Judge Weighs FDA Approval of Abortion Drug


WASHINGTON — A federal district judge heard oral arguments Wednesday in a controversial case that could decide the fate of the Food and Drug Administration’s approval of the abortion drug mifepristone — a decision that would have broad ramifications nationwide.

The case, Alliance for Hippocratic Medicine v. FDA, could block access to mifepristone, which is used for abortions and for miscarriage management. Medication abortions, which involve taking mifepristone and a second drug, misoprostol, make up the majority of abortions in the United States.

The lawsuit was filed last year by the Alliance Defending Freedom against the FDA on behalf of three physician groups that belong to the Alliance for Hippocratic Medicine — the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians and the Christian Medical and Dental Associations — and four individual physicians.

ADF asked Judge Matthew Kacsmaryk, who heard oral arguments Wednesday before the U.S. District Court for the Northern District of Texas, to pull mifepristone from the market immediately, arguing that the FDA did not follow proper protocol in its 2000 approval. Kacsmaryk is a Trump appointee confirmed by the Senate in 2019.

ADF’s attorneys argued that since “pregnancy” is not a disease, mifepristone should not have been considered eligible to be evaluated under the FDA’s accelerated approval program and is unsafe, per an Associated Press report.

Mifepristone was first approved in France in the 1980s, before gaining FDA approval in the U.S. in 2000 following a four-year deliberation process.

Abortion opponents have pushed back on the drug and advocated for tighter regulations on the drug since its approval. The Government Accountability Office issued reports in 2008 and 2018  that found that the approval process was consistent with that of other similar restricted drugs.

It would be an unprecedented move for a court to rescind the FDA’s approval of a drug that has been available on the market for many years, and experts worry that a ruling to pull the drug from the market could have unintended consequences by setting a precedent to challenge the approval of other FDA-approved drugs.

“The court has never taken this kind of action that has been requested to remove a safe and effective drug from the market,” said Carrie Flaxman, senior director for public policy litigation and law for Planned Parenthood Federation of America, in a call with reporters Wednesday. “We are in unprecedented waters.”

A preliminary injunction would block the sale and dispensing of mifepristone, but multiple legal experts have said it is unclear what would happen to existing stock in doctors’ offices and other health facilities given the multiple possible outcomes.

ADF senior counsel Erik Baptist told Kacsmaryk that he could not name a prior example of a court overturning the FDA’s approval of a drug, but said the group has petitioned the agency to withdraw the drug’s approval starting in 2002.

Baptist, in a statement following arguments, said the FDA’s approval of mifepristone has “always stood on shaky legal and moral ground.”

“As we stated in court, the FDA never had the authority to approve these drugs and remove important safeguards, despite the substantial evidence of the harms women and girls who undergo this dangerous drug regimen could suffer,” he said.

The Justice Department and Danco Laboratories, one of the two U.S. drugmakers that manufacture mifepristone, argued in favor of the FDA, arguing the drug is effective and has limited side effects.

Kacsmaryk publicly announced the hearing on Monday and stated following arguments that he would announce a decision “as soon as possible.” If he issues a preliminary injunction, the Justice Department is expected to request an emergency stay from the 5th Circuit Court of Appeals.

Kacsmaryk recently came under fire for encouraging the legal teams involved with the case not to publicize details about the hearing to avoid having “any unnecessary circus-like atmosphere of what should be more of an appellate-style proceeding” according to a March 10 court transcript.

The unusual nature of the announcement spurred action from abortion rights advocacy groups — a mobile billboard in downtown Amarillo criticizing the judge from gender advocacy group UltraViolet and costumed “Kangaroo Court” and clown-themed local protests organized by the Women’s March.