Abortion Pill Legal Fight Leaves FDA Grappling With Response

The US Supreme Court’s decision to send back to a lower court a fight over the FDA approval of a widely used abortion pill tees up complicated legal questions over politicized medical treatments and the federal government’s authority over them.

In blocking lower court bans on the abortion drug mifepristone for the duration of a legal battle over the drug’s availability, the Supreme Court has allowed lower courts to scrutinize the process the FDA used to approve the drug 23 years ago and whether a century-old federal law prohibits the distribution of the abortion pill mifepristone by mail.

In his dissent, Justice Samuel Alito also shone a spotlight on the Food and Drug Administration’s enforcement discretion and questioned the agency’s ability to comply with any court orders on the pill.

That, along with other litigation over mifepristone playing out in federal courts in Washington state and West Virginia, leaves an uncertain legal environment for the FDA and the products it regulates.

On the same day District Judge Matthew J. Kacsmaryk in Texas issued his decision that sought to overturn the FDA’s approval, a federal judge in Washington ruled the agency couldn’t impose additional restrictions on mifepristone beyond the requirements in the agency’s existing safety program, including that prescribers and pharmacies are certified to dispense the pill.

Judge Thomas O. Rice of the US District Court for the Eastern District of Washington on April 21 denied a request by Idaho, Texas, and five other Republican-leaning states to intervene in that case, ruling that it wouldn’t prevent those states from implementing their own laws on medication abortion.

As arguments over mifepristone work through the courts, the judicial process should “look at the underlying circumstances very carefully, both the standing of the individuals who brought the suit,” and “the merits of the case in terms of the distortions about the underlying process by which the drug was approved,” former FDA Commissioner Margaret A. Hamburg said in an interview.

“It’s very dangerous when you start having individuals, political organizations, entities with vested interest in different kinds of being able to upend a well-established process that has been defined in law in practice over many, many years,” Hamburg said.

Enforcement Discretion

If mifepristone’s approval ultimately is overturned by the courts, attorneys and analysts say the FDA is protected in exercising discretion over whether to take enforcement action on the continued distribution and prescribing of the pill.

If risk for patients is considered low, the FDA can opt not to enforce certain requirements against a product.

Alito in his April 21 dissent disputed that Danco Laboratories, the brand-name manufacturer of mifepristone, couldn’t continue to market its drug unless it “jumped through a series of regulatory steps that would be largely perfunctory under present circumstances.”

“That would not take place, however, unless the FDA elected to use its enforcement discretion to stop Danco, and the applicants’ papers do not provide any reason to believe the FDA would make that choice,” Alito wrote.

He added that “the Government has not dispelled legitimate doubts that it would even obey an unfavorable order in these cases, much less that it would choose to take enforcement actions to which it has strong objections.”

Exercising discretion over enforcement actions is also different from deliberately ignoring a court order, said Rachel Rebouché, dean of Temple University’s Beasley School of Law.

“There’s been some widespread conflation of discretion and defiance, so it is within the FDA’s authority to decide how to enforce actions against manufacturers and their distributors,” Rebouché said.

FDA Commissioner Robert M. Califf said in a Senate hearing April 19 on the agency’s fiscal 2024 budget request that the “FDA intends to comply with any court orders” on mifepristone.

Using discretion in the long term “may not be something that will give potentially regulated parties 100% confidence about what might happen to them,” Andrew J. Pincus, a visiting clinical lecturer in law at Yale Law School, said.

“Discretion can be exercised in one way, and then a different administration can change the way it feels in its enforcement discretion,” he said.

Comstock Act

Another area that remains uncertain for the FDA is how courts plan to interpret a provision of a 150-year-old federal law, the Comstock Act, that prohibits the mailing of items designed to induce an abortion.

The law states that any “article or thing designed, adapted, or intended for producing abortion” is “nonmailable.”

The law hasn’t been enforced for decades, and an assistant US attorney general in the Justice Department’s Office of Legal Counsel said in a Dec. 23 memo that federal law doesn’t prohibit the US Postal Service from mailing and delivering mifepristone or misoprostol, in part because the drugs could be used for other purposes like miscarriage management.

Abortion opponents maintain the law blocks the mailing of drugs for ending pregnancies. In its order on the Biden administration’s request to stay the Kacsmaryk ruling, the US Court of Appeals for the Fifth Circuit suggested it read the Comstock Act as blocking the mailing of mifepristone.

“Comstock is so sweeping, at least the interpretation of it that the anti-abortion lawyers have,” said Mary Ziegler, a law professor at the University of California Davis. Under this interpretation, Ziegler said, you can’t mail any drug or device intended for abortion, no exceptions, even if life is at risk.

Yet how the Comstock Act is ultimately applied “will most likely turn on how the Supreme Court rules, and, unfortunately, the Court has not yet indicated which way it will go,” Delia Deschaine, an attorney at Epstein Becker & Green specializing in FDA regulations, said in an email.

Should the plaintiffs in the Texas case, Alliance Defending Freedom, succeed, legal experts say the door would be open for interest groups and others to go after other drugs.

“We could see ADF or other groups using the Comstock Act to challenge the mailing of abortifacients or other drugs that the groups find morally offensive, including possibly HIV medication,” Deschaine said.

‘Ever-Changing Landscape’

While the Supreme Court’s stay helps maintain the status quo for patients and medical providers as litigation continues, there’s a patchwork of state and federal laws that is likely only going to grow more confusing, attorneys say.

“The ever-changing landscape of mifepristone’s approval, both brand and generic, has only made that compliance more complicated and therefore uncertain,” Deschaine said.

As Democratic-led states seek to broaden access to the abortion pill in the Washington case, generic mifepristone manufacturer GenBioPro is challenging West Virginia’s abortion ban, arguing that federal regulations on the pill preempt the state’s law. It adds that the state law violates the US Constitution’s commerce clause by interfering with interstate sales of an approved drug.

The US District Court for the Southern District of West Virginia said in an April 21 order that GenBioPro could proceed with its lawsuit regardless of decisions in the ADF case.

The GenBioPro case “could further complicate the compliance quandary as there could be three, or more, overlapping decisions regarding the approval of generic mifepristone,” Deschaine said.