Introduction

Background of Chemical Abortion Practices

The abortion industry for decades has pushed for decreased regulation for Chemical Abortions. Using Covid-19 as an excuse, they now are pushing to make Chemical Abortion pills available to all women without seeing a doctor or pharmacist. Women who are sold these drugs go home to complete the process, which results in the contents of the uterus being disposed of through wastewater, resulting in recognizable human fetal remains being regularly found in wastewater.

“Pathological Waste” is the technical term for medical waste, which includes fetal remains, body parts, organs, or other tissues from a pregnancy. “Wastewater” is used water that comes from ordinary living processes like flushing the toilet or bathing. Wastewater is commonly treated and then becomes potable water that is used in homes; alternatively, Wastewater becomes part of the groundwater if it goes into septic systems or cesspits. Pathological Waste disposal into Wastewater is prohibited almost universally, as it has significant negative health implications.

The Shady Approval & Safety Measures for Chemical Abortion

The combination of two specific drugs, mifepristone and misoprostol, for the use of Chemical Abortions was approved by the Food and Drug Administration (“FDA”) on September 28, 2000. The FDA used an accelerated medication approval process under 21 C.F.R. § 314(H) to approve Chemical Abortion. This accelerated process had only been used for thirty (30) medications before, all of which were for debilitating diseases.

The accelerated process allowed for this medication combination to be approved without testing for long-term effects, allowing unstudied harm to women who take it. The FDA implemented Risk Evaluation Mitigation Strategy (“REMS”), which is an FDA-required safety procedure, for Chemical Abortions. Generally, REMS are focused on preventing, monitoring, and managing serious risks as well as informing and educating patients to reduce risks associated with prescription medications. The FDA has only applied REMS to sixty-five (65) medications, out of nineteen thousand that are approved. These medications are subject to REMS because they have severe side effects or react dangerously to other substances.

On December 16, 2021 the FDA essentially removed the REMS requirements on Chemical Abortion, removing protections and allowing more women to access abortions with far fewer protections. Now, Chemical Abortion can be obtained by internet and mail. The FDA removed the requirement that a pregnant woman see a doctor—in person—before taking mifepristone. The FDA cites the Covid-19 pandemic as the reason that these changes are warranted.

Some drugs need REMS because they are simply more dangerous than other drugs. The Chemical Abortion cocktail is one of those. For example, Addyi, the female Viagra, is subjected to REMS. The goal of REMS for Addyi is to inform patients about the increase risk of hypotension and syncope, which is low blood pressure and the loss of consciousness caused by low blood pressure, due to the medication having an interaction with alcohol.