A federal court recently heard arguments in a first-of-its-kind lawsuit that four medical associations and four doctors filed through their attorneys with Alliance Defending Freedom against the U.S. Food and Drug Administration.
The lawsuit asks the court to hold the FDA accountable for recklessly approving chemical abortion drugs that harm women and girls. It is a bold step toward safeguarding women’s health and safety against an industry – and a government agency – that has disregarded both for two decades.
When the FDA approved these drugs in 2000, it did so without studying whether they are safe according to their labeled use. Since then, the FDA has stripped away even the most basic safeguards on prescribing and using chemical abortion drugs despite the many incidents when they harmed women and girls.
Dr. Tyler Johnson is one of the doctors filing suit. He has treated many women in the emergency room who took chemical abortion drugs and had severe responses. In one incident, a woman received these drugs from a clinic and began bleeding heavily. By the time she arrived at the hospital, she was unconscious. Johnson gave her emergency treatment and a blood transfusion to save her life. The drugs were used according to the FDA-approved labeled use, and a woman almost died.
This is far from the only incident like this. One in five women who take chemical abortion drugs will seek medical attention. Women have even died from them. Johnson says that, in his emergency room alone, he’s seen multiple cases of heavy bleeding from chemical abortion drugs – so much bleeding that the women had to have surgery and blood transfusions.
The medical professionals represented in the lawsuit have treated many women who sought emergency medical help after using such drugs. But, because of the FDA’s minimal safeguards, none of these situations fell outside the agency’s parameters for drug usage.
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How did we get here? The FDA never studied the safety of chemical abortion drugs as they are actually used.
That last phrase is important. The FDA did look at studies about these drugs, but only studies that included safeguards it didn’t subsequently require or that used the drugs in a different way. The clinical trials on which the agency relied didn’t come from unbiased investigations, and these trials were not blinded, randomized or concurrently controlled. Nothing about the FDA approval process was up to the standards that apply to the approval of a new drug.
In the years since 2000, the FDA never conducted the missing studies – even as it has stripped away the few safeguards that originally were in place to protect women in girls.
In 2000, chemical abortion drugs could only be given up to seven weeks of pregnancy; in 2016, the FDA changed that to 10 weeks. In 2000, the drugs could only be dispensed under the supervision of a physician; in 2016, the FDA said that any health care provider could dispense them, such as a physician assistant or other unqualified non-doctor clinic staff.
Originally, abortionists were required to dispense and administer the drugs in person, so if anything went wrong, the dispensing doctor was at least close by. In 2000, the FDA required three in-person visits: one for receiving each drug and one follow-up appointment. In 2016, the FDA decided that administration of the drugs no longer had to be in person; women could take them at home (or at a hotel, or at school) without any medical supervision.
Also in 2016, the FDA excused the drug manufacturer from doing post-approval safety studies and then stopped requiring prescribers to report adverse effects from the drugs to the agency. That way, the FDA could remain willfully ignorant about the injuries its actions have inflicted on women. And this year, the FDA said that the drugs can be stocked by local pharmacies, thereby turning them into abortion sites.
The doctors who filed this lawsuit can testify to what can happen next. Chemical abortions have a complication rate four times higher than surgical abortions. Many women, after taking these drugs at home alone, go to the emergency room with serious complications, such as severe bleeding and hemorrhage, extreme uterine pain, incomplete abortions where parts of the fetus remain in the womb, and life-threatening infections. Women then face medical interventions from hospitalizations and blood transfusions to emergency hysterectomies and loss of fertility.
In 2000, the FDA failed American women and girls by sending dangerous drugs into the market. In the 22 years since, the FDA has only doubled down. The doctors represented in this new lawsuit say enough is enough.
It’s time for the FDA to be held accountable for its irresponsible approval of chemical abortion drugs. It’s time for the courts to compel the FDA to do its job: to protect the health and safety of women and girls.