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Merrick Garland’s Mention of the FDA Hints at One Possible Way to Fight Restrictions on Abortion Pills

On the heels of the Supreme Court decision that struck down the national right to abortion, Attorney General Merrick Garland issued a statement proclaiming that the Justice Department disagrees with the verdict. In addition to vowing to “work tirelessly to protect and advance reproductive freedom,” it indicated a potential avenue for the legal fight for abortion rights.

“[W]e stand ready to work with other arms of the federal government that seek to use their lawful authorities to protect and preserve access to reproductive care,” he said. “In particular, the FDA has approved the use of the medication Mifepristone. States may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”
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Jabin Botsford—The Washington Post/Getty ImagesAttorney General Merrick Garland at the Department of Justice on Tuesday, May 3, 2022 in Washington, DC.

Mifepristone has been approved by the U.S. Food and Drug Administration (FDA) for more than 20 years and is authorized for use during the first 10 weeks of pregnancy. It is taken in a regimen with the drug misoprostol and together the two drugs can safely induce an abortion. More than half of abortions in the U.S. are medication abortions.

Until recently, mifepristone had to be dispensed in person, but in December the FDA did away with the requirement, allowing the drug to be prescribed via telehealth and shipped by mail. While this change has expanded access to the drug, there has also been a push to reduce it. In September, for instance, Texas Governor Greg Abbott signed SB4, which banned abortion-inducing drugs after seven weeks and prohibited them from being mailed in the state. At least 19 states ban the use of telemedicine visits for medication abortion despite the FDA allowance, and many still require that a doctors prescribe the medication, even though the FDA does not.

Read More: What to Know About Abortion Pills Post-Roe

Garland’s mention of the FDA approval of the drug is a nod toward the federal preemption argument, says Rachel Rebouché, interim dean of Temple University Beasley School of Law. That argument is based on the premise that where federal and state laws conflict, the federal law prevails. In this case, that would mean a safety and efficacy determination by the FDA, a federal agency, would take precedence over a state’s tighter restrictions on a given drug.

But while it’s clear that states cannot legalize drugs that the FDA does not approve, explains Greer Donley, assistant professor at the University Pittsburgh Law School, the legal question here lies in the reverse scenario. “The argument is that FDA regulation of mifepristone is not only the national floor, which everybody accepts,” Donley says. “The question is whether the FDA’s regulation is also the national ceiling. Can a state regulate the drug more harshly than the federal government?”

Paul Ratje—The Washington Post/Getty ImagesDoses of Mifepristone, the abortion pill, and Misoprostol, which is taken the day after to cause cramping and bleeding to empty the uterus, are pictured at Dr. Franz Theards Womens Reproductive Clinic in Santa Teresa, New Mexico on May 7, 2022.

If a court were to decide FDA regulation is the national ceiling, and that no state may regulate drugs more strictly than the federal government, then even states with total state abortion bans – and, according to the Guttmacher Institute, 26 states are likely to or certain to ban abortion without Roe — would have to make exceptions for medical abortions.

For that reason, Donley was glad to hear Garland and President Joe Biden reference mifepristone in their responses to the Dobbs ruling. “It indicates that they are aware of the theory, and that they support it,” Donley says. “The question is whether or not they’re actually going to move forward and file a lawsuit, and whether they’re going to support these lawsuits moving forward.”

Read More: What the Supreme Court’s Abortion Decision Means for Your State

Medical abortions may be the next frontier of the legal fight for abortion rights across the country. GenBioPro, the generic manufacturer of mifepristone, had already filed a lawsuit based on the preemption argument in federal court against Mississippi for its ban on telemedicine for abortion. Earlier this month, the judge said he would consider waiting for the Supreme Court to issue its Dobbs ruling before deciding how to proceed.

Rebouché says she expects more people to turn their attention to mifepristone and the question of whether states can legally outlaw the use of abortion pills now that Roe has officially fallen. “Medication abortion is going to take up a lot of our thinking and time and advocacy on both sides of the question,” Rebouché adds. “I think what a lot of people are thinking is it’s a pretty key aspect to what abortion services actually look like moving forward.”

from TIME
via Time.com

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