SILVER SPRING, Maryland (LifeSiteNews) – The Food and Drug Administration (FDA) announced that it is loosening restrictions on the dangerous chemical abortion drug mifepristone by removing the in-person dispensing requirement and allowing the abortion pill to be received by mail.
The drug was previously available only at specified medical facilities where it could be provided only under the direct supervision of a doctor. The precautions were taken to ensure that the woman really was pregnant when she took it, that she was not more than 9 or 10 weeks pregnant, that the pregnancy was not ectopic, and that she was not being coerced into the abortion. It also usually prevented the pills from being used to kill the unborn babies of unsuspecting pregnant women.
However, the Biden-Harris regime began active non-enforcement of that policy in April, claiming that the COVID pandemic interfered with women seeking an abortion.
The new policy alters the FDA’s previous Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. According to the FDA, its REMS safety protocol is designed to regulate “certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.” The protocol change now permits pharmacies to dispense the drug with a prescription from an approved medical provider, allowing it to be received by mail.
“Abortion activists’ longtime wish has been to turn every post office and pharmacy into an abortion center,” said Sue Liebel, State Policy Director for the Susan B. Anthony List, in a condemnation of the decision. “Women who take chemical abortion pills are significantly more at risk of serious complications and more likely to require a visit to the emergency room. Some women even die.”
Distribution of mifepristone has been restricted due to safety reasons since its original introduction under the brand name Mifeprex in 2000 and has been under the FDA’s REMS protocol since 2011. The latest CDC analysis suggests that since 2017 the chemical abortion drug has accounted for 40% of abortions annually.
The FDA also states that there have been numerous complications from using mifepristone, including 24 recorded deaths and thousands of other adverse events reported to the FDA as of Dec. 31, 2018. Analysis of the FDA’s adverse event reporting system concludes that that these figures are dramatically under counted, although by precisely how much is unknown.
A recent peer-reviewed study by the Charlotte Lozier Institute provides even more alarming statistics. It concluded: “The rate of abortion-related emergency room visits following a chemical abortion increased over 500% from 2002 through 2015, according to an analysis of Medicaid claims data.” Additionally, the study also found that “the rate of abortion-related ER visits is growing faster for chemical abortions than [for] surgical abortions.”
The FDA’s move comes a day after the Senate’s hearing of President Biden’s nominee for FDA Commissioner, Dr. Robert Califf, who was queried about mifepristone’s safety and the FDA’s deliberations about loosening restrictions on dispensing the drug. Califf responded that he had “great confidence” in the staff studying mifepristone and said they would craft any decision regarding the abortion pill based on the latest studies. Califf, however, has a previous history at the FDA of widening mifepristone’s availability without warning or provision of accompanying data.
Students for Life Action President Kristan Hawkins also denounced the administration’s calculated moves to increase chemical abortion, observing, “President Biden has stacked the deck with radical chemical abortion supporters leading America’s healthcare systems, starting with HHS Secretary Xavier Becerra who led a coalition effort against the FDA health and safety standards while he was attorney general of California, and again, in choosing Dr. Califf to head the FDA on Becerra’s watch. It’s clear that reckless change is in the works.”