

The Food and Drug Administration, abortion pill maker Danco Laboratories and anti-abortion group Alliance Defending Freedom presented their arguments in front of Kacsmaryk in Amarillo, Texas weeks ago in March.

The alliance represents a coalition of anti-abortion doctors, the Alliance for Hippocratic Medicine, which in November sued the FDA over its approval of mifepristone. Approval goes back more than two decades to the year 2000.

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.

In its response, the FDA called the lawsuit “extraordinary and unprecedented.” 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.

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

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 become a central focus of abortion access litigation since the Conservative majority on the Supreme Court last June, Roe v. Wade fell. 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

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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