A new abortion pill lawsuit filed by a group of pro-abortion attorneys general against the U.S. Food and Drug Administration (FDA) claims the government agency “unnecessarily singl[ed] out the abortion drug mifepristone for excessive regulation” by keeping it under the FDA’s REMS safety system. The abortion pill is estimated to have ended the lives of over 500,000 preborn babies in 2020 alone.
“The Attorneys General are also seeking a preliminary injunction, asking the court to stop FDA enforcement of the REMS while the lawsuit is pending,” the group’s press release claimed. The suit was led by pro-abortion Oregon AG Ellen Rosenblum and Washington AG Bob Ferguson, later adding 10 others. In their complaint, the 12 state AGs contend that the “FDA has continued to hamper access by singling out mifepristone… for a unique set of restrictions known as a Risk Evaluation and Mitigation Strategy (REMS).”
The FDA’s website states that REMS is a “drug safety program that the [FDA] can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. While all medications have labeling that informs health care stakeholders about medication risks, only a few medications require a REMS.”
FDA kept abortion pill under REMS during tenure of pro-abortion Democrat presidents
The abortion pill mifepristone (Mifeprex) was approved under the leadership of pro-abortion then-President Bill Clinton in 2000.
Live Action News has previously detailed the FDA’s concerns over the safety of the abortion pill in past years, which included a serious infection and the death of several women shortly after the regimen was approved. This is why in April 2011, under President Barack Obama’s FDA, the agency determined that the safety requirement known as REMS was necessary for mifepristone.
Then, under 2016 changes, Obama’s FDA again kept the drug under the REMS, while extending the gestational age the drug could be prescribed. Obama’s FDA then weakened the REMS by no longer mandating that abortion pill manufacturers Danco Laboratories or GenBioPro (the pill’s generic manufacturer) notify the FDA of complications (adverse events) other than death.
Therefore, there is no way to truly know the number or types of adverse events that have taken place due to the abortion pill after 2016.
In 2021 and again in 2023, President Joe Biden’s FDA chose to keep the drug under the REMS but also weakened the safety requirements by allowing the drug to be permanently shipped by mail and enabling retail pharmacies to dispense the drug with a prescription.
Dueling complaints
Rosenblum/Ferguson’s lawsuit states, “More than 22 years ago, the United States Food and Drug Administration (FDA) approved mifepristone (under the brand name Mifeprex) to be used with the drug misoprostol, in a two-drug medication regimen to end an early pregnancy. Approval was based on a thorough and comprehensive review of the scientific evidence, which established that mifepristone is safe and effective.”
“FDA’s decision to continue these burdensome restrictions in January 2023 on a drug that has been on the market for more than two decades with only ‘exceedingly rare’ adverse events has no basis in science,” the complaint reads. “It only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the Plaintiff States and their health care providers to dispense.
Meanwhile, a separate challenge against the FDA by Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), the Christian Medical & Dental Associations, and the American College of Pediatricians, and filed by the Alliance Defending Freedom (ADF), alleges that “By illegally approving chemical abortion drugs, the U.S. Food and Drug Administration failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.” As a result, they claim, women and girls have been harmed by the abortion pill regimen.
“The FDA 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,” ADF’s website on the lawsuit claims.
In their complaint against the FDA, the pro-abortion AGs are regurgitating previously debunked claims that the abortion pill is ‘safer than Tylenol’, writing in their lawsuit, “Mifepristone is safer than many other common drugs FDA regulates, such as Viagra and Tylenol.”
Read the full lawsuit here.
Politicized FDA?
Live Action News has previously documented how the FDA politicized the abortion pill’s approval process two decades ago by choosing not to publish the names of the “experts” who reviewed the drug.
The names of the FDA staff involved with approving the abortion pill have never been released.
Abortion industry insiders, including one who actively worked on clinical trials for pharmacy dispensing reviewed by the FDA, are calling for women to lie and claim to be experiencing a natural miscarriage when presenting to an emergency department with an abortion pill-related complication. They are also calling on emergency room staff to falsify documents that inevitably protect abortion providers.
Changes made by Biden’s FDA to the abortion pill’s January 2023 label appear to be in lockstep with these unethical suggestions, since the label now eliminates important instructions from the black box warning and the patient counseling section. The warning used to urge women bring their medication guide to an emergency room in the event of a complication, but no longer does. Read more about that here.
Abortion Pill Label Changes 2023 no longer tells women to bring medication guide to ER
Abortion pill label changes (2019 to 2023) edits to Black Box Warning and counseling section
A new Live Action News series will document the fact that despite minimal REMS requirements for the abortion drug, the abortion industry continues to flout these provisions by prescribing the pill past the approved gestational limits, changing regimens, and failing to properly date gestational age as well as rule out dangerous ectopic pregnancies before prescribing abortion pills, among other things.
Yet, those tasked by the FDA with policing prescribers and dispensers of the drug (Danco and GenBioPro) appear to have done little to nothing to require strict adherence to the safety requirements. Read the first article in the series here.
Live Action News will publish updates as these lawsuits proceed.
