


[This is part two 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 protect the public from harmful products. But right now, the FDA is not only permitting a dangerous drug to remain on the market but is also stripping away the few safeguards that exist to protect women and girls from its harms.
That drug is the two-part chemical abortion regimen , and the story of how it entered the U.S. market is one of political pressure, cronyism, and deliberate ignorance toward both doctors’ concerns and scientific evidence.
The FDA approved chemical abortion drugs in 2000 without following proper protocols and under political pressure from the Clinton administration. And despite multiple opportunities to correct its mistake, the agency has consistently chosen to dig in its heels.
Chemical abortions have a complication rate four times that of surgical abortion — a statistic that is even more concerning because more than half of the abortions in America are chemical. Robust, reliable studies conducted in other countries about chemical abortion drugs show that 20% of women who have a chemical abortion require medical attention afterward.
Alliance Defending Freedom attorneys representing emergency room doctors from across the country have now brought a lawsuit against the FDA’s irresponsible actions. These doctors take care of women who are experiencing dangerous or life-threatening effects from chemical abortion drugs — effects ranging from hemorrhage to serious infections to the loss of the ability to have a future successful pregnancy. They care for women who have come to the emergency room after taking chemical abortion drugs with gruesome complications, including passing blood clots the size of lemons, severe cramping and pain, and serious infections caused by parts of the baby being left in the womb. Some women bleed for several weeks after taking chemical abortion drugs. Others must undergo an emergency surgical abortion.
The FDA never had the authority or the science to approve chemical abortion drugs, and it is time for a court to order the FDA to put politics aside, follow the science, and protect women and girls.
Yet the FDA insists that chemical abortions require fewer and fewer safeguards. The agency decided it did not need further studies or additional information about nonfatal adverse events from abortionists in America, and it claims that no data exist to show that the chemical abortion drugs are not safe. That position runs counter to all the evidence before doctors’ eyes. And it runs counter to the FDA’s responsibility to ensure, beforehand, the safety of the drugs it approves.
How could the FDA have approved something so dangerous?
The FDA’s initial approval of chemical abortion drugs shoehorned chemical abortion drugs into its fast-track review process for life-saving medications. The agency relied on obviously false statements to squash the drugs into this special process. For example, the organization asserted that pregnancy is an “illness” and claimed, without evidence, that chemical abortion drugs offer a “meaningful therapeutic benefit.”
Both of these claims are clearly wrong. Pregnancy is not an illness. Unlike cancer or pneumonia, pregnancy is a natural part of a woman’s life. And when it comes to describing chemical abortion drugs as offering a “meaningful therapeutic benefit,” the evidence proves the exact opposite.
Worse still, the FDA did not rely on any studies that looked at the real-world safety of these drugs in their labeled use. For example, the FDA looked at studies in which women who received chemical abortion drugs underwent ultrasounds to verify how far along they were, as these drugs become much more dangerous after seven weeks, and had multiple in-person doctor appointments to identify any contraindications.
But these conditions are not required for women seeking chemical abortion drugs. Today, if a woman receives an abortion pill, she never has to see a doctor, no one needs to conduct any tests to confirm how far along she is, and no one needs to follow up in person to ensure she’s OK. She can receive the drugs through the mail, take them alone and unsupervised, and end up in a dangerous situation — all without any input from a doctor.
The FDA has not even commissioned studies on the back end to verify that chemical abortion drugs are safe in practice. It’s almost as if the agency doesn’t want the public to know the real effects of these drugs.
The FDA has ignored its responsibility, misled the public about the risks involved in chemical abortion, and shut down discussion as these risks became apparent. Clearly, the agency cares much more about liberal government officials’ agenda than the safety of women and girls. It’s far past time the agency is held accountable.
CLICK HERE TO READ MORE FROM RESTORING AMERICAJulie Marie Blake is senior counsel for regulatory litigation with Alliance Defending Freedom (@ADFLegal).