Abortion Pill Hearing Tees Up Showdown on Access, FDA Authority

Abortion pill approval by the federal government will dominate courtroom arguments Wednesday between the Food and Drug Administration and physician groups in a case that will ultimately steer the course of reproductive rights in the US.

A three-judge panel from the US Court of Appeals for the Fifth Circuit will hear arguments over whether a lower court made the right call in overturning the FDA’s decades-long approval of the abortion medication mifepristone. Issued in April, the decision has spurred legal activity in several courtrooms, including the US Supreme Court, which has guaranteed access to the drug while the fight over its approval plays out at the Fifth Circuit.

The pharmaceutical industry and lawmakers have filed amicus briefs in the case, taking sides on divergent characterizations of the FDA’s approval and regulation of mifepristone, a drug used alongside misoprostol in the process known as medication abortion. Over half of U.S. abortions are medication abortions, which have become a prime target for abortion opponents since the overturning of Roe v. Wade in June.

The order by US District Judge Matthew Kacsmaryk appears to be the first time a judge has challenged an FDA drug approval and it has the potential to curtail abortion access across the country—even in states where the procedure remains legal.

The government will argue the physician groups behind the lawsuit have no standing to sue and that the agency’s regulation of mifepristone is supported by decades of evidence demonstrating the pill’s safety and efficacy.

Anti-abortion groups say the FDA used improper processes to approve the drug and should have sought additional evidence from safety studies.

The two sides in the case have “just radically different versions of mifepristone’s safety and the approval process that the FDA undertook,” said Rachel Rebouché, dean of Temple University’s Beasley School of Law.

“I’m curious to hear what the judges want to know in terms of that competing evidence because it’s important for the arguments on standing, and it’s important for the arguments about the FDA’s proper use of its power,” Rebouché said.

Anti-abortion advocates say the FDA’s actions, as well as prior outcomes in the legal battle, point in their favor.

“Already two courts have said that the Alliance for Hippocratic Medicine has a good chance of winning on the merits, which is why they granted a stay of the FDA’s reckless abortion pill regulations,” said Katie Daniel, state policy director for SBA Pro-Life America, in a statement. SBA Pro-Life America filed an amicus brief in the case.

“FDA approval of abortion pills was flawed from the start—that’s what this case is about,” Daniel said.

Arguments are set to begin at 1 p.m. CDT Wednesday.

Standing

The FDA plans to make the case to the appeals court panel that the anti-abortion groups haven’t suffered a clear injury from mifepristone’s approval, and thus don’t have standing to sue.

“The district court held that the associations have standing because some of their members might be asked to treat women who are prescribed mifepristone by other providers and who then suffer an exceedingly rare serious adverse event,” the agency said in its opening brief.

However, the Alliance for Hippocratic Medicine and other plaintiffs call the FDA’s view of standing “radical,” and that their theory “implies that only parties who profit from a drug—manufacturers and prescribers—can sue over its unlawful approval or deregulation.”

The company behind the abortion pill has waded into the fight as well. Danco Laboratories LLC told the court that the medical groups don’t have the standing to challenge the approval of a drug “they do not prescribe that is the standard of care for patients seeking a medical procedure they do not provide.”

Danco said the groups’ arguments “run headlong into black-letter [Administrative Procedure Act] law prohibiting courts from invoking their own views rather than reviewing whether FDA reasonably exercised its expert judgment and whether substantial evidence supports FDA’s finding of safety and efficacy.”

FDA Authority

In November 2022, The Alliance for Hippocratic Medicine, the American College of Pediatricians, Christian Medical & Dental Associations, and others sued the FDA in the US District Court for the Northern District of Texas, seeking a preliminary injunction to suspend the FDA’s approval of mifepristone and further distribution of the pill.

In April, Kacsmaryk suspended the FDA’s approval of the drug, ruling that the FDA overstepped its authority in approving the drug.

The “FDA acquiesced on its legitimate safety concerns—in violation of its statutory duty—based on plainly unsound reasoning and studies that did not support its conclusions,” Kacsmaryk wrote.

Shortly after, the Fifth Circuit partially granted the Biden administration’s request for an emergency stay, noting a challenge to the 2000 approval of mifepristone was barred by the statute of limitations. However, the appellate court kept in place Kacsmaryk’s block on more recent agency changes.

The Supreme Court eventually stepped in, ordering that the drug remain on the market until the court battle wraps up.

Now, the parties will argue whether the physician groups had the right to sue in the first place. The government says the physicians groups behind the suit haven’t suffered harm and that their claims have no basis under the Federal Food, Drug, and Cosmetic Act.

What’s more, the government argued, the lower court found that the “FDA’s actions were arbitrary and capricious, largely based on the court’s own interpretation of extra-record publications.”

The physician’s groups, meanwhile, allege the FDA’s calls are open for second guessing, noting that “no agency is infallible.”

The gist of the government’s “arguments is that FDA’s judgment was not based on the required scientific evidence. The agency’s position—that no court is worthy of checking FDA’s work—reeks of hubris and is contrary to the APA,” the physicians groups said.

‘Mandate from Congress’

Former FDA officials have filed their own brief in the case, claiming they are “qualified to explain how the district court fundamentally misunderstood the science of FDA’s approval and subsequent actions.”

They said the court “erred as a matter of law,” as “instead of reviewing FDA’s approval of mifepristone for reasonableness—as legally required—the district court substituted its own opinion regarding the correctness of FDA’s scientific analysis for the expert scientific judgments of FDA.”

The manufacturer of mifepristone’s generic version, GenBioPro Inc., isn’t an official party in the case, but filed its own brief arguing that a stay on its 2019 FDA approval “would put access to reproductive health care at risk for the hundreds of thousands of patients GenBioPro serves.”

The approval of the generic version “actually rests on an even more robust overall scientific database than the support that existed at the time of the original Mifeprex approval in 2000,” wrote GenBioPro, which supplies the majority of mifepristone in the US.

The pharmaceutical industry more broadly has come out in favor of the FDA as well.

In a brief filed alongside the Consumer Healthcare products Association and the National Association of Manufacturers, the Pharmaceutical Research and Manufacturers of America—or PhRMA—argued the Texas court decision isn’t reconcilable with the “FDA’s mandate from Congress” to greenlight what drugs hit the market.

“The district court erred by replacing FDA’s scientific judgments with its own views on what information should be considered and how it should be assessed. The district court compounded those errors by imposing its own extra-statutory requirements,” the brief said. “Congress clearly opted not to impose these requirements, and for good reason: They are contrary to well understood scientific methods and FDA’s correct exercise of its expertise.”

Members of Congress from both sides of the aisle echoed these arguments.

A Democratic-led coalition of more than 250 lawmakers wrote in a brief in the case that Congress gave the FDA the sole authority to approve drugs based on measurements of safety and effectiveness. Republicans argued in their own brief that the FDA in its approval of mifepristone “has subverted Congress’ public policy interests in patient safety.”

The case is Alliance for Hippocratic Medicine v. FDA, 5th Cir., No. 23-10362