‘Significant Victory’: Federal Judge Requires FDA Reverse Approval Of Abortion Pill

(Photo by OLIVIER DOULIERY/AFP via Getty Images)

Sarah Wilder Social Issues Reporter
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A federal judge ruled Friday that the Food and Drug Administration (FDA) must reverse its previous approval of the chemical abortion drugs mifepristone and misoprostol.

The Alliance Defending Freedom, representing the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Associations, as well as several doctors, brought a lawsuit against the FDA in November. They alleged that the agency “eliminated necessary safeguards” in their haste to approve the drug.

U.S. District Court Judge Matthew Kacsmaryk of Texas, a Donald Trump appointee, issued a preliminary injunction which will go into effect in seven days.

“Plaintiffs have credibly alleged past and future harm resulting from the removal of restrictions for chemical abortion drugs,” Kacsmaryk wrote in his opinion. (RELATED: California State Sen. Scott Wiener Calls Christian Org A ‘Hate Group’ For Saying ‘Men Cannot Have A Menstrual Cycle’)

The opinion also criticized the FDA for doing away with restrictions on the use of abortion pills in 2000.

“In September 2000, FDA abandoned its safety proposals and acquiesced to the objections of the Population Council and Danco,” the judge wrote. “Despite its ‘serious reservations’ about mifepristone’s safety, FDA approved a regimen that relied on a self-certification that a prescribing physician has the ability to diagnose ectopic pregnancies.”

If the case is appealed, it would go to the conservative-leaning Fifth Circuit Court of Appeals, and if appealed further could go to the Supreme Court.

The FDA had to designate pregnancy as an “illness” and abortion drugs as providing a “meaningful therapeutic benefit” in order to get the abortion drugs approved, according to the lawsuit.

“By illegally approving dangerous chemical abortion drugs, the FDA put women and girls in harm’s way, and it’s high time the agency is held accountable for its reckless actions,” the Alliance Defending Freedom said in a statement provided to the Daily Caller on Friday. “Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they can pose serious and life-threatening complications to the mother, in addition to ending a baby’s life.”

“The FDA never had the authority to approve these hazardous drugs and remove important safeguards. This is a significant victory for the doctors and medical associations we represent and more importantly, the health and safety of women and girls.”

Demand for abortion pills in states with the most abortion restrictions skyrocketed in the months following the Supreme Court’s reversal of Roe v. Wade, according to a study from The Journal of the American Medical Association (JAMA) Network.

The FDA announced in January that pharmacies would be allowed to dispense abortion pills to customers, but Walgreens has since decided it will not dispense the drug in many states, including some where the pills are legal.

New polling provided to the Daily Caller by CRC Research for Susan B. Anthony Pro-Life America found that 61% of Americans disagree that it is safe to distribute abortion pills through the mail with little to no supervision, including 41% that feel strongly about the statement. Based on what they know about the FDA, 51% of Americans disagree that the abortion pill has been vetted carefully enough to protect women’s health and safety, compared to 39% who agree it has been vetted sufficiently. 

Twelve blue states filed a lawsuit against the FDA in February for placing “burdensome restrictions” on mifepristone, arguing that limits on “who can prescribe and dispense the drug” violate the Due Process Clause of the Fifth Amendment.