When the Supreme Court hears arguments on Tuesday about the availability of a widely used abortion pill, the discussion is likely to focus on rules around prescribing the drug by telemedicine and sending it by mail.
Those changes, which broadened access to the pill starting in 2016, are at the center of the debate because an appeals court narrowed the scope of the case.
The appeals court imposed some limits on a sweeping ruling from a judge in Texas that had suspended approval of the pill because it had found that the statute of limitations — the deadline for filing lawsuits — for certain aspects of the drug had lapsed.
The Food and Drug Administration first approved the pill, mifepristone, in 2000, long before the current lawsuit was filed in November 2022.
The F.D.A.’s regulations require groups objecting to its actions to file a petition with the agency. If that petition is denied, the challengers then have six years to sue.
Two of the groups in the current suit filed the required petition in 2000, and the F.D.A. failed to act on it for 16 years before finally denying it in March 2016. That gave the plaintiffs until March 2022 to sue over the initial approval. They missed that deadline by more than six months.
Judge Matthew J. Kacsmaryk of the Federal District Court in Amarillo, Texas, nevertheless allowed the challenge to proceed, saying that later actions by the agency had “reopened” the deadline and restarted the six-year clock. He added that, in any event, the deadline should be waived under the doctrine of “equitable tolling.” Under the doctrine, tardy suits are sometimes allowed in the name of fairness when, as the Supreme Court has put it, the plaintiff encountered “extraordinary circumstances that stood in the way of timely filing.”
Judge Kacsmaryk said the F.D.A.’s “unreasonable delay” in responding to the petition and “the public interest in this case” were sufficiently extraordinary to warrant equitable tolling.
A divided three-judge panel of the United States Court of Appeals for the Fifth Circuit endorsed much of Judge Kacsmaryk’s reasoning. But it drew the line, tentatively, at allowing the untimely challenge to the 2000 approval.
“Although a close call, we are unsure at this preliminary juncture and after truncated review that F.D.A. reopened the 2000 approval,” the majority wrote, adding that “no ‘extraordinary circumstance’ prevented plaintiffs from filing within six years of F.D.A.’s 2016 petition denial.”
But the panel concluded that “the lion’s share of the challenged actions are squarely within the six-year window,” referring to actions by the agency that increased access to the pill starting in 2016. The appeals court’s ruling effectively reinstated requirements for in-person visits with doctors, rolled back the availability of mifepristone from the first 10 weeks of pregnancy to seven weeks and barred dispensing it by mail.
