Abortion Drug Access Limits Unclear as Fight Goes to High Court

A potential rollback of FDA moves to make the popular abortion drug mifepristone more widely available moved a step closer with the Fifth Circuit’s decision against expanded access to the medication.

US Food and Drug Administration regulations allowing mifepristone to be mailed, taken later in pregnancy, and prescribed by non-physician medical professionals were found likely to be unlawful Aug. 16 by the conservative US Court of Appeals for the Fifth Circuit. Now the legal battle is heading for the US Supreme Court, where it’s unclear whether the justices will allow the regulations to stand.

The Fifth Circuit is “trying to turn the clock back by more than two decades and reimpose the rules governing mifepristone when it was first approved,” in 2000, Jennifer Dalven, director of the ACLU Reproductive Freedom Project, said during an Aug. 16 call with reporters.

If the high court sides with the Fifth Circuit, the impact on the availability of mifepristone will depend largely on how the FDA, the drug’s manufacturers, and health providers choose to respond to the decision, said David S. Cohen, a Drexel University law professor.

Without mifepristone, health providers could solely rely on the other medication in what’s currently a two-drug regimen—misoprostol—which wouldn’t be restricted should the Fifth Circuit decision survive an appeal.

Health providers could prescribe drugs for uses beyond those for which they are approved—a common practice in medicine. If the Supreme Court orders the FDA restrictions to return to what they were prior to 2016, off-label prescribing could include offering the drug to patients beyond the seven-week gestation restriction in the FDA’s previous safety program.

It’s also unclear how the manufacturers of the brand-name and generic versions of mifepristone—Danco Laboratories LLC and GenBioPro Inc.—would update product labeling, as well as safety materials and processes, to follow the court’s order, said Joshua Oyster, a Ropes & Gray LLP life sciences regulatory & compliance partner.

Medical societies, including the American College of Obstetricians and Gynecologists, have recommended using an alternative dosing of misoprostol on its own if mifepristone becomes unavailable.

“Providers can prescribe off-label and we don’t know if they will, or how many will,” Cohen said. “The FDA can refuse to enforce certain of its requirements and we don’t know if it will. Danco can refuse to follow certain requirements and test the waters to see if the FDA is going to do anything.”

The FDA also can use its enforcement discretion in deciding whether to act against anyone who violates access restrictions.

“Just like police officers don’t have to arrest everyone who goes 56 miles an hour in a 55 mile an hour speed limit zone, the FDA doesn’t have to arrest every single entity or go after every single entity that violates various restrictions related to FDA law,” Cohen said.

The US Department of Justice and Danco have said they plan to appeal.

A prospective Supreme Court decision could go either way, legal experts say. Conservative Justices Samuel Alito and Clarence Thomas made their positions known last spring when they dissented from an emergency order allowing the regulations to stay in effect.

Health law analysts say curtailed abortion medication access would significantly burden abortion clinics in blue states, already overwhelmed from serving residents of states where the procedures are severely restricted. Abortion pill mailing services would largely be prevented from shipping medications.

“This would be a radical departure from the way that abortion is practiced,” said Greer Donley, a University of Pittsburgh law professor specializing in reproductive health. “We’re making it harder for people to access the best care. All this is going to do is harm patient safety.”

Loosening Restrictions

Before 2016, patients could only take mifepristone in the US up to seven weeks into pregnancy, and had to get the drug in person from a certified physician, then complete a follow-up visit after 14 days.

After an extensive review of safety and efficacy data, the FDA expanded mifepristone’s use to up to 10 weeks into gestation, and allowed any certified health providers to prescribe the drug.

In 2021, during the Covid-19 public health emergency, the FDA allowed mifepristone to be prescribed via telehealth and distributed by mail. Later that year, the FDA permanently removed the in-person dispensing requirement, because the latest evidence demonstrated the rule was no longer necessary for safety.

Judge Jennifer Walker Elrod, who wrote the Fifth Circuit’s majority opinion, “dismissed out of hand all of the studies that the FDA relied on in making its decisions,” said Rachel Rebouche, dean of Temple University’s Beasley School of Law.

The Alliance Defending Freedom, a legal advocacy group that challenged the FDA’s approval of mifepristone, hailed the court ruling as a win for the organization and for the safety of patients who take mifepristone.

The decision “puts the FDA on notice as well as gives women a reason to maybe think twice about taking mifepristone unsupervised, certainly through the mail,” Erin Hawley, ADF’s senior counsel and vice president of the Center for Life and regulatory practice, said on a Aug. 16 call with reporters.

Curtailed Access

The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization that there is no constitutional right to an abortion spurred a slew of state-level restrictions on reproductive health and multiple courtroom battles across the country.

The Fifth Circuit is “just adding to the logjam” spurred by a patchwork of state abortion restrictions since Dobbs, said Wendy Parmet, a Northeastern University law professor.

According to the Guttmacher Institute, over 40 states have a prohibition on abortion at some point during pregnancy. Thirteen states have an outright ban, according to the institute.

If upheld, the Fifth Circuit decision “will have this spillover into the nonrestrictive states,” Parmet said. “It’s going to make it more difficult there.”

That’s in part due to the popularity of the two-drug abortion medication regimen that includes mifepristone. Last year, the Guttmacher Institute noted that medication abortion accounted for over half of abortions in the US.

Nevertheless, patients will have to “increasingly rely on surgical abortions,” Parmet said. But easily going from one state to another for the procedure, Parmet added, “has proven to be exceptionally onerous and impossible for many people.”

The case is Alliance for Hippocratic Medicine v. US Food and Drug Administration, 5th Cir., No. 23-10362, 8/16/23.