Restoring Safety Protocols and Accountability at FDA


Demonstrating the old maxim that sunlight is the best disinfectant, the case of AHM v. FDA is bringing to light twin threats to the health of America’s body politic – unaccountable federal agencies and disrespect for the rule of law.

Over two decades ago, the FDA abandoned its mission of protecting the health and safety of Americans in favor of pushing a political agenda. The results of the FDA’s lawlessness have compounded the tragedy of the loss of life by chemical abortion with serious harm to the women and girls taking these drugs. Now, members of Congress from both parties, Nancy Mace (R) and Alexandria Ocasio-Cortez (D), are compounding the executive branch agency’s flagrant disdain for the rule of law by adding their encouragement for the FDA to ignore any adverse ruling by the courts.

During congressional hearings on the COVID-19 pandemic and the approval of the vaccine, Representative Mace was notably skeptical of the bureaucratic experts. Yet when it comes to the dangers of chemical abortion drugs, she is not merely deferential to the FDA but encouraging its unelected executive branch employees to thumb their noses at a co-equal branch of government. Our elected legislature should embrace its constitutional role as a check and balance on the executive branch instead of abdicating the responsibility to the judicial branch, or worse, undermining the rule of law.

In 2000, the FDA approved chemical abortion drugs for use in the United States. The only way the FDA could have approved these chemical abortion drugs was to characterize pregnancy as an “illness” and argue that these deadly drugs provide a “meaningful therapeutic benefit.” In approving these chemical abortion drugs, the FDA needed to disavow science because the FDA never studied the safety of the actual drug regimen, ignored the potential impacts of the hormone-blocking chemical on the developing bodies of adolescent girls, and disregarded the undisputed evidence that chemical abortions cause more complications than even surgical abortions.

Since then, the FDA has not reversed course, followed the science, or fixed its mistakes to protect women and girls—instead, after stonewalling the doctors’ citizen petition for fourteen years, it removed the few safeguards that were in place. In 2022, ADF attorneys—representing medical associations and individual doctors who treat women harmed by chemical abortion—filed a lawsuit challenging the FDA’s approval of chemical abortion drugs and subsequent evisceration of the few safeguards for this drug regimen. These doctors and associations have followed the science and the law in stark contrast to the FDA.

U.S. District Court Judge Matthew Kacsmaryk granted a preliminary injunction to these doctors, which indicates the court determined the plaintiffs are likely to succeed on the merits of the case. The FDA then filed an emergency appeal to the U.S. Court of Appeals for the Fifth Circuit. The 5th Circuit upheld most of the injunction and prohibited abortionists from sending chemical abortion drugs through the mail, which the FDA had been allowing since 2021, in direct violation of longstanding federal law.

Additionally, 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. The 5th Circuit restored the seven-week gestation limitation, protecting the mother from adverse complications that increase with gestational age, reinstated necessary doctor visits, and brought back the requirement that abortionists must check women for complications after their chemical abortions.

The 5th Circuit also agreed with ADF attorneys that the FDA’s approval of generic mifepristone was unlawful. Currently, the case is on another emergency appeal to the United States Supreme Court.

We hope the Supreme Court will reject the FDA’s unlawful actions that harm women and innocent children in the womb, resulting in the removal of a dangerous drug that never should have been approved. Or at the least, necessary safety protocols will be restored to reduce the significant risk posed by the drug regimen to women and girls in our country. Secondarily, yet still vitally important to our republic, would be a clear reminder to the FDA that they are and will remain accountable to the citizens of this nation, even if some in Congress say otherwise.

Lathan Watts is vice president for public affairs at Alliance Defending Freedom.

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