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Abortion Pill Access Will Remain Post-Roe: FDA Rules Explained

May 4, 2022, 9:46 AMUpdated: June 24, 2022, 7:01 PM

A pill used to end early pregnancies has gained focus leading up to the US Supreme Court’s decision overturning the landmark ruling that legalized abortion nationwide.

The majority decision, written by Justice Samuel Alito, overturns Roe v. Wade and the constitutional right it established. The ruling is likely to render the procedure largely illegal in half the US.

Pregnant individuals will still be able to access the pill mifepristone in states that don’t restrict it. The FDA’s regulation of the pill won’t change, but a patchwork of abortion laws could raise questions over states’ authority to impose restrictions that go beyond what the agency recommends.

Attorney General Merrick B. Garland said in a statement following the ruling that states “may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”

1. What is mifepristone?

Mifepristone, together with another medication called misoprostol, can be used to end a pregnancy within 70 days of a person’s last menstrual cycle, before the end of the first trimester. The brand-name version of mifepristone—Mifeprex—was approved by the FDA in 2000. In 2019, the agency approved a generic version of Mifeprex manufactured by Genbiopro Inc.

As of 2019, medication abortions accounted for roughly 42% of all abortions in the US, according to data from the Centers for Disease Control and Prevention.

Mifepristone is subject to a risk evaluation and mitigation strategy (REMS), a drug safety program that the FDA can use to make sure the benefits of a medication outweigh its risks. Under the program, the drug may only be prescribed by a certified health provider who must obtain a signed agreement from the patient after counseling and prior to prescribing.

The FDA previously mandated that the drug be administered in-person by a medical provider and then permanently removed the requirement in December 2021. That decision came after a review that determined the drug is still safe and effective when patients pick it up at pharmacies or by mail. The FDA earlier temporarily suspended the in-person dispensing requirement for the duration of the public health emergency.

2. How does the FDA regulate it?

The FDA regulates mifepristone, like all other drugs, under the authority given to it under the Federal Food, Drug, and Cosmetic Act. Any drug approved by the FDA must have evidence showing it’s effective at treating a particular disease or condition and that its benefits outweigh any potential safety risks.

The FDA also requires certain risk mitigation strategies on the label for mifepristone, such as that the drug be dispensed by certified pharmacies. Because the agency is only tasked with ensuring drugs on the US market are safe and effective for their targeted population, a Supreme Court ruling on abortion rights won’t prompt the FDA to alter its scientific review process.

An FDA spokesperson said that with Roe overturned, the agency “will continue to regulate mifepristone products for the medical termination of early pregnancy consistent with the Federal Food, Drug, and Cosmetic Act and applicable regulations.”

3. How can people get it without Roe?

Patients seeking an early abortion can still get mifepristone—but only from states with their own laws allowing it.

“State restrictions on abortion and those specific to mifepristone would remain in place in a post-Roe world, and access would remain in states that don’t restrict abortion,” according to Kate Connors, spokesperson for the American College of Obstetricians and Gynecologists.

While the FDA has defended the safety of abortion via telemedicine or mail order, 19 US states have laws requiring a clinician to be physically present when abortion-inducing drugs are administered, according to the Guttmacher Institute, a reproductive health-care research firm. Thirty-two states require clinicians who administer medication abortion pills to be physicians, and two states—Indiana and Texas—prohibit the use of medication abortion starting at a specific point in pregnancy.

People living in states with abortion restrictions could still get mifepristone through telemedicine from a doctor practicing in a different state.

“Virtual providers can continue to use the mail order option in states where abortion is legal,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project. “This will create more flexibility and openness for patients seeking time sensitive care in that state or with the means to travel to such states.”

Mifepristone manufacturer Danco Laboratories said after the ruling: “We maintain adequate inventories at all times and are fully prepared for any surge in demand.”

4. What issues might states see?

States allowing medication abortion will likely face increased demand from residents of other states—leading to interstate battles that could deter some providers from dispensing to certain patients.

“We’re basically going to live in a country that has a big patchwork of abortion laws,” Greer Donley, an assistant professor of law at the University of Pittsburgh School of Law, said. “If a provider in New York is mailing medication abortion to someone who lives in Alabama, Alabama is going to have a hard time reaching that person in New York even though that conduct is clearly illegal.”

States that have additional restrictions on mifepristone may also need to consider the potential for legal battles over their authority to put rules in place that go beyond those recommended by the FDA.

Abortion rights advocates could try challenging restrictive state laws on mifepristone based on the argument that federal laws and regulations preempt state law, Donley said.

To Learn More:

—From Bloomberg Law:

State Restraints on Abortion Pill Access Tee Up New Legal Battle

Abortion Pill Access to Ease With In-Person Pickup Rule Nixed

Demand for Abortion Pill Access Rises With Roe on Precipice

Abortion Pill Dispute Ends After in-Person Delivery Rule Lifted

—From Bloomberg News:

Supreme Court Overturns Roe, Transforming Abortion-Rights Fight

Overturning Roe Opens Door for Long-Dormant State Abortion Bans

Blue States Vow to Be Abortion Havens If Roe v. Wade Overturned

Supreme Court Draft Ruling Rejects Abortion Rights: Politico (1)

(Updates comment from FDA in the 11th paragraph.)

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Fawn Johnson at fjohnson@bloombergindustry.com; Cheryl Saenz at csaenz@bloombergindustry.com