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(10 weeks) into pregnancy and before Biden was subject to a heightened safety restriction called a Risk Evaluation and Mitigation Strategy (REMS) that requires an in-person visit with a physician who can check for dangerous contraindications such as ectopic pregnancies and can advise the mother seeking an abortion of the risks of chemical abortion, including hemorrhaging, and what to do in such circumstances. Chemical abortion has been found to have a complication rate four times higher than that of surgical abortion.

Since its approval more than 20 years ago, mifepristone has been associated with 26 deaths of pregnant mothers, over a thousand hospitalizations, and thousands more adverse events, but that number does not account for all complications. Of course, this does not count the hundreds of thousands to millions of babies whose lives have been unjustly taken through chemical abortion. FDA should therefore:

• Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women. It never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen. Furthermore, at no point in the past two decades has the FDA ever acknowledged or addressed federal laws that prohibit the distribution of abortion drugs by postal mail; to the contrary, the FDA has permitted and actively encouraged such activity.

Now that the Supreme Court has acknowledged that the Constitution contains no right to an abortion, the FDA is ethically and legally obliged to revisit and withdraw its initial approval, which was premised on pregnancy being an “illness” and abortion being “therapeutically” effective at treating this “illness.” The FDA is statutorily charged with guaranteeing the

safety and efficacy of drugs and therefore should withdraw this drug that

is proven to be dangerous to women and by definition fatally unsafe for unborn children.

As an interim step, the FDA should immediately restore the REMS by removing the in-person dispensing requirement to eliminate dangerous tele-abortion and abortion-by-mail distribution.

Mail-Order Abortions. Allowing mail-order abortions is a gift to the abortion industry that allows it to expand far beyond brick-and-mortar clinics and into