New Study Exposes the Real Cost of the FDA’s Abortion-Drug Coverup

During the Biden administration, abortion advocates tried mightily to cover up the corruption and political maneuvering at the Food & Drug Administration that has promoted the drug mifepristone, which now causes nearly two-thirds of all abortions. A lawsuit seeking to expose how the FDA unlawfully approved and pushed this dangerous drug was cut short, with the Supreme Court ruling in June 2024 that the plaintiffs lacked legal standing.

Now, a shocking report has finally shown a light on how the FDA is harming, and even killing, thousands of women.

Heritage Foundation research disseminated last fall showed that emergency room visits for abortion complications have been on the rise since the FDA lifted mifepristone’s safety rules. And now, in the largest study of its kind, the Ethics and Public Policy Center has analyzed data from an insurance claims database to determine the actual incidence of serious adverse reactions to mifepristone. They looked at more than 865,000 mifepristone abortions between 2017 and 2023, 28 times as many as in all FDA clinical trials combined.

These cases occurred in the real world, not in the artificial conditions of a clinical trial. They involved women of all backgrounds and circumstances, not the limited subjects designed by the FDA. And these cases were from after the FDA began dropping its safety precautions, the real test of how this drug actually impacts women.

The result? Nearly 11% of women had serious adverse reactions within 45 days of the abortion. That’s 22 times the complication rate that the FDA claims on the drug label. So the FDA rigged the complication data to falsely claim the drug is safe, leaving women unprotected from the real and serious risks that we now know were devastating their lives as well as killing babies.

This was bound to happen. After all, mifepristone has been embroiled in controversy for 25 years. The FDA approved its marketing and use in 2000, but only under unusual circumstances. Because its many side effects and risks meant it could not be approved through the FDA’s regular evaluation process, abortion advocates pressured the FDA to use a separate fast-track procedure usually reserved for drugs that treat life-threatening illnesses such as HIV or cancer.

The gimmick worked. The FDA approved mifepristone without any evidence about how it would affect minors, even though it was to be prescribed for all pregnant females. The FDA’s approval, however, still came with significant safety restrictions. These included its use limited to the first seven weeks of pregnancy, mandatory in-person doctor visits, and administration of the drug in the presence of a health care provider.

The coverup continued as the FDA ignored a petition submitted by medical groups challenging the approval. Though the law required a response within 180 days, the FDA looked the other way for 14 years.

On the same day it denied the petition, the FDA started lifting the safety precautions that had been in place for more than a decade. It allowed non-physicians to prescribe and administer the drug, reduced the number of doctor visits, and canceled the requirement that most medical complications be reported.

It took these steps with no evidence about how dropping multiple safety rules at the same time would affect the drug’s safety and effectiveness.

The FDA let the remaining safety precautions go five years later, allowing women to obtain mifepristone by mail or through mail-order pharmacies. The separation of women and doctors was complete: women could get a prescription for mifepristone, as well as obtain and use the drug, without any actual face-to-face meeting with a doctor.

As shocking as this is by itself, the FDA’s claimed reason for it is even more outrageous. Having dropped the requirement that non-fatal complications be reported, the FDA now said that the lack of data on non-fatal complications justified dropping the safety precautions!

Abortion advocates have been lying for years about how, in addition to killing unborn babies, mifepristone is harming women. The FDA claimed, based on a small number of clinical trials, that only 0.5% of women using the drug had “serious adverse reactions” such as infection, hemorrhage, ectopic pregnancy, or incomplete abortion. The FDA, of course, had guaranteed that this figure would be as low as possible by making any reporting of such complications voluntary.

Women are paying the price for the FDA’s choice to put politics ahead of sound medicine. From a sneaky approval process and lack of relevant evidence to the sleight-of-hand of claiming that the lack of evidence of complications that doctors no longer need provide means that the drug is safe after all. That’s the medical version of a man killing his parents and then asking for mercy because he’s an orphan.

But this is no joke. Women are led to believe that abortion drugs are safe and that they can obtain and use them safely without any real interaction with doctors. They realize that this was a lie only when they end up in the emergency room bleeding, infected, and perhaps still needing a surgical abortion.

This is the real cost of FDA corruption.

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