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Georgia’s Heartbeat Abortion Ban Tests FDA Limits on Pill Access

July 22, 2022, 9:25 AM

Georgia’s revived abortion law puts a new strain on people turning to medication to end pregnancies and adds to an ongoing battle over the boundaries between states and the federal government.

The Eleventh Circuit’s decision to let Georgia ban abortions after a fetal heartbeat is detected creates a thorny situation for people relying on mifepristone—a drug long ago approved by the Food and Drug Administration to terminate pregnancies up to 10 weeks. Many Georgians are now effectively blocked from using the drug after the sixth week of pregnancy, even though that time frame is allowed under FDA regulation, attorneys say.

“It really will cut down the ability of Georgians to obtain an abortion of any kind,” said Rachel Rebouche, interim dean at Temple University’s Beasley School of Law.

Local officials, courts, advocacy groups and attorneys are struggling to make sense of an increasingly complicated legal landscape post-Roe, where access to pregnancy-ending services vary from state to state. Legal experts say the decision by the US Court of Appeals for the Eleventh Circuit marks the latest obstacle for people hoping to use medication to end a pregnancy.

“Medication abortion’s still legal before six weeks. Of course, that’s a very narrow time frame,” Rebouche said. “You would essentially need to know immediately that you were pregnant.”

‘Playing Games With People’s Lives’

In reversing the lower court’s injunction, the Eleventh Circuit took the unusual move of allowing Georgia’s abortion ban to immediately take effect rather than waiting the usual 28 days for enforcement.

Georgia residents with plans for an abortion already underway are now put in an “unnecessarily complicated situation,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project.

If “you’re going to be seven weeks and one day at the time of that visit, you now have to scrap that and figure out how you’re going to get to another provider in another state,” Moore said. “The courts and the politicians are playing games with people’s lives.”

The ruling will make it even more challenging for people seeking medication abortion, which accounted for roughly 42% of all abortions in the US as of 2019, according to the Centers for Disease Control and Prevention.

A federal district court in Mississippi is currently grappling with access to mifepristone in a case that could have ramifications on access nationwide. GenBioPro—the maker of a generic version of mifepristone—is urging a federal judge to rule that FDA prescription and dispensing regulations outweigh Mississippi’s stricter requirements.

A GenBioPro win could open the door to separate preemption challenges over abortion laws in Georgia and other states. But Georgia residents seeking mifepristone after the six-week cutoff may find themselves out of options in the current climate.

“When a state is able to ban abortions as Georgia is doing here, that’s going to apply to all abortions,” said Greer Donley, assistant law professor at the University of Pittsburgh’s School of Law. “Most states define it not by a particular means, but by any means of ending pregnancy.”

Often, state bans on abortion don’t prosecute a pregnant person, Donley said, leaving “somewhat of a loophole,” for someone using an abortion pill. That, however, is far from “a purely risk-free activity,” as states can use other statutes to go after users of the pills, like feticide or child abuse laws.

Question of Enforcement

The degree of impact on patients may depend on how far Georgia officials go in enforcing the state abortion ban.

“States have not been very successful in stopping this use and possession and spread of other substances that are banned,” said Wendy Parmet, director of Northeastern University’s Center for Health Policy and Law. “I remain dubious that they’re going to really be able to stop the use of this.”

It’s unclear whether states would want to build up “the kind of police surveillance state that would be necessary” to curb access to pills, Parmet said. From a legal standpoint, however, the Eleventh Circuit’s opinion suggests it’ll be difficult to convince some courts that FDA regulations preempt state restrictions, raising a host of new questions in the process.

“Can the state ban interstate importation? Can the state go after out-of-staters who are shipping abortion medications into a state?” Parmet asked.

“We are at the first stage of a tsunami of litigation,” she said.

To contact the reporters on this story: Ian Lopez in Washington at ilopez@bloomberglaw.com; Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Karl Hardy at khardy@bloomberglaw.com