[This is part three 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.]

In 2000, the Food and Drug Administration failed in its duty to protect the American public with its initial approval of chemical abortion drugs. But in the decades since, it has added insult to injury. Presented with two clear opportunities to correct course and protect American women and girls from these dangerous drugs, the FDA chose, both times, to ignore the evidence and silence the voices of concerned citizens.

When the FDA first approved the chemical abortion drugs mifepristone and misoprostol in 2000, it sidestepped the required studies—including studies that look specifically at risks for teenage girls—and wrongly categorized the drugs as offering a “meaningful therapeutic benefit.” The FDA justified its reckless approval by claiming that pregnancy is a “life-threatening or serious illness.”

In 2002, two professional medical associations filed a citizen petition, challenging the FDA’s initial approval and asking the agency to complete the studies it had neglected to perform, particularly the pediatric studies. The petition included dozens of pages of testimony and evidence of the dangers of chemical abortion.

With this petition, the medical associations pointed out that the FDA had overstepped its authority when it approved chemical abortion drugs. The petition asked that the FDA simply confine itself to the limits of its authority, and — because a dangerous, unstudied drug was on the market — it requested that the drug’s approval be withdrawn until the FDA did its due diligence.

This seems like a sensible request, but for 14 years, the FDA didn’t bother to respond to the serious concerns identified in the petition. Instead, the FDA chose to put politics over science. The FDA simply stonewalled and apparently hoped that the whole thing would blow over.

Finally, in 2016, after nearly a decade and a half of silence, the FDA denied the citizen petition in a flurry of hand-waving. On the very same day, as a slap in the face to the many women who had been harmed by chemical abortion drugs since 2000, the FDA approved major and dangerous changes to the chemical abortion drug regimen in response to a request from Danco Laboratories, the corporation that manufactures chemical abortion drugs.

These changes served to remove most of the few remaining safeguards on chemical abortion drugs and to make it more likely that a contraindication or a severe adverse effect would be missed and get out of control. The major changes included increasing the allowed gestational age from 49 days to 70 days, despite the fact that adverse effects skyrocket as pregnancy goes on; removing the in-person follow-up requirement, meaning that women might never see the prescribing healthcare worker again, despite any adverse effects; allowing “healthcare providers” other than physicians to dispense and administer these drugs; and so on.

The FDA did all this despite the fact that chemical abortions have a complication rate of four times that of surgical abortions. It ignored the reality that at least 20% of women who use chemical abortion drugs will have to seek medical help afterward. In fact, the FDA facilitated the burial of those women’s stories. As part of the major changes, the FDA eliminated the requirement for healthcare workers to report nonfatal adverse effects from chemical abortion drugs. Hemorrhage? Massive infection? Incomplete abortion requiring surgery? Loss of fertility from a chemical abortion? The FDA doesn’t want to hear about it.

Following the 2016 changes, the medical associations submitted another citizen petition, this time with the American College of Pediatricians, asking the FDA to restore the safeguards it had eliminated at the behest of Danco. Instead, in 2019, the FDA approved a generic version of mifepristone for common use.

Then in 2021, the FDA began allowing women to receive chemical abortion drugs through the mail, meaning that women no longer needed to have an in-person exam with a prescriber before receiving these drugs. The agency pointed to the lack of reported adverse events in the past few years — conveniently not mentioning, however, that it had gutted its reporting requirements for adverse effects in 2016.

The FDA denied the substance of the second citizen petition, making it clear that only certain voices — namely pro-abortion voices — are respected at the FDA when it comes to chemical abortion.

That is why, last year, four doctors and four national professional medical associations represented by attorneys with Alliance Defending Freedom filed a lawsuit asking the courts to hold the FDA accountable. The lawsuit shows how the FDA has refused to pay attention to the medical evidence that chemical abortion drugs harm women and children while it has catered to the requests of pro-abortion groups and interested corporations.

The FDA has a responsibility to the public: to protect Americans by ensuring that medical products on the market are safe. It has failed in that responsibility. It’s up to the courts to keep the FDA within the bounds of its authority and keep it accountable to the people it exists to serve.

Julie Marie Blake is senior counsel for regulatory litigation with Alliance Defending Freedom ( @ADFLegal ).