Texas judge suspends FDA approval of abortion pill mifepristone

Keywords Appeals / FDA / Law / Pharmaceutical
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A federal judge in Texas blocked U.S. government approval of a key abortion medication Friday, siding with abortion foes in an unprecedented lawsuit and potentially upending nationwide access to the pill widely used to terminate pregnancies.

In a competing opinion late Friday, a federal judge in Washington state ruled in a separate case involving mifepristone that the drug is safe and effective. He ordered the Food and Drug Administration to preserve “the status quo” and retain access in the 17 states—along with the District—that are behind the lawsuit seeking to protect medication abortion.

It seems inevitable the issue will move to the Supreme Court, and the dueling opinions and appeals could make that sooner rather than later.

The highly anticipated ruling from Texas puts on hold the FDA’s approval of mifepristone, a medication first cleared for use in the United States in 2000. It was the first time a court ordered the FDA to remove a medication from the market despite opposition from the agency and the drug’s manufacturer. The ruling will not go into effect for seven days to give the government time to appeal.

U.S. District Judge Matthew J. Kacsmaryk, a nominee of President Donald Trump with long-held antiabortion views, agreed with the conservative groups seeking to reverse the FDA’s approval of mifepristone as safe and effective, including in states where abortion rights are protected.

“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.”

Biden administration officials said they were reviewing both decisions Friday to determine next steps. The pair of lawsuits followed the Supreme Court’s elimination of the constitutional right to abortion last June, which allowed states to outlaw or sharply restrict the procedure.

The dueling and complicated rulings would put pressure on the FDA and the Biden administration on how to enforce the new mandates set by these rulings.

Medication-induced abortion—the most common method of abortion in the United States—has become increasingly contentious since the high court overturned Roe v. Wade.

The Texas lawsuit was brought by the legal group Alliance Defending Freedom on behalf of antiabortion medical organizations and four doctors who say they have treated patients with mifepristone. It claims the FDA did not have the power to approve the drug—one of two medications that are used together to terminate a pregnancy—and takes issue with the agency’s easing of restrictions on the pill through the years.

Public health professionals and legal experts have denounced the lawsuit as unsupported by scientific evidence. The FDA has repeatedly found the two-step medication abortion protocol to be a safe and effective alternative to surgical abortions. The drug manufacturer, Danco Laboratories, and the Justice Department have called the plaintiff’s claims baseless.

But the challengers accused the FDA of choosing politics over science when it approved “chemical abortion drugs,” and of purposely ignoring what the plaintiffs claim are potentially harmful side effects.

In his ruling, Kacsmaryk was highly critical of the FDA’s decisions over the years to loosen restrictions on how the pill is administered and faulted the FDA for “lax reporting requirements.”

The FDA, he wrote, “took its chemical abortion regimen—which had already culminated in thousands of adverse events suffered by women and girls—and removed what little restrictions protected these women and girls.”

He found that suspending approval was in the public interest because of the drug’s potential side effects.

“Many women also experience intense psychological trauma and post-traumatic stress from excessive bleeding and from seeing the remains of their aborted children,” he wrote.

Throughout the ruling, Kacsmaryk uses language often invoked by the antiabortion movement, referring to abortion providers as “abortionists” and a fetus as an “unborn human.” Kacsmaryk, a conservative Christian with a long history of antiabortion views, issued the ruling on Good Friday.

Both sides made their cases to Kacsmaryk on March 15 during a four-hour hearing that focused on the technical aspects of federal drug regulation and FDA processes. Kacsmaryk seemed aware of the stakes and how historic this case could be, asking the lawyers about legal precedent and his authority to essentially override the FDA’s approval of a drug more than 20 years ago.

The plaintiffs alleged that the FDA wrongly approved mifepristone and that the drug has failed to meet the rigorous federal standards necessary to be prescribed to patients in the United States. Erik Baptist, a lawyer with Alliance Defending Freedom, portrayed the drug as dangerous, saying the “harm of chemical drugs knows no bounds.”

On the other side, lawyers for the government and Danco defended the approval process and said there is tremendous evidence that the pill is safe. When Kacsmaryk asked if the drug was still safe now that the FDA allows the pill to be administered without a doctor present, Justice Department lawyer Julie Straus Harris said the science is still conclusive.

The government and drug manufacturer also argued that the plaintiffs had no legal standing to proceed with the case because the antiabortion doctors cannot show direct harm from that decision.

“Plaintiffs spent less than one hour describing the irreparable harm to you,” Jessica Ellsworth, a lawyer representing Danco, told the judge. “That’s for good reason. They don’t have any.”

In a brief filed before the hearing, leading organizations of physicians and other public health professionals told Kacsmaryk that reversing FDA approval of mifepristone after 23 years would “cause profound and irreparable harm to patients across the country.” It would be the first time a court ordered the FDA to remove a medication from the market despite opposition from the agency and the drug’s manufacturer.

Most pregnancy terminations in the United States are now brought about by medication and have “an exceptionally low rate of complications,” the brief said.

In a two-step medication abortion, a patient first takes one mifepristone pill, which terminates the pregnancy. Approximately 24 hours later, the patient typically takes a four-pill dose of misoprostol, a drug introduced in 1973 to treat stomach ulcers, to soften the cervix and prompt contractions that expel the embryo or fetus. While misoprostol is widely used on its own to perform abortions around the world, studies show it is less effective than the two-step regimen, and usually causes more cramping and bleeding.

Without access to mifepristone, abortion clinics would have to either default to a misoprostol-only medication abortion protocol, or perform only surgical abortions. Providers said either scenario would result in massive upheaval as they try to enact new procedures, which some clinic owners fear may present legal hurdles. A few have been stockpiling mifepristone in anticipation of the ruling, hoping they would be permitted to distribute the pills they already have regardless of Kacsmaryk’s decision.

If clinics no longer have access to mifepristone, “there will be a huge amount of congestion and waiting,” Amy Hagstrom Miller, chief executive of Whole Woman’s Health, a network of abortion clinics, said in advance of the decision. “We may have to do whatever we can outside of the building so the majority of the space can be for procedures.”

For abortion providers in states where the procedure is legally protected, the lawsuit is an unsettling reminder that they are also vulnerable to abortion restrictions – from federal legislation, as well as nationwide injunctions.

In briefs filed as part of the challenge, legal scholars warned that any court decision taking mifepristone off the market also would have far-reaching consequences for other drugs considered safe and effective. Patients who rely on lifesaving medications could see their drugs removed from the market with little notice, they said.

“We are not aware of any case in which a court has removed a drug from the market over FDA’s objection,” said a brief filed on behalf of the FDA legal scholars.

As states have moved to restrict or ban abortion since last June, women have increasingly turned to using pills to terminate their pregnancies. Abortion opponents see the drugs as a threat to their efforts to ban abortion, and have been ramping up efforts to restrict their use, both in the courts and state legislatures.

The lawsuit targeted the FDA’s loosening of restrictions on the abortion pill, including the agency’s decision in 2016 to say the drug could be used through 10 weeks of pregnancy, up from the seven-week limit in the initial approval. The FDA took steps this year to ease access to the medication in states where its use is legal, allowing retail pharmacies to dispense the pills directly from doctors or by mail.

In a separate legal challenge on the opposite side of the issue, 12 Democratic state attorneys general sued the FDA in February in an effort to loosen restrictions on access to mifepristone, claiming that the agency has imposed “particularly burdensome” limits on distribution of the drug.

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