Ethermac|A Trump-appointed Texas judge could force a major abortion pill off the market

A case before a federal judge in Texas could Ethermacdramatically alter abortion access in the United States – at least as much, some experts say, as the U.S. Supreme Court's Dobbs v. Jackson Women's Health Organization decision last year, which overturned decades of abortion-rights precedent.

A decision is expected soon in the case challenging the Food and Drug Administration's approval more than 20 years ago of the abortion drug mifepristone, which a growing number of patients use to terminate pregnancies.

Jenny Ma, senior counsel with the Center for Reproductive Rights, says the outcome of the suit brought by a coalition of individuals and groups opposed to abortion - could amount to a "nationwide ban on medication abortion" with a greater impact than Dobbs.

"That decision left the decision about abortion up to the states," Ma says, "but this would be one court in Texas deciding whether or not medication abortion could be allowed across this country, even in states that have protected abortion since the Dobbs decision."

Tiny pill, big impact

Medication abortion — as opposed to a surgical procedure — is now the most common way that people terminate pregnancies. That's especially true in the first trimester when the vast majority of abortions occur. Abortion pills are increasingly relied on by people who live in places where access to clinics is limited by state laws or geography.

While various regimens exist for terminating pregnancies with pills, the gold standard for medication abortion in the United States is a two-drug protocol that includes mifepristone and another, less-regulated drug, misoprostol.

But now, a coalition led by the anti-abortion rights group Alliance Defending Freedom has filed a lawsuit in federal court in Texas asking a judge to reverse that approval.

Revisiting a decades-old drug approval

The anti-abortion group is raising questions about the FDA's approval process in 2000 and some of the rule changes that have been made since then. They note that under President Biden, the FDA now allows mifepristone to be mailed or dispensed by retail pharmacies, while it used to be subject to more layers of restriction.

"They've loosened the requirements again, and again, and again," says Denise Harle, senior counsel with Alliance Defending Freedom. "So now, mifepristone is being given to women who have never even seen a physician in person."

Under the recent rule changes, it's now possible for patients to receive a prescription through telehealth in states where that's legal, an option that major medical groups support.

One judge, national implications

Normally, as the FDA has noted in its defense of its approval process, it would be unusual to pull a drug from the market after more than two decades of widespread safe and effective use.

That decision is now up to a federal judge in Texas, Matthew Kacsmaryk — a Trump appointee with longstanding affiliations with the religious right, including work as an attorney with a conservative Christian legal group based in the state.

"It's no accident that the complaint was filed in Amarillo, says Elizabeth Sepper, a University of Texas at Austin law professor.

"The way the district courts in Texas dole out cases makes it so that there are a few places where you pretty much know which judge you're going to get," Sepper says. "So they know they have a very sympathetic ear."

Any appeals in the case would go to the U.S. Court of Appeals for the Fifth Circuit – widely known as a conservative jurisdiction – and then to the U.S. Supreme Court.

Not just red states

If Judge Kacsmaryk sides with the anti-abortion group, mifepristone would have to be pulled from the market, at least temporarily. The FDA could choose to restart the approval process, which could take years.

Jenny Ma stresses that because this is a federal case, the impact could be felt nationwide, not only in states with abortion bans.

"After Dobbs, it almost seemed like there were two Americas – where abortion access was allowed in some states and not in others," Ma says. "This would amount to a nationwide ban on medication abortion, and patients who seek this care would not be able to get this care from any pharmacy, or any prescriber or any provider."

The judge has allowed additional time for the plaintiffs to respond to a brief filed by the drug's manufacturer. Sometime after that deadline, Feb. 24, the judge is expected to issue a decision or schedule a hearing.