Biden Admin Faces Sharp Questions From Conservative Appeals Court In Mifepristone Case

A conservative federal appeals court in New Orleans appeared highly skeptical Wednesday of the Biden administration's arguments for leaving intact the Food and Drug Administration's 2000 approval of a commonly used abortion pill, in a case that could disrupt the drug's availability nationwide.

Much of the two-hour-long arguments before Judges Jennifer Walker Elrod, James Ho and Cory Wilson focused on whether a group of anti-abortion medical associations and physicians had legal standing to challenge the FDA's 2000 approval of the drug, mifepristone, and subsequent actions from the agency that made the pill easier to obtain.

The medical groups and doctors claim that the FDA's green-light of mifepristone and steps taken since 2016 force them into situations where they must perform elective abortions in violation of their conscience rights. 

But Sarah Harrington, a Justice Department lawyer, told the judges that the agency's approval "doesn't require anyone to do anything," and the challengers cannot tie that approval to a cognizable injury. Additionally, it's "purely speculative" that the doctors would be forced to perform surgical abortions against their conscience due to a failed medication abortion, she said.

Wilson, a Trump appointee, suggested recent actions by the FDA to loosen the rules surrounding mifepristone have increased the likelihood that patients taking the drug will be forced to seek care from hospitals if they experience complications.

"It just strikes me that what the FDA has done in making this more available and doing it by mail-order and removing the doctor visits as well as the requirement that the prescriber be a doctor is you've made it much more likely that patients are going to go to emergency care or a medical clinic where these doctors is a member," he said. "I don't see how you square that circle." 

Still, the Justice Department argued that the panel of judges on the U.S. Court of Appeals for the 5th Circuit can resolve the case on threshold issues, as Harrington said the medical groups' challenge to the 2000 approval of mifepristone came outside a six-year statute of limitations and they lack standing to sue. 

Wilson pressed a lawyer for the anti-abortion groups on how their challenge to the 2000 approval is timely, suggesting the court may agree the challengers waited too long to target that action.

The battle over mifepristone

The case, Alliance for Hippocratic Medicine v. FDA, is closely watched given how the outcome could restrict access to medication abortion, including in states where it is legal. The legal dispute is one of the most significant involving abortion rights to follow the Supreme Court's decision last June that reversed the constitutional right to abortion.

Brought in November by a conservative legal organization on behalf of a group of anti-abortion medical associations and physicians, the plaintiffs argued the FDA erred in 2000 when it approved mifepristone, one of two drugs used in a medication abortion, and failed to adequately consider its safety.

In addition to pushing for the FDA's approval of mifepristone to be withdrawn, the medical groups and doctors sought to unwind a series of steps taken by the agency since 2016 that made the drug more easily available, including an expansion of the gestational age limit for using the drug from 7 weeks to 10 weeks, approval of a generic version of mifepristone in 2019 and removal of an in-person dispensing requirement in 2021.

A federal judge in Texas issued a temporary order in early April that said the FDA's approval of mifepristone should be suspended, kicking off a frenetic series of court orders that thrust the legal status of the abortion pill into uncertainty. Among those was a preliminary decision by the 5th Circuit that narrowed the district court's injunction, allowing mifepristone to remain on the market, but leaving in place portions that rolled back the FDA's changes since 2016.

The Supreme Court ultimately preserved full access to mifepristone while the appeals process plays out, though the case is almost certain to land before the justices again.

Before the 5th Circuit on Wednesday was the Justice Department's emergency appeal of the April 7 order from U.S. District Judge Matthew Kacsmaryk, a Trump appointee, that suspended the FDA's approval of mifepristone. 

Ho, also appointed by Trump, raised concerns with the process through which the FDA approved mifepristone, which involved a federal rule that allows accelerated approval of certain drugs that treat "serious or life-threatening illnesses." 

While it's understandable that an accelerated regime would be necessary for drugs treating cancer or AIDS, he said, "Why do you need to use that process here and does it even fit given that pregnancy almost certainly is not an illness?"

"When we celebrated Mother's Day, were we celebrating illness?" Ho asked Jessica Ellsworth, who represented Danco Laboratories, a drug company that makes mifepristone and submitted the original new drug application to the FDA in 1996.

The FDA, represented by the Justice Department, is urging the 5th Circuit to reverse Kacsmaryk's order, as Harrington said it is an "unprecedented and unjustified attack on FDA's scientific expertise."

There has been no court, she said, that has "vacated FDA's determination that a drug is safe to be on the market."

But Ho challenged that characterization as an "FDA-can-do-no-wrong theme" and said the FDA has on numerous occasions withdrawn drugs approved under the same rules as mifepristone.

"FDA is being blamed for the opioid crisis," he said. "It's a theme that you all are putting forth that is completely unnecessary. We are allowed to look at the FDA just like we're allowed to look at any agency, that's the role of the courts."

The FDA has stressed that more than 5 million Americans have taken mifepristone to end their early pregnancies, and medication abortions account for more than half of all abortions in the U.S. Serious adverse events associated with mifepristone are also "exceedingly rare," the Justice Department said in court filings.

But lawyers for the Alliance Defending Freedom, which is representing the medical groups, argue that the FDA "put politics above women's health" when it approved mifepristone in 2000 and removed certain requirements surrounding access to it, including allowing it to be dispensed through the mail.

Erin Hawley, a lawyer with the alliance, told the 5th Circuit that the doctors seeking to unwind the FDA's approval of mifepristone feel compelled to treat women who seek emergency care after taking mifepristone and are suffering harm in doing so.

"FDA acknowledges that emergency room doctors are going to be part of the solution in cleaning up the mess that's left for women suffering the consequences of a medical abortion," she said.

A decision against FDA would reach beyond states restricting abortion

The legal challenge targeting mifepristone and the FDA's 23-year-old approval of the drug opened a new front in the ongoing fight over abortion, and a decision against the agency would reach beyond the states that restrict abortion, as suspending its approval could mean the drug would be pulled off shelves nationwide. 

The FDA's backers are also sounding the alarm that if the district court's order is allowed to stand, it would undermine the agency's approval process for other drugs.

"The decision below sets the country on a dangerous path back to the piecemeal regulatory scheme that Congress rejected in 1938, when Congress decided that the best way to protect public health and promote access to safe and effective medication was to rely on an expert agency to regulate and approve drugs," a group of 13 former FDA officials wrote in a friend-of-the-court brief. "Courts lack the expertise to step into FDA's shoes by second-guessing FDA's experts on the safety and efficacy of drugs."

Also urging the 5th Circuit to reverse the district court's order are 240 congressional Democrats, who argued it has "no basis in law, threatens the congressionally mandated drug approval process, and poses a serious health risk" to pregnant patients.

"The district court's order not only misapplies the law but also threatens to harm members of the public, many of whom rely on the availability of mifepristone for reproductive care — and many more of whom rely on the integrity of FDA's drug approval process for continued access to life-improving and lifesaving drugs," they wrote in a court filing.

A group of 69 Republicans in Congress, however, told the 5th Circuit that it should leave the lower court's preliminary injunction in place, claiming the FDA contravened federal law and exceeded the scope of its authority from Congress.

"The FDA's unlawful approval and deregulation of chemical abortion drugs subverts Congress' public policy considerations and safeguards for patient safety," they argued in a friend-of-the-court brief.

First published on May 17, 2023 / 6:00 AM

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