by In a follow-up lawsuit seeking to overturn the Food and Drug Administration’s approval of abortion pills, Democratic and Republican attorneys general took sides in court filings Friday.
The lawsuit was filed in November by an anti-abortion group called the Alliance for Hippocratic Medicine. They allege that the process the FDA used decades ago to review and approve drugs used for medical abortions (mifepristone and misoprostol) was illegal and should be repealed.
The plaintiffs sought a court order requesting that the FDA’s approval of mifepristone be revoked while the case unfolds.
This week, the manufacturer of mifepristone, Danco Laboratories, intervened legally in the case, joining the defense.
The District Court judge overseeing the trial, Matthew J. Kacsmaryk in the Northern District of Texas, was appointed by President Trump. His decision is expected to come sometime after February 24. If it rules in favor of the Alliance for Hippocratic Medicine, access to medical abortion could be called into question.
Medical abortion accounts for more than half of all abortions nationwide, according to the Guttmacher Institute, a research group that supports abortion rights.
There is little legal precedent for a court to revoke FDA approval of a drug. But if that were to happen, the Biden administration would likely appeal such a decision to the generally conservative Fifth Circuit Court in New Orleans. The case could eventually end up in the Supreme Court.
On Friday, New York Attorney General Letitia James led a coalition of 22 attorneys general in filing a report arguing that if the FDA were ordered to rescind its approval of mifepristone, it would have «devastating consequences» for women. in the US, regardless of origin. her state’s abortion policy.
Meanwhile, Mississippi Attorney General Lynn Fitch led a group of 22 Republican attorneys general who filed a report calling the FDA’s approval of abortion pills «deeply flawed.»
Representing the plaintiffs are lawyers from the conservative Christian legal defense group Alliance Defending Freedom, which also played a leading role in Dobbs v. Jackson Women’s Health Organization that led to the quashing of Roe v. Wade.
Mifepristone has had FDA approval since 2000 for use in combination with misoprostol to terminate pregnancies up to 10 weeks. Misoprostol, for its part, was the first approved in 1988 for a different purpose: the prevention of gastric ulcers.
Used together in consultation with a physician, the two-drug regimen successfully ends a pregnancy in about 99.6% of the timeand has a 0.4% risk of major complicationsaccording to the National Library of Medicine.
In court filings last month, the FDA said its approval of mifepristone came after a thorough review of the scientific evidence. The agency called the lawsuit «extraordinary and unprecedented,» adding that the plaintiffs asked the court to reverse «a long-standing scientific determination based on speculative allegations of harm offered in support of claims and arguments that are untimely, inexhaustible.» and without merit.»
In their supporting brief Friday, the Democratic attorneys general argued that reversing the approval of mifepristone would restrict access to abortion nationwide and force patients to undergo surgical abortions, which are more invasive and often more expensive, or to forgo an abortion altogether. The group also argued that it would undermine «the integrity of the FDA’s approval process.»
«Blocking access to this safe and effective medicine is a dangerous attack on reproductive freedom and public health,» James said in a statement. “Decades of medical and clinical research have shown that medical abortion is safe. Despite these facts and their widespread use, we know this is not a debate about science.»
Meanwhile, the Republican attorneys general argued that the FDA «has acted to establish a national abortion-on-demand regime by granting widespread access licenses to chemical abortifacient drugs, in defiance of federal and state laws.»
Fitch added in a statement: “In the Dobbs case, the Supreme Court affirmed that states can enact laws that protect unborn life, women’s health, and the integrity of the medical profession, and we will not allow the Biden administration to trample this fundamental constitutional building block.
In the wake of the Dobbs decision, the FDA has taken several steps to protect and expand access to abortion medications. Last month, the agency finalized a rule change that allows retail pharmacies to dispense mifepristone. Both CVS and Walgreens have said they plan to dispense the pill in states where abortion is legal.
