What To Know About Mifepristone As Biden Administration Defends It From Legal Attack

Topline

Vice President Kamala Harris spoke out Friday in defense of the abortion pill mifepristone as an ongoing lawsuit could soon bar it from distribution nationwide, potentially taking away millions of Americans’ access to the medication as it’s become a more prominent abortion method in the wake of the Supreme Court overturning Roe v. Wade.

The abortion-inducing drug mifepristone can now be dispensed at pharmacies that choose to provide … [+] it, the FDA said Tuesday.

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Key Facts

Speaking at a White House meeting on access to reproductive healthcare, Harris denounced the “attempt to further attack fundamental rights to healthcare” by prohibiting abortion pills Friday, telling opponents they “ought to look in their own medicine cabinets” to see if they’re prepared to have FDA-approved drugs they use taken away, “because that’s what we’re talking about” if courts are allowed to revoke FDA approval of medications.

Mifepristone is one of two drugs that’s taken to terminate a pregnancy—it stops a pregnancy, and then a second drug, misoprostol, induces contractions to expel the tissue—and it is approved for use up to 10 weeks into a pregnancy, though in practice it’s often used until weeks 12 or 13.

The drug must be prescribed and cannot be obtained over the counter, and historically it’s only been available in-person from a physician or clinic certified to prescribe mifepristone, or more recently, prescribed through telehealth appointments and dispensed through mail-order pharmacies approved to supply the drug.

The Food and Drug Administration finalized regulations in January that now allow mifepristone to also be dispensed at brick-and-mortar retail pharmacies after being prescribed by a medical provider, after those pharmacies become certified to dispense it and agree to certain criteria.

Major retailers including CVS and Walgreens have largely agreed to carry mifepristone in states where abortion is legal, expanding access to the drug, though Walgreens caved to pressure by GOP officials in Kansas and said it wouldn’t carry the drug in the state, even though abortion is legal there.

Access to medication abortion is now being threatened by a lawsuit brought by anti-abortion advocates who believe the drug was unlawfully approved by the FDA and want its federal approval to be revoked, which could result in a nationwide injunction being soon issued that could block mifepristone from being prescribed and distributed nationwide, including in states where abortion remains legal.

Lawmakers in many GOP-led states have also introduced or floated legislation that could threaten access to medication abortion or punish people for using it, as pregnant people have been able to skirt state-level abortion bans by obtaining pills through the mail or traveling to nearby states.

What To Watch For

It’s unclear when a court ruling could come out that could block access to abortion pills. Briefing in the case is scheduled to end Friday, which means a ruling could come out at any point after, likely spurring the timing for Harris’ comments Friday. The judge hearing the case—a Trump appointee who’s been sympathetic to right-wing issues in the past—could first hold a hearing before issuing a decision, however. Any order would likely block the distribution of mifepristone temporarily while the litigation continues to play out, and it’s expected the Biden Administration would try to immediately appeal the ruling in an effort to stop it from taking effect. If the federal government fails and abortion access is banned, a study from pro-abortion rights group NARAL found an additional 40 million American women would lose access to abortion.

Big Number

53%. That’s the percentage of all abortions in the U.S. that were medication abortions in 2020, the most recent year for which data is available, according to the pro-abortion rights Guttmacher Institute. Research has consistently shown medication abortion to be highly safe and 99.6% effective in terminating a pregnancy, with only 0.4% of medical abortions resulting in serious complications. The FDA reports only 28 deaths have been reported in patients “associated with mifepristone” between September 2000 and June 2022, though it notes it’s not clear if those deaths were actually caused by mifepristone, as they may have been due to other factors.

Key Background

Medication abortion through mifepristone and misoprostol was first approved by the FDA in 2000. Though widely used even when abortion was legal throughout the U.S., the abortion drugs have gained attention in the wake of the Supreme Court overturning Roe v. Wade in June, as they’re an easier way for patients in states where the procedure is banned to more easily obtain an abortion as clinics providing surgical abortions have shut down. The wave of state-level bans on abortion has prompted new tactics to make abortion pills available, such as mail-order services—and mail-forwarding services that can help skirt state bans—and abortion providers setting up mobile clinics on the borders of states where abortion is outlawed. According to VICE News, more than 20,000 packets of abortion pills were shipped using covert methods in the six months after the Supreme Court’s decision in an attempt to circumvent state bans. The FDA’s expansion of mifepristone to retail pharmacies and the DOJ’s opinion on mailing the pills are part of the Biden Administration’s broader efforts to blunt the impact of the Supreme Court’s ruling, as the administration has pointed to medication abortion and the fact the FDA has authorized abortion pills for use nationwide as a key way of counteracting state bans.

Surprising Fact

The Justice Department clarified in January that abortion pill can be mailed to states where abortion is banned under federal law. Under the Comstock Act of 1873, which restricts the mailing of items used to “produc[e] abortions,” mifepristone can legally be mailed through the U.S. Postal Service or private carriers like UPS or FedEx, the DOJ said in a legal opinion, as long as the sender believes the drug will be used in a legal way. That could still be the case even in states where abortion is banned, such as if the pills are used for a medical emergency or if the drug is actually administered in a different state where abortion is legal, the Biden Administration said. That being said, while the DOJ’s opinion will serve as a legal shield to ward off challenges against abortion pills being mailed under federal law, it’s still possible that people who mail abortion pills could face legal repercussions under state laws. That’s particularly the case in states that specifically ban the mailing of abortion pills, such as Arizona, Indiana, Oklahoma and Texas.