U.S. Judge Matthew Kacsmaryk for the Northern District of Texas, a Trump appointee, will hold a hearing on a case concerning FDA approval of chemical abortion drugs in this country that could result in forcing these dangerous drugs off the market.
According to a press release from Alliance Defending Freedom (ADF), a nonprofit legal organization, 67 members of Congress, along with numerous pro-life organizations and 23 states are supporting four national medical associations and four doctors experienced in caring for pregnant and post-abortive women are suing the federal government for illegally approving chemical abortion drugs that harm women and girls.
The case, known as Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, bases its argument on the fact that in the year 2000, the U.S. Food and Drug Administration gained speedy approval of the chemical abortion drugs mifepristone and misoprostol by characterizing pregnancy as an “illness” and arguing that these drugs provide a “meaningful therapeutic benefit.”
The FDA never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen.
Thus, by approving chemical abortion drugs, the doctors and medical groups assert that the FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.
“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,” said ADF Senior Counsel Erik Baptist, who is representing the Alliance for Hippocratic Medicine. “We and the many parties who are supporting the national medical associations and doctors hope the court will agree the FDA never had the authority to approve these dangerous drugs and reject the marketing and distribution of them.”
In their reply brief, ADF attorneys note that “after stonewalling [the medical groups and doctors] for nearly two decades, the FDA admitted what [the medical groups and doctors] have been saying all along: the agency has never required or relied on a single study that evaluated the safety and effectiveness of these drugs under real-world conditions. Without these vital studies, the harms that these drugs inflict on women are a heartbreaking, yet unsurprising, reality.”
To make matters worse, in 2016, the FDA extended the permissible gestational age of the baby for which a girl or woman may take chemical abortion drugs—from seven weeks’ gestation to 10 weeks’ gestation—increasing the mother’s risk of adverse complications.
The FDA also changed the dosage and route of administration for the drugs, reduced the number of required in-person doctor visits from three to one, expanded who could prescribe and administer chemical abortion drugs beyond medical doctors, and eliminated the requirement for abortionists to report non-fatal complications from chemical abortion drugs.
Further, in 2021, the FDA announced that it would allow abortionists to send chemical abortion drugs through the mail—in direct violation of longstanding federal law. As the lawsuit points out, this decision puts girls and women at additional risk from chemical abortion drugs since mail-order, at-home abortions skip necessary medical examinations to ensure that girls and women do not have conditions that could lead to fatal outcomes.
“The FDA’s new regulations now allow women to self-manage their chemical abortions without ever seeing a doctor in person,” the Charlotte Lozier Institute said in its brief. “Yet the consequences of telemedicine chemical abortion are almost too numerous to count—lack of necessary ultrasounds to confirm gestational age and rule out ectopic pregnancy, inability to confirm that a woman is not being coerced to obtain an abortion, abandonment of women to deal with the medical and psychological repercussions of abortion by herself with no follow-up, and grave harm to physicians who are expected to clean up the mess (in the ER and elsewhere) of self-managed abortion.”
As the brief filed by 22 states explains, “The serious nature of the FDA’s unlawful actions, and the agency’s decision to invite lawbreaking by private parties and government actors across the country, favors broad relief. The FDA and the Administration as a whole have no intention to respect the Constitution, the Supreme Court, or the democratic process when it comes to abortion. This Court’s decisive action is warranted.”
A judgement against the FDA could result in withdrawing these drugs from the marketplace, which would include states where abortion is legal. Because mifepristone, the first of the two drugs used in chemical abortions, accounts for 53 percent of all abortions in the country, a ruling against the FDA would result in a dramatic decrease in the number of abortions in the U.S.
The case is so consequential that Judge Kacsmaryk asked attorneys not to announce the March 15 hearing date to the public until today to avoid any disruption of the proceedings. Kacsmaryk and his staff have reportedly faced “security issues, including death threats” because of this case.
Please take a moment today to pray for the judge and attorneys involved in this case that they may be successful in protecting the lives of women and their unborn babies by ridding the market of these dangerous drugs.
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