The US Supreme Court questioned the legality of the challenge

The future of the FDA: the “Daughter of Dobbs” and the case of the U.S. Supreme Court of Human Rights

Justice Jackson said he was concerned that there was a significant mismatch in the case of the injury and the remedy being sought. “The obvious common-sense remedy would be to provide them with an exemption, that they don’t have to participate in this procedure,” she added. Existing federal and state laws already allow health care providers to refuse to perform abortion-related care, noted solicitor general Elizabeth Prelogar, who was representing the US government at the hearing.

Only this time, there is more at stake than abortion rights. The FDA has been seen as the gold standard for safety and innovation because of it’s regulatory power to approve drugs and continually evaluate them.

More than half of American women who choose to terminate a pregnancy do so using a two-drug combination of pills. This case is referred to as “daughter of Dobbs.” The Supreme Court left the legality of abortion to the states in a decision in early 2022, reversing an earlier ruling.

“It would be traumatizing to the system,” says Marsha Henderson, a former FDA associate commissioner for women’s health and a 22-year veteran of the agency.

“We have a clear scientific approach and it’s not just a helter-skelter set of ad hoc opinions,” Henderson says. “There are teams of scientists and researchers that participate over many years, starting from phase one pre-clinical all the way through post market…and the information, the data evolve, and they collectively help to enhance the whole research world.”

The FDA’s initial approval of the pill, which occurred nearly 25 years ago, is no longer subject to challenge. Instead, at issue are many of the conditions which were imposed on the drug when it was first approved, conditions that have since been lifted.

In this case, there are almost all of the major medical associations in the country siding with the FDA. On the other side is the Alliance for Hippocratic Medicine, which contends that the FDA’s loosening of restrictions is unjustified and unsafe.

“Regardless of one’s views on abortion,” she says, “we should want women to take those drugs with sufficient safeguards, as well as want the FDA to do its job.” It didn’t do that, she contends.

Later that year, the US Court of Appeals for the Fifth Circuit ruled that mifepristone should remain an approved drug but invalidated the FDA’s recent actions to make it more accessible. The Fifth Circuit decision didn’t take effect immediately because the Supreme Court stayed Kacsmaryk’s ruling.

In the year 2016 the FDA granted permission to use Mifepristone for up to 10 weeks of pregnant women, and it also reduced the required number of in-person doctor’s appointments from three to one.

The in-person requirement was temporarily removed by the FDA at the peak of the Pandemic. Patients were able to get their prescriptions filled at the pharmacy or by mail instead of going to a clinician’s office.

Eight months later, the agency looked at data collected during the “natural experiment” created by the pandemic. It found no difference in serious adverse events whether the drug was dispensed in person or not.

The data used by the FDA to justify the changes it made to the way that abortion is performed is insufficient, according to the lawyer for the anti-abortion doctors association.

The Supreme Court’s decision to rule out mifepristone’s safety is outrageous: Do pro-life doctors have standing?

“For that reason, the records show that there is a twofold increase in the risk of ectopic pregnancies, from 7 to 10 weeks,” he says.

“The number of women who need any follow-up care…went from roughly eight percent to somewhere between two and three percent,” Ellsworth says. “So they’re just wrong when they suggest that there is some kind of additional complications that were brought on by moving to 70 days.”

They do have standing according to Hawley. “The fact that our pro-life doctors have oriented their practices and even their lives to avoid elective abortion procedures, I think goes to show that those doctors do have standing here.”

No matter which side prevails, a single aspect of this case is truly remarkable. One would be hard pressed to find another case in which the government regulator, the regulated industry, and even the independent watchdog group that frequently criticizes the agency are all on the same side.

The justices seemed to think the case didn’t have standing, according to Eva Temkin, a lawyer specializing in FDA regulatory issues at the law firm Paul Hastings. The court didn’t focus much on the appropriateness of the FDA’s actions, she says. “I am very hopeful that the Supreme Court was not immersed in those issues as much because they recognized how outrageous it would be to find the FDA scientific judgment here was not exercised appropriately.”

In his decision, Kacsmaryk relied on problematic studies to question mifepristone’s safety. Two papers1,2 he cited were retracted in February because of problems with study design and methodology and errors in data analysis, among other issues. The prevailing scientific literature3,4 contradicts the papers that Kacsmaryk cited.

Drug development could potentially be affected by the decision. The Fifth Circuit called for a cumbersome and unprecedented new standard for drug approval. If the Supreme Court follows that lead, “that would create delays, that would create inefficiencies and costs and would ultimately undermine patient access to scientifically appropriate medicines,” Temkin says.