Friday’s dueling decisions over a key abortion drug thrust the Food and Drug Administration into an unprecedented legal bind, imperiling its authority to approve and regulate medications, legal scholars said.
In Washington state, a federal judge ruled Friday that mifepristone is safe and effective, ordering the FDA to preserve access to the pill in the 17 states and D.C. that sued to protect medication abortion. But in Texas, another federal judge sided with antiabortion groups to block the agency’s approval of mifepristone, a decision that won’t go into effect for seven days, to give the federal government a chance to appeal.
“It is totally unclear how FDA is supposed to resolve this because this isn’t the way FDA does its job,” said Kirsten Moore, director of the advocacy organization Expanding Medication Abortion Access Project. “It shouldn’t have to say in these states the drug is approved, in these states the drug isn’t approved. That’s not tenable.”
The conflicting opinions probably mean a fast track for a legal showdown before a conservative Supreme Court that overturned the constitutional right to an abortion last June. If the high court were to uphold the ruling handed down by U.S. Judge Matthew J. Kacsmaryk in Texas, the FDA’s authority to vet and approve drugs, considered the gold standard around the world, could be permanently undermined, scholars said.
“This kind of Monday morning quarterbacking logic would allow courts to invalidate almost any FDA approval,” said Nathan Cortez, a law professor at Southern Methodist University, one of 19 legal experts who signed onto an amicus brief supporting the agency’s position that the pill had been properly approved in 2000.
The long-awaited Texas ruling comes nearly five months after an antiabortion group filed a lawsuit asking the conservative judge to rescind the approval of mifepristone, one of two drugs used in medication abortions. The suit was filed by Alliance Defending Freedom, a conservative legal group that argued the FDA rushed the drug’s approval, failing to properly study health concerns over mifepristone, which it claims is dangerous despite a decades-long track record of safe use. The suit was filed on behalf of four antiabortion medical organization and four doctors.
The FDA said in a statement Friday that it would appeal the decision.
“FDA stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications that FDA has determined to be safe and effective for their intended uses,” the agency said.
Ameet Sarpatwari, an expert on pharmaceutical policy and law at Harvard Medical School, said Kacsmaryk’s ruling is likely to encourage a spate of additional challenges.
“This opens the door to the courts’ second-guessing any FDA approval — especially for drugs for controversial areas like gender-affirming care, or PrEP for HIV prevention.”
He argued it would also instill uncertainty in the pharmaceutical industry. “This should worry every manufacturer out there,” he said. “They are now not assured of a uniform market for their drug based on FDA approval.”
President Biden expressed similar concern that Kacsmaryk’s decision would undermine the agency’s ability to approve medications Americans rely on every day.
“If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks,” he said in a statement.
The agency, in 2000, approved mifepristone, which was first introduced for medication abortion in the late 1980s in France. Used along with another drug, misoprostol, it essentially causes a miscarriage. Even before the Supreme Court overturned Roe v. Wade, medication abortion accounted for more than 50 percent of legal abortions in the country. In the United States, the standard protocol is to take the two drugs together — a single pill of mifepristone to prevent a pregnancy from progressing, and then a four-pill dose of misoprostol, about 24 hours later, to prompt contractions.
In his 67-page ruling, Kacsmaryk adopted the plaintiff’s legal arguments, chiefly that FDA failed to properly consider concerns about the safety of the medication.
The lawsuit claimed the FDA improperly used a set of regulations known as “Subpart H,” which allow for faster approvals and tighter regulations for drugs intended to “treat serious or life-threatening illnesses,” and provide a “meaningful therapeutic benefit” over existing treatments. Alliance Defending Freedom insisted that pregnancy isn’t an illness. The government countered that the FDA did not use an “accelerated” approval and its own regulations say the process could be used for a serious or life-threatening “condition.”
Kacsmaryk rejected that argument. “True, complications can arise during pregnancy, and said complications can be serious or life-threatening,” he wrote. “But that does not make pregnancy itself an illness.”
Lewis Grossman, a professor at American University Washington College of Law, who co-authored the amicus brief backing the FDA, said the judge’s ruling that the 2000 approval was invalid “makes no sense” because the agency re-approved the drug multiple times in the ensuing years.
Kacsmaryk also suggested that the FDA acquiesced to political pressure by failing to “evaluate the psychological effects of the drug,” or its long-term medical consequences — a critique that was pilloried by medical and regulatory experts.
“The court’s belief in its own scientific and medical expertise is breathtaking,” said Scott Lassman, a D.C. attorney who specializes in FDA regulatory issues. “I was particularly struck by the court’s conclusion that FDA should have required transvaginal ultrasounds as a condition to using mifepristone, as if the court is qualified to second-guess FDA’s contrary medical decision.”
The judge did not outright ban the medication or order the FDA to take it off the market, however, a process that generally takes months or years if the manufacturer disagrees. The manufacturer, Danco Laboratories, asked to intervene in the case and sided with the government in opposing the lawsuit.
The claims made by Alliance Defending Freedom also received pushback from abortion providers, Biden officials and some legal experts. Leading medical organizations — such as the American Medical Association and the American College of Obstetricians and Gynecologists — say “robust evidence” accumulated over years shows the drug is safe and effective.
Even before the dueling opinions Friday, experts had gamed out different strategies for the FDA. In a February column in Slate, several law professors wrote that whatever Kacsmaryk ruled, the agency could keep mifepristone on the market using its “broad enforcement discretion” when a drug’s safety risk is low. But other legal experts say they would be surprised if the Biden administration defied a federal judge.
The opposing opinion handed down by U.S. District Judge Thomas Rice in Spokane added a glaring new wrinkle.
In that case, state attorneys general from 17 states and D.C. argued that the FDA had imposed too many restrictions on mifepristone. Rice did not order the agency to roll back any of those restrictions but ruled the status quo must remain in force.
Jennifer Oliva, a law professor at the University of California College of the Law at San Francisco who also signed onto the amicus brief, said the agency cannot comply with conflicting orders.
“The Texas decision renders mifepristone an unapproved drug in seven days, but the Washington order says the FDA cannot alter the status quo,” she said. “So the best — and really only — choice here is for FDA to exercise enforcement discretion: that is, not enforce the Texas order, and not go after anyone for mifepristone distribution until the conflict is resolved.”
But political pressure from abortion rights advocates, especially heading into a presidential campaign season, could build on the FDA to make use of its enforcement discretion.
“No matter what happens in seven days, I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I’m again calling on President Biden and the FDA to do just that,” Sen. Ron Wyden (D-Ore.) said in a statement shortly after the ruling came down.