Abortion Pill Control Lies With FDA as Court Fight Tests Agency

Mifepristone access in the US hinges on how the FDA handles conflicting court rulings over the abortion medication’s availability, as a litigation battle plays out with significant implications for the extent of federal agency authority.

Legal experts say a Texas federal judge’s suspension of a Food and Drug Administration drug approval coming alongside another court’s demand that the agency maintain the product’s access presents an unprecedented situation for the federal government.

The FDA sits in the crosshairs. The agency has the ultimate say in how to respond to the court decisions, the outcomes of which could very well end up before the Supreme Court.

The dueling decisions, attorneys say, leave the FDA with the ability to maintain the status quo and keep access to abortion medications while the appeals process plays out. At the core of the cases are questions over federal agency authority and judicial reach that are being taken to unprecedented lengths, attorneys say.

The Biden administration has already filed its notice of appeal with the US Court of Appeals for the Fifth Circuit, a court widely viewed as among the nation’s most conservative. The administration likewise on Monday filed a request with the Fifth Circuit asking it to suspend the Texas ruling. Attorneys say that legally questionable arguments in the Texas decision, an unprecedented attack on FDA authority, and circuit precedent make it tough to predict how the appellate court might handle the case.

In the interim, however, legal experts say the conflicting rulings could block the FDA from changing the status quo. They also note that the decision leaves room for the FDA to refuse to enforce restrictions on mifepristone and for the agency to explore new ways to quickly approve the drug and get around the Texas ruling.

“The FDA doesn’t have to say or do anything,” said Rachel Rebouché, dean of Temple University’s Beasley School of Law.

Agency Authority

In his Friday order, Republican-appointed Judge Matthew Kacsmaryk wrote that the FDA went beyond its authority when it first approved mifepristone for use decades ago.

He wrote that the agency was under political pressure, and that the agency 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.

The Texas decision marks “a huge departure” for a court questioning agency authority, said Michael Ulrich, assistant professor of health law, ethics, and human rights at Boston University.

“It does get to this point of, can and should judges not be ruling merely on legal aspects—did an agency go through the right procedural steps, is it acting within the scope of its congressional authority,” Ulrich said. “That is extremely problematic for all agency actions.”

Litigants have long turned to the courts to challenge the scope of authority for government agencies.

The Texas case, however, marks “an interesting reversal of the way the debate over agency authority usually occurs,” said Leon Rodriguez, a former Health and Human Services Department official in the Obama administration.

Normally, a company will claim an agency overreached when it inhibits a business interest, Rodriguez said. But the Texas decision is “a sort of a realignment of the usual suspects, because here you have very conservative, very right-leaning plaintiff, and a right-leaning judge, arguing that the agency didn’t scrutinize enough, that it wasn’t tough enough,” he said.

Should this ruling stand, Rebouche said it would mark a “significant encouragement” for challenging FDA authority.

“What is to stop any litigant from forum shopping a judge to undercut the FDA’s approval of another drug based on its own assessment of safety and efficacy?” she added.

Creating Conflict

The Fifth Circuit will decide the Biden administration’s appeal of the lower court’s ruling.

Given the documented safety history of mifepristone, the Fifth Circuit may find itself in “a very intellectual awkward position” should it try to uphold the entire Kacsmaryk decision, she said.

Meanwhile, the conflicting Washington decision, also released Friday, said the FDA can’t change the way it regulates the drug.

On Monday, the Biden administration filed a motion asking the Washington court for guidance, noting the Texas order “appears to be in significant tension with this Court’s order prohibiting FDA from ‘altering the status quo and rights as it relates to the availability of Mifepristone’ in Plaintiff States.”

“The Court did not address the interaction between the two orders, presumably because they were issued less than 20 minutes apart,” the administration said. “To ensure that Defendants comply with all court orders in these unusual circumstances, Defendants respectfully request that this Court clarify their obligations under its preliminary injunction in the event that the Alliance order takes effect and stays the approval of mifepristone.”

This conflict gives “the FDA a very credible stance to say look, we kind of have to leave things as they are,” Ulrich said.

Enforcement Discretion

While the conflicting court orders stand, legal experts note that the ultimate authority as to how to proceed rests with the FDA.

The only way for the FDA to comply with both orders is by deciding against enforcement, said Greer Donley, an associate professor who specializes in abortion law at the University of Pittsburgh.

“This particular decision in Texas does not purport to force the agency to enforce the statute,” Donley said.

“Enforcement discretion is not ignoring the law, or ignoring what the court says is the law,” said David S. Cohen, a Drexel University law professor who focuses on the intersection of constitutional law and gender. “It’s just saying, ‘We are using our well-recognized discretion to enforce different parts of the law at different points in time. And we are not enforcing this law in this context. So we are not disagreeing with the judge that the approval is stayed.’”

Kacsmaryk’s order basically says that in seven days, mifepristone will become an unapproved drug, if the order isn’t halted by an appellate court. “The FDA doesn’t have to do anything for that to happen. It’s just going to happen,” she said.

The FDA has the option of either just not enforcing it, or taking a more formal step and issuing a notice that it will choose not to go after anyone for noncompliance, Donley said.

But Donley said an enforcement discretion notice would be much more useful.

“It would provide some safe harbor and some reliance for the industry that the FDA is not going to go after anyone. So I think that would be really reassuring to people who are providing this care,” she said.

—With assistance from Jeannie Baumann.