National News

Federal Judge Hears Arguments Challenging FDA’s Approval of Abortion Pill

An illustration shows a paper bag containing the mifepristone and misoprostol pills used for a chemical abortion, follow-up instructions and small warming packs. (Photo: OSV News)

WASHINGTON — A federal judge in Texas heard arguments on March 15 challenging the Food and Drug Administration’s approval of mifepristone, one of two drugs used in chemical abortions. 

The case before U.S. District Judge Matthew Kacsmaryk aims to block access to the pill approved by the FDA in 2000, saying the agency incorrectly determined the drug’s safety and effectiveness and went beyond its regulatory authority in approving it. 

Reports on the hearing by The Associated Press indicate the judge seemed willing to side with the plaintiffs’ attorneys, asking them how he might draft a preliminary injunction of the abortion drug and even saying at one point that the outline of their arguments “tracks the elements for an injunction nicely.”

Lawyers representing the FDA argued that banning mifepristone would have a drastic impact.

“An injunction here would interfere with the interests of every state in the country,” said Julie Straus Harris of the U.S. Justice Department, representing the FDA.

AP reported that Kacsmaryk asked the plaintiffs’ attorneys about the possibility of suspending mifepristone’s approval without withdrawing it completely.

“Any relief you grant must be complete” and apply nationwide, said Erik Baptist, senior counsel of Alliance Defending Freedom, representing the plaintiffs. “The harms of these abortion drugs know no bounds,” he added.

The suit was filed by the group Alliance for Hippocratic Medicine on behalf of itself and member groups such as the Catholic Medical Association, the Christian Medical and Dental Associations, and others that are pro-life. 

The plaintiffs were represented by Alliance Defending Freedom, a religious liberty law firm. The judge allotted four hours for the hearing and did not announce the date until two days before, hoping to lessen protests. 

Pro-life groups, several members of Congress, and state attorneys general filed friend-of-the-court briefs siding with the plaintiff. 

The hearing examined the suit’s claims that the FDA “ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls” and disregarded evidence that chemical abortions cause more complications than surgical abortions. 

The lawsuit, filed in November, also took issue with the FDA’s recent elimination of safeguards for mifepristone’s use by allowing the drug to be provided through the mail, which it claims violates federal law. Earlier this year, the FDA also approved the sale of mifepristone through pharmacies that receive FDA certification. 

If the judge suspends the FDA approval of mifepristone, abortion clinics have said they will either only use misoprostol, the other drug used in medical abortions, or would only provide surgical abortions. 

Kacsmaryk’s decision will likely be appealed to the U.S. Court of Appeals for the 5th Circuit and could eventually go to the Supreme Court. 

If he sides with the plaintiffs, it would be the first time a court has ordered the government to withdraw or suspend approval of a medication despite opposition from the FDA and the drug’s manufacturer. 

Mifepristone, also known as RU-486, is the first of a two-drug regimen used to end a pregnancy in its early stages — through 10 weeks gestation. It is often described as a medication abortion pill.

According to the Guttmacher Institute, which conducts research on abortion and reproductive health, medication abortion accounted for 54% of all abortions in the U.S. in 2022. 

A brief filed by the American Medical Association and other medical groups said if the court reverses mifepristone’s FDA approval, it would cause “profound and irreparable harm to patients across the country.”

It also said the plaintiffs took a position “that is fundamentally ideological, not scientific.” 

Baptist said in a statement that the “FDA’s approval of chemical abortion drugs has always stood on shaky legal and moral ground, and after years of evading responsibility, it’s time for the government to do what it’s legally required to do: protect the health and safety of vulnerable women and girls.”