Supreme Court’s Abortion Pill Call Leaves FDA in Line of Fire

The FDA faces a long road of litigation ahead in the abortion pill case that attorneys say threatens to upend the agency’s drug approval process.

The US Supreme Court on Friday blocked a Texas judge’s restrictions on the abortion pill mifepristone from taking effect, marking a temporary win for the Biden administration as it works to defend the Food and Drug Administration’s decades-old approval.

But attorneys say the agency’s fight isn’t over: The US Court of Appeals for the Fifth Circuit is scheduled to hear oral arguments in the case May 17.

The case is likely to wind up back at the Supreme Court, attorneys say. A dissenting opinion from Justice Samuel Alito criticizing the FDA’s responses to the litigation signals the heightened risk to what’s widely considered the agency’s “gold standard” of drug approvals, attorneys and analysts say.

That puts the agency at risk not only for political pressure, but lawsuits second-guessing its decision making on controversial drugs, including those used for gender transition treatment, addiction, and more.

“This has got to be worrying for the FDA because it means that you’ve got some very powerful justices who are willing to take on FDA’s scientific judgments, not just with this drug, but for others,” said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University.

On the Merits

For the FDA, the Supreme Court’s determination “means stability for some period of time,” said Wendy Parmet, a law professor at Northeastern University.

But the outcome wasn’t a decision on the merits of the case. The Fifth Circuit ordered restrictions on mifepristone, including limiting its ability to be used after seven weeks of pregnancy and provided via mail.

The Supreme Court’s order halts restrictions on mifepristone until the legal dispute plays out there and at the high court, should the justices eventually take the case on the merits.

“What they’re saying is, we’re not going to take this drug off the market” at least until hearing the case on the merits, Parmet said.

Nevertheless, the FDA came under fire in Alito’s dissent, which criticized the agency’s handling of the whirlwind of legal activity surrounding its approval of mifepristone.

“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,” Alito said.

Liz Sepper, law professor at the University of Texas at Austin, said it’s “quite striking” for Alito to suggest the government wouldn’t comply with the Supreme Court’s outcome. She said it’s “hard to see” what facts bolster that position.

The justice also wrote off warnings that Danco Laboratories, the brand name manufacturer of mifepristone, couldn’t market the drug under the lower court outcomes because it would be mislabeled. Alito said that wouldn’t occur “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.”

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.

The FDA said in an email Friday evening that it didn’t have any comment on the Supreme Court’s order. But Xavier Becerra, secretary of the Health and Human Services Department, which oversees the FDA, called the decision “an important step in the right direction as we vigorously fight to defend the FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs.”

Danco, which is also a party in the case, called the decision “an important step in maintaining access to medication abortion during the litigation,” and emphasized its support of the FDA’s “repeated and careful review of the data and literature in approving the drug and modifying the conditions under which it is available.”

Alito also criticized the FDA for not appealing a decision by a district court judge in Washington state that blocked the agency from imposing additional restrictions on mifepristone beyond the requirements in the agency’s existing safety program, including that prescribers and pharmacies be certified to dispense the pill. He also said that the FDA “opposed” the request of several states to intervene.

Sepper, however, noted there’s nothing for the FDA to challenge in the Washington decision. “What exactly would they have been appealing?” she said.

Far From Over

Alliance Defending Freedom, the legal group leading the challenge to mifepristone’s approval, said Friday its fight against the FDA is not over.

“Our case seeking to put women’s health above politics continues on an expedited basis in the lower courts,” ADF Senior Counsel Erik Baptist said in a statement. “We look forward to a final outcome in this case that will hold the FDA accountable.”

As the FDA looks at the road ahead, Alito’s strong criticism against the agency should be cause for concern and a sign that “we’re not out of the woods yet,” Gostin said.

“I have very little doubt that this is going to end up being decided by the Supreme Court,” Gostin said. “For him to have that kind of confidence that he could somehow spot scientific or process errors when the FDA could not and the whole unanimous science community cannot, I think, makes me worried about how far some Supreme Court justices could go, not just with this case, but in the future.”

The pharmaceutical industry and analysts have already expressed fears on what a decision overturning mifepristone’s approval could mean for other drugs that the FDA has deemed safe and effective.

“Allowing the courts to second-guess a decision by the FDA to approve a medicine would create significant uncertainty and harm for manufacturers, patients and physicians,” said Pharmaceutical Research and Manufacturers of America Executive Vice President and General Counsel Jim Stansel in a statement.

On April 14, the PhRMA filed a brief in the case backing the FDA.

David S. Cohen, a professor at the Drexel University Thomas R. Kline School of Law, said he took “solace in the fact that Alito was by himself, and no other justice wanted to publicly agree with him.”