The U.S. Food and Drug Administration approved mifepristone, a key abortion drug, 23 years ago, and experts say it has been found to be safe, a claim a group of anti-abortion groups and four doctors challenge in seeking revocation of its federal approval. | Getty Images
America’s major medical institutions and drug policy scholars have roundly denounced as “pseudoscience” many of the claims brought by anti-abortion groups in a high-profile federal lawsuit asking the Food and Drug Administration to revoke its 23-year-old approval of mifepristone, one half of a two-drug regimen that has become the most common form of pregnancy termination post-Roe v. Wade.
But the appeals court’s three-judge panel that heard oral arguments Wednesday appeared to be persuaded not by the medical consensus in this case, but by some of the evidence brought forward by plaintiffs that consists largely of anecdotes, speculation, and cherry-picked studies brought by a handful of anti-abortion medical groups and doctors.
Medical and public health societies led by the American Medical Association submitted a “friend of the court” brief before the 5th U.S. Circuit Court of Appeals, stating that the lower court’s ruling “relies on pseudoscience and on speculation, and adopts wholesale and without appropriate judicial inquiry the assertions of a small group of declarants who are ideologically opposed to abortion care and at odds with the overwhelming majority of the medical community and the FDA.”
While asking a question of U.S. Deputy Assistant Attorney General Sarah Harrington, Judge Jennifer Walker Elrod referred to mifepristone cutting off “nutrition” to the fetus, which is a false claim cited in the initial ruling written by Texas federal Judge Matthew Kacsmaryk in April. Kacsmaryk referred to mifepristone as a “synthetic steroid that blocks the hormone progesterone, halts nutrition, and ultimately starves the unborn human until death.”
According to Johns Hopkins Medicine, the progesterone hormone is produced in early pregnancy to help thicken the lining of the uterus to support implantation of a fertilized egg. Without that hormone stimulation, which mifepristone blocks, the lining breaks down and the pregnancy cannot continue. It is then followed by doses of misoprostol to induce contractions and expel the pregnancy.
Former President George W. Bush appointee Elrod – like her fellow Donald Trump appointee Judges James C. Ho and Cory T. Wilson – shares ideological views on abortion with the plaintiffs’ anti-abortion coalition, which is represented by the Alliance Defending Freedom. So does Kacsmaryk, whose since-blocked decision to suspend FDA approval of mifepristone cites anecdotal evidence from plaintiffs.
Mifepristone remains legal and on the market as the case winds its way through the legal system, and data from the FDA since the drug’s initial approval in 2000 shows it is overwhelmingly safe to use. Out of an estimated 5.6 million people in 23 years, 28 deaths have been associated with the FDA’s abortion medication regimen, which is a markedly lower rate than many common FDA-approved drugs, like Tylenol and Viagra. And as the FDA has noted, that number includes fatal cases “regardless of causal attribution to mifepristone,” such as people who died from homicide, suicide, and pulmonary emphysema.
If the plaintiffs prevail, health care providers, medical institutions and pharmaceutical industry organizations have warned of its potentially catastrophic consequences. In addition to radically reducing access to abortion nationwide, removing mifepristone from the market would reduce access for miscarriage treatment, public health experts say, and have far-reaching consequences beyond abortion.
“The implications of this case are extraordinary, and they include the potential termination of access to mifepristone, a precedent for court interference in the FDA’s rigorous and science-based testing and approval process not just for mifepristone, but for any drug,” said Joanne Rosen, a senior lecturer in the departments of Health Policy and Management and Population, Family and Reproductive Health at the Johns Hopkins Bloomberg School of Public Health, during a media briefing hosted by the university Thursday. “This would be the first time in history that a court has abrogated the FDA’s approval of a drug over the objections of the FDA.”
Sympathetic, cynical and combative exchanges
The appeals court judges seemed sympathetic to the narrative brought by the plaintiffs that mifepristone is a dangerous drug, as they were in their previous opinion blocked by the Supreme Court, which would have restricted the use of mifepristone. A big question in this case has been whether the coalition of anti-abortion medical groups and four doctors, including Indiana state Sen. Dr. Tyler Johnson, have standing to sue. Plaintiffs have argued their doctors would suffer direct harm if mifepristone remains on the market.
Like medical and legal scholars following this case, Rosen said plaintiffs’ arguments for standing are weak, and if accepted would open the door to any group that wants to challenge the FDA’s approval of a drug for any reason.
Plaintiff groups argue that their member doctors could be overwhelmed with a potential future influx of emergency room visits from mifepristone patients, or forced to treat an abortion patient against their will. These claims are based not on robust data but largely on the testimony of handful of plaintiff doctors, three of whom give mostly non-specific anecdotes about treatment they performed for women who allegedly had taken some form of medication abortion, but it’s not clear when the procedures took place and whether it was the FDA’s regimen.
Harrington argued on behalf of the federal government that plaintiffs had not made claims of being forced to treat abortion patients against their will.
“They claim injury from speculative downstream effects of choices made by a chain of other people who are not parties to this lawsuit,” Harrington said.
But Wilson pushed back.
“The declarants here said they’ve seen these patients, they’ve cared for them,” he said. “I take that to mean that they treated them and that they expect to see more in the future. How’s that not enough for standing if the doctor also has a conscience objection to doing so?”
The judges made a series of sometimes snarky and combative comments and questions aimed at the attorneys for the U.S. Department of Justice, representing the FDA, and the mifepristone manufacturer Danco Laboratories, and called into question trust in the FDA’s expertise and judgment.
Echoing plaintiffs’ criticism of the FDA approving mifepristone as part of a particular category of drugs for serious illnesses, Ho said pregnancy is not a serious illness, quipping, “When we celebrated Mother’s Day, were we celebrating illness?”
A question of evidence
And they misstated non-scientific assertions by plaintiffs, such as claiming that non-fatal adverse reporting is no longer required by the FDA. Mifepristone manufacturers (but no longer medical providers) are still required to report non-fatal adverse reactions.
Much of the anti-abortion evidence submitted in this case was authored by researchers who work for the anti-abortion Charlotte Lozier Institute, whose role is to defend abortion bans and restrictions with research. Regarding mifepristone, Charlotte Lozier’s researchers have published articles that mostly speculate large amounts of under-reporting when it comes to abortion complications, and argue the true risk of mifepristone is unknown.
Another anti-abortion organization, the Family Research Council, also submitted a 125-page amicus brief with false claims that the drug approval was expedited by former President Bill Clinton. It also cites research from the Charlotte Lozier Institute to back claims that the drug is unsafe.
Judges echoed this sentiment and speculated on the safety of telemedicine abortion and questioned the FDA’s process of loosening restrictions over time. Elrod asked Harrington if a medical provider could examine someone via email rather than video, and if people could use telemedicine as an “intermediary” to send the medication to a state with an abortion ban. Elrod referenced amicus briefs that alleged individuals were engaging in those tactics to skirt state laws.
Harrington said the statements referenced by Elrod in the briefs are unsupported and irrelevant to the central issue.
“None of that is dictated by the FDA, and none of that is relevant to whether the FDA’s determination that this drug is safe and effective with these conditions in place,” Harrington said.
Elrod pushed back, asking if it was a relevant factor to consider in issuing an injunction that would limit access to the drug.
“If it’s violating other law, which we have to determine, perhaps, then we have to decide whether or not it’s appropriate to enter an injunction or not and that’s one of the factors we would consider,” Elrod said.
Public health experts say the appeals court’s attitudes toward the science in this case are deeply concerning.
“Judges and lawmakers should not be substituting their own opinion for the experience, expertise, and authority of the U.S. Food and Drug Administration. Nor should they ignore the substantial weight of scientific evidence from hundreds of studies and millions of patients confirming the safety and effectiveness of mifepristone, which has been used for decades in both medication abortion and miscarriage management,” said AMA President Dr. Jack Resneck Jr. in a recent statement.
Even if the appeals court rules to restrict or revoke approval of mifepristone, the federal government will most likely appeal the case to the U.S. Supreme Court. Regardless, the 5th Circuit Court judges’ reasoning could prove influential to the Supreme Court’s eventual decision.
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