In a significant decision made last Friday, a Texas federal judge issued a 76-page ruling suspending the Food and Drug Administration’s (FDA) approval of mifepristone, an abortion-inducing drug that has been on the market for more than two decades. The ruling essentially stops the prescription, distribution, and sales of the pills nationwide.
Then, within hours of the Texas decision, a Washington state federal judge in a separate case issued a potentially conflicting 31-page ruling which blocks the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone.” The ruling specifically prevents the FDA from reducing any access to the pills in the more than a dozen states that initiated the lawsuit. The judge rejected a nationwide injunction and said the ruling applies to the plaintiffs that include Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, District of Columbia, Hawaii, Maine, Maryland, Minnesota, and Pennsylvania.
Mifepristone, formerly known as RU-486, blocks a necessary hormone for the pregnancy to advance and cuts off blood and nutrients to the unborn baby, slowly starving it to death over one to two days. Mifepristone is taken with misoprostol, which induces labor and causes severe cramping, contractions, and bleeding to expel the baby from the womb.
While the two decisions seem at odds, and certainly cast doubt about the drug’s future, the Texas ruling may carry the most weight for it focused on FDA approval rather than just availability restrictions, and suspended the drug’s approval to be on the market in the first place. The ruling did not go into immediate effect allowing time for the federal government to appeal the decision. The Department of Justice did indeed swiftly appeal the ruling to the Fifth Circuit Court of Appeals increasing the likelihood that the U.S. Supreme Court will ultimately decide the pill’s fate.
In the Texas case, Alliance for Hippocratic Medicine v. FDA, U.S. District Court Judge Matthew Kacsmaryk sided with pro-life medical groups who asserted the initial FDA approval of the pills was improperly conducted, and that FDA regulatory decisions allowing them to be prescribed via telemedicine, sent by mail and dispensed at retail pharmacies were unlawful.
Judge Kacsmaryk wrote, “The Court does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion — which was the ‘whole idea of mifepristone.’”
He also stated bluntly that the casting aside of these safety restrictions resulted in many deaths and life-threatening adverse reactions to the pills. Whether the agency bowed to political pressure or not, he countered arguments that it was inappropriate to allow a challenge to a medication that has been approved for decades and noted the FDA deliberately blocked challenges to the drug’s safety and efficacy.
“Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right? Simply put, FDA stonewalled judicial review — until now,” Judge Kacsmaryk wrote.
Chemical abortions currently account for more than half of all abortions in the U.S., according to the pro-abortion Guttmacher Institute. Mifepristone, which the FDA approved for use in the first 10 weeks of pregnancy, recently became the most common method of abortion over a procedural option in the U.S. due to being a method of circumventing state laws banning procedural abortion in the wake of the Supreme Court overturning Roe v. Wade last year.
Liberty Counsel Founder and Chairman Mat Staver said, “The Texas decision blocking the questionable FDA approval of mifepristone represents a major victory for the sanctity of life and for the health and safety of women and girls. Chemical abortions harm women physically and emotionally and cruelly kill defenseless children in the womb. The FDA should be held accountable for its unlawful actions.”
