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Conservative group sues FDA to revoke approval of abortion pill

A lawsuit suit claims the Food and Drug Administration lacked the authority to approve the drug mifepristone, did not adequately study the medication and that the drug is unsafe. (Allen G. Breed/AP)
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Abortion foes sued the Food and Drug Administration in federal court in Texas on Friday in an effort to reverse the agency’s decades-old approval of mifepristone, the drug used in medication abortions.

Alliance Defending Freedom, a conservative group that has been involved in antiabortion litigation, filed the suit in Amarillo on behalf of four antiabortion medical organizations and four doctors who had treated patients with the drug. The suit also named the Health and Human Services Department as a defendant.

The suit claims that the FDA lacked the authority to approve the drug, did not adequately study the medication and that the drug is unsafe. More than half the abortions in the United States are performed using mifepristone.

The “FDA failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States,” the lawsuit said. The suit said the agency erred in approving the drug under an expedited process that is intended to speed consideration of therapies for life-threatening illnesses, not a condition like pregnancy.

“Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit — they end a baby’s life and they pose serious and life-threatening complications to the mother,” Julie Marie Blake, Alliance Defending Freedom senior counsel, said in a statement.

Attorneys for Alliance Defending Freedom served on the legal team that helped defend Mississippi in the case that led the Supreme Court in June to strike down Roe v. Wade, which guaranteed the right to abortion.

The Biden administration and abortion rights advocates denounced the suit.

“For decades, women in this country have had access to FDA-approved medication abortion as a safe and effective option,” HHS said. “As [HHS Secretary Xavier Becerra] said, denying women access to any essential care they need is downright dangerous and extreme.”

The FDA said it does not comment on pending litigation.

Mifepristone blocks the hormone progesterone, which is needed to sustain a pregnancy. The FDA approved the medication as safe and effective through the first seven weeks of pregnancy about two decades ago, then later extended it to 10 weeks. The drug is sometimes used “off label” after that. Patients follow the use of mifepristone with misoprostol, which causes the uterus to empty.

Greer Donley, an associate professor of law at the University of Pittsburgh School of Law who has written extensively about the abortion pill, denounced the group’s safety claims as “ridiculous.”

“Mifepristone is one of the safest drugs on the market, safer than Viagra and penicillin,” Donley said. “We have a lot of studies and a lot of data on it.”

Donley said the legal claims in the suit were “really weak.” She said the agency approved the drug under the expedited procedure because it allowed the FDA to impose restrictions on its use — restrictions that she and other abortion rights advocates think should be eliminated.

Donley said she didn’t know of any other suit that has tried to undo the FDA’s approval of abortion medication.

Loren Colson, a family medicine physician in Idaho and fellow with Physicians for Reproductive Health, said mifepristone is “an incredibly safe medication.”

“It’s been well-studied and much safer than a lot of things you can find over the counter,” Colson said. “If they are trying to argue the safety, they have very little ground to stand on. It’s just a clear and blatant attack on abortion.”

The groups behind the Texas suit are the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians and the Christian Medical & Dental Associations.

Medication-induced abortion — the most common method of abortion in the United States — has become an increasingly contentious issue since Roe v. Wade was overturned in June.

As states have moved to restrict or ban abortion, women have increasingly turned to using abortion pills. Abortion rights advocates say abortion opponents see the drugs as a threat to their efforts to ban abortion.

State abortion bans are being interpreted as prohibitions on both medication and surgical abortions. Some of the bans are embroiled in legal battles.

The overturning of Roe v. Wade after nearly 50 years is expected to trigger a new set of legal challenges for which there is little precedent, observers say, further roiling the nation’s bitter political landscape and compounding chaos as Republican-led states move quickly to curtail access to reproductive care.

The Texas suit takes issue with the FDA’s easing of restrictions on the abortion pill through the years, including the agency’s decision in 2016 to say the drug could be used through 10 weeks of pregnancy. Last December, the FDA said it would allow abortion pills to be sent through the mail where permitted by state law. Previously, the pills could not be mailed, though that rule had been temporarily suspended because of the pandemic.

At the same time the FDA is being sued by abortion opponents, it also is being criticized by abortion rights advocates who say the agency is moving too slowly to lift remaining restrictions on access to the abortion pill.

Nine Democratic senators on Friday urged the agency to quickly finish up work to permanently allow mail-order delivery and to make other changes that would ease access to the drug.

In a letter to FDA Commissioner Robert M. Califf, the lawmakers said, “As states implement new restrictions, it is more important than ever that you take immediate steps to expand access to medication abortion.”