[This is part one of a series on the first-of-its-kind federal lawsuit,
Americans for Hippocratic Medicine v. U.S. Food and Drug Administration
, in which doctors and medical practitioners are asking the courts to
hold the FDA accountable
for its reckless and illegal approval of dangerous chemical abortion drugs.]
The
Food and Drug Administration
has one responsibility: to keep Americans safe from harmful products. In 2000, however, the FDA failed to protect America’s women and girls. Under political pressure from the outgoing Clinton administration, the FDA illegally approved harmful chemical abortion drugs without requiring or relying on any relevant studies.
Under Presidents Barack Obama and Joe Biden, the FDA ignored citizen petitions, stonewalled doctors’ concerns, and eliminated even the few safeguards it had on these drugs. Now, medical practitioners have finally gotten past the FDA’s bureaucratic delays and are able to go to court to stand up for their female patients who have been harmed by the agency’s haphazard approval. In a first-of-its-kind lawsuit, four medical groups and four doctors represented by Alliance Defending Freedom have filed
suit
asking the courts to strike down the FDA’s actions as illegal and irresponsible.
The FDA exploited its accelerated review authority to get chemical abortion drugs to market. To claim this authority, the agency labeled pregnancy an “illness” and said these drugs provide a “meaningful therapeutic benefit.”
But the FDA also sidestepped the required testing; it never actually looked at the harms and risks associated with these drugs in their labeled use. For example, the FDA looked at a study that required women to have an ultrasound to determine gestational age before having a chemical
abortion
— a sensible precaution because the risks skyrocket as pregnancy advances. But when the FDA approved chemical abortion drugs for use, the agency itself never required an ultrasound to verify gestational age.
This is just one example of the careless, illegal shortcuts the FDA used to approve these drugs. For more than two decades, women and girls have suffered because of them. They have experienced severe side effects ranging from intense pain and frightening bleeding to hemorrhaging requiring blood transfusions, life-threatening uterine infections, the potential loss of future fertility, and even emergency hysterectomies.
And all the while, the FDA has continued to strip away safeguards. In 2016, for example, the agency increased the gestational age cutoff from seven weeks to 10 weeks, even though the risk of complications increases as pregnancy progresses. At the same time, it removed requirements for abortionists to report non-fatal adverse events so that it would be difficult for anyone to ever learn about when women are harmed by these drugs.
As of 2021, the FDA no longer requires in-person prescribing or dispensing, or an in-person checkup, to determine ectopic pregnancies or gestational age. In 2000, the FDA required three in-person appointments to receive a chemical abortion. Now, abortionists do not need any in-person interaction with a woman to prescribe chemical abortion drugs, and the drugs are often even sent through the mail (in violation of existing federal law).
This opens the door to truly nightmarish scenarios. In one case, a woman thought she was around six weeks gestation. An abortionist prescribed chemical abortion medication without verifying this, even though it is not at all uncommon to be mistaken about gestational age (26% of supposed due dates are corrected as pregnancy progresses). The woman took the drugs, and while at home, by herself, she delivered a baby later determined to be between 30 and 36 weeks. The woman suffered lacerations and bleeding in addition to intense emotional trauma from labor and delivery without medical help — not to mention the harm of killing a nearly fully developed baby.
This is not the only case in which a woman has suffered serious emotional and mental harm from being uninformed about what a chemical abortion actually is. Women report being devastated when they see that the contents of their womb include a tiny person with discernable arms and legs and even fingers and noses.
The doctors in the lawsuit share horrific stories of what chemical abortion drugs do to women. Each of these doctors has treated many women who come into the emergency room bleeding, disoriented, or even unconscious, suffering from infections and on the verge of sepsis, or in terrible pain, passing blood clots the size of lemons.
Many of these women are shocked by these drugs’ effects. One physician, Dr. Tyler Johnson, says in his
declaration
in the lawsuit, “Many of the patients I have treated for complications with chemical abortion experience trauma […] and they are not adequately prepared to understand what the drugs will do to them. In these situations, it is clear to me that these women and girls could not have given informed consent to chemical abortion.”
The FDA has harmed women and girls with its reckless actions for far too long. The agency needs to be held accountable for allowing chemical abortion drugs to harm American women and girls — and for deceiving people into thinking these drugs are “safe.” Through this lawsuit, medical professionals are taking a stand and giving a voice to all those who have been silenced and ignored by the FDA and the abortion industry.
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Julie Marie Blake is senior counsel for regulatory litigation with
Alliance Defending Freedom
(
@ADFLegal
).
