Texas judge halts FDA approval of abortion pill

A Texas federal judge ruled Friday evening to suspend the FDA’s approval of mifepristone — one of two drugs used together to cause an abortion — virtually banning the sale of the pills across the country. The decision, however, will not take effect for a week, giving the Biden administration time to appeal, and delaying for now the impact on hundreds of thousands of patients who use the medication both for abortions and treating miscarriages.

U.S. District Court Judge Matthew Kacsmaryk in Amarillo, Texas, an appointee of former President Donald Trump, sided with anti-abortion medical groups that challenged the federal regulation of the drug, ruling that both the initial approval of the pills in 2000 as well as more recent FDA decisions allowing them to be prescribed via telemedicine, sent by mail, and dispensed at retail pharmacies are unlawful.

Kacsmaryk, hitting back at arguments that it was inappropriate to allow a challenge to a medication that have been approved for decades, wrote that "the FDA stonewalled judicial review" and "ignored" petitions from anti-abortion organizations to revisit the pills approval.

The judge's decision includes language commonly used by anti-abortion advocates, describing the intent of the pill as one "to kill the unborn human," referring to abortion providers as "abortionists," and describing the "intense psychological trauma" of people who use the pills and then see "the remains of their aborted children."

Roughly a quarter of states have banned nearly all abortions in the eight months since Roe v. Wade was overturned but this decision has the potential to affect pregnant people across the country — including in Democratic-controlled states that have prioritized abortion access.

The pills, which the FDA approved for use in the first 10 weeks of pregnancy more than two decades ago, recently became the most common method of abortion in the United States, and a way many people have circumvented state bans since the Supreme Court overturned Roe last June.

Both abortion-rights supporters and opponents have focused intensely on the pills in recent months — leading to clashes in state legislatures, regulatory agencies, and the courts.

The Biden administration, which is expected to quickly appeal to the right-leaning 5th U.S. Circuit Court of Appeals, has made defending the FDA's authority and maintaining access to the pills a top priority.

The DOJ did not immediately respond to a request for comment.

“We are vigorously defending the FDA in unprecedented litigation that is seeking to withdraw mifepristone from the marketplace, an action that would cause severe harm to all who rely on that medication,” Associate Attorney General Vanita Gupta told reporters in January. “The Justice Department is committed to doing everything we can to protect continued lawful access to abortion medication and other reproductive health services.”

The groups and individual doctors who brought the case argued that the FDA erred in its approval of the drug and didn’t adequately consider its safety risks.

“The adverse events from chemical abortion drugs can overwhelm the medical system and consume crucial limited medical resources, including blood for transfusions, physician time and attention, space in hospitals and medical centers, and other equipment and medicines,” the American Association of Pro-Life Obstetricians & Gynecologists, Christian Medical & Dental Associations and other organizations claimed in their suit. “The more patients suffering emergency complications from chemical abortion drugs or seeking to reverse the effects of the drug regimen, the less time and attention Plaintiff doctors have to treat their other patients.”

The Justice Department asked Kacsmaryk to dismiss the case, saying the doctors and medical groups have no standing and are attempting to “upend [the FDA’s] longstanding scientific determination based on speculative allegations of harm.” The DOJ also argued that the groups are well past the statute of limitations for challenging the 2000 approval of the pills, saying they can only legally go after the more recent agency actions that have loosened restrictions on how patients obtain them.

The 2021 and 2023 rule changes that allowed patients with a prescription to receive the pills by mail and pick them up at retail pharmacies were based on “multiple studies that showed that administration of the drug was associated with exceedingly low rates of serious adverse events,” DOJ argued to the court. The FDA first allowed telemedicine prescription of the pills just for the duration of the Covid-19 pandemic, and later moved to make the rules permanent based on new safety data.

Danco, the maker of the drug, has also intervened as a party in the case, arguing that the suit threatens “the company’s economic health.”

Some parts of the country could be hit particularly hard if the court-ordered ban takes effect. An analysis by the Guttmacher Institute, a pro-abortion-rights think tank, found that abortion clinics in two percent of U.S. counties only offer abortion pills and don't have a procedural option. Some of the states set to be most impacted — including Colorado, Pennsylvania and New Mexico — are serving their own residents and a large influx of patients from neighboring states with more restrictions. Guttmacher estimates the decision could impede access for at least 2.4 million people.

Some abortion providers have announced that they plan pivot to prescribing just the second pill in the two-pill regimen — misoprostol — in the event that mifepristone is banned. The drug is subject to fewer restrictions because it's used for many non-abortion purposes, including treating stomach ulcers. Misoprostol-only abortions are also common in other countries, but they have a slightly higher rate of patients requiring follow-up surgery to complete the abortion than the two pills used together.

"We've been preparing for the last few weeks, putting together updated policies and procedures that will go into effect should the ruling make mifepristone unavailable," Ashley Brink, the director of the Trust Women abortion clinic in Wichita, Kansas, told reporters in February. "We've held trainings for our doctors on how to counsel patients on what to expect and we've met with our attorneys about our legal exposure."

"However," she stressed, "not every clinic may be able to pivot as quickly to a misoprostol-only protocol."

If the decision banning mifepristone is allowed to stand, the FDA could move to approve it again if it receives a new application from the pharmaceutical company — a process that could take months if not years.

Abortion-rights advocacy groups also warn the decision could open the door to a wide range of ideologically motivated challenges to anything from birth control to vaccines.

“It basically puts at risk people’s access to medication that they rely on,” Carrie Flaxman, an attorney for Planned Parenthood, said in an interview. “This would allow anyone to come back decades later and claim a medication is unsafe.”