New Lawsuit Aims To Revoke FDA Approval Of Abortion Drug

Topline

Anti-abortion rights medical groups filed a federal lawsuit Friday seeking to overturn the government’s approval of abortion-inducing drugs mifepristone and misoprostol, potentially outlawing medication abortion as the pills have become increasingly important for abortion access in the wake of the Supreme Court overturning Roe v. Wade.

Dr. Franz Theard prepares doses of Mifepristone, the abortion pill, in his clinic in Santa Teresa, … [+] New Mexico on May 7.

The Washington Post via Getty Images

Key Facts

The lawsuit, filed in Texas against the Food and Drug Administration and Department of Health and Human Services, asks the court to withdraw FDA approval for the two drugs, which are used in combination to terminate a pregnancy, as well as decisions and regulations related to the medications that have been issued since they were first approved in 2000.

Plaintiffs argue the FDA did not have authority to approve the medications, as they were granted “accelerated approval” under a process meant for “serious or life-threatening illnesses,” which the plaintiffs argue shouldn’t apply to abortion-inducing drugs, and the plaintiffs claim abortion pills do not have a “meaningful therapeutic benefit” over other treatments as the FDA approval process required.

The lawsuit also alleges medication abortion carries “potentially serious and life-threatening effects,” though research studies and leading medical groups like the American College of Obstetricians and Gynecologists have repeatedly affirmed the safety and effectiveness of abortion-inducing drugs.

In addition to the FDA’s initial approval of the abortion-inducing drugs, the lawsuit also challenges subsequent orders that have expanded access to medication abortion, such as the agency’s decision in 2016 to allow medication abortion until 70 days into a pregnancy, rather than 49.

The lawsuit was filed by the Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians and Gynecologists, American College of Pediatrics and Christian Medical & Dental Associations, along with individual physicians.

The FDA and HHS have not yet responded to a request for comment, but an HHS spokesperson asserted the safety and effectiveness of medication abortion to the Wall Street Journal and said “denying women access to any essential care they need is downright dangerous.”

Crucial Quote

“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 argues. “And it has continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use.”

Big Number

54%. That’s the share of U.S. abortions that used abortion-inducing drugs in 2020, the most recent year for which data is available, according to research from the pro-abortion rights Guttmacher Institute.

Surprising Fact

This is the first major lawsuit that’s sought to remove an FDA-approved drug from the market, according to legal experts cited by the Journal, which first reported the lawsuit Friday.

Key Background

In medication abortions, mifepristone is used to stop a pregnancy, and misoprostol is then used to expel the pregnancy tissue after the pregnancy’s been terminated. The process, an alternative to surgical abortions, has attracted more attention in the wake of the Supreme Court overturning Roe v. Wade in June, with Google searches for the abortion pills spiking immediately after of the decision as states started banning the procedure and abortion clinics closed. Mobile abortion clinics have been dispensing abortion pills on the border of states where the procedure has been banned as a way of ensuring access, and mail delivery of abortion pills—which isn’t legal in many states, but bans are difficult to enforce—has been a primary way for people in states where abortion is outlawed to safely terminate their pregnancy. The Biden Administration has repeatedly pointed to the FDA’s approval of mifepristone and misoprostol as part of its argument against state-level abortion bans, with Attorney General Merrick Garland noting after the Supreme Court’s ruling that states cannot ban mifepristone because they disagree with the FDA’s approval of it.

What To Watch For

More lawsuits around medication abortion. There’s still a lot of legal gray areas around the dispensing of abortion pills in the wake of the Supreme Court overturning Roe v. Wade that have yet to play out in court, the Washington Post noted after the ruling, such as people who obtain abortion pills from other states and countries or use mail-forwarding services to have abortion pills shipped to a state where abortion is legal and then forwarded to them. The Biden Administration could also bring lawsuits against states that ban medication abortion in spite of the FDA’s approval of the drugs, though they’ve yet to do so. Pharmaceutical company GenBioPro, which manufactures mifepristone, filed a lawsuit in Mississippi challenging the state’s abortion ban on the basis of the drug’s federal approval. It ultimately withdrew the lawsuit after the Supreme Court’s ruling, citing the changed landscape on abortion, but has suggested it’s still planning a legal strategy to challenge state bans on abortion drugs in court.