Scientists Ask U.S. District Court to Suspend Sale of Dangerous, Poorly Tested Abortion Pills

‘The FDA has made an unjustifiable and unreasonable risk-benefit assessment regarding chemical abortion’

Washington, D.C. – With major international studies showing that the abortion pill regimen carries four times the risk of complications as surgical abortion, Charlotte Lozier Institute has filed an amicus brief asking the U.S. District Court for the Northern District of Texas to grant a preliminary injunction suspending the Food and Drug Administration’s (FDA) approval of the abortion pill.

The Lozier Institute amicus brief, filed in the Alliance for Hippocratic Medicine v. FDA case (AHM v. FDA) details more than a dozen specific concerns with the FDA’s flawed approval.  The brief reads in part:

“Yet the consequences of telemedicine chemical abortion are almost too numerous to count – lack of necessary ultrasounds to confirm gestational age and rule out ectopic pregnancy, inability to confirm that a woman is not being coerced to obtain an abortion, abandonment of women to deal with the medical and psychological repercussions of abortion by herself with no follow-up, and grave harm to physicians who are expected to clean up the mess (in the ER and elsewhere) of self-managed abortion.

 

“No benefits outweigh these tremendous risks.”

Key arguments in the Lozier Institute brief include:

• The abortion pill is approved for use on young girls, even though the FDA ignored its own rules by performing no studies focused on girls under the age of 18.

“Even today, more than two decades after the FDA approved the drug for abortion, no studies specific to the pediatric population have been performed.  What is the effect of using an endocrine disruptor that blocks progesterone in a developing adolescent?  Could this impair sexual development or lead to impaired fertility later in life?  Does it work differently in an adolescent than an adult woman?  No one knows.”

• The FDA approved telemedicine abortions in 2021 based on studies that utilized physical examinations and ultrasounds, which are not required for telemedicine.

“The FDA justified the 2021 changes with studies that purportedly found similar outcomes after comparing telemedicine abortions to in-person abortions.  But many of the ‘telemedicine’ abortions in these studies implemented standard pre-abortion screening, including physical exam, ultrasound, and labs.  In other words, these studies did not look at true telemedicine abortions (the type that the 2021 changes permit) where the woman is never seen by a physician in person and thus does not have ultrasound, physical, or labs.  The supposed ‘telemedicine abortions’ in the studies only differed from in-person abortion in that the abortion pills were provided to the woman by mail or through a local pharmacy instead of directly from the abortion provider during an in-person visit.”

• Distribution of the abortion pill regimen via the mail or telemedicine puts women at increased risk of coercion and abuse.

 

“With limited visibility and an inability to detect unspoken body language, there is no way to ensure than an abuser standing off-screen is not pressuring the woman to request an action that she does not desire.  There is not a way to document that the woman making the request is the person who will receive the abortion or to document that she is even pregnant.”

The Lozier Institute brief was based on the extensive research of Dr. Ingrid Skop, M.D., FACOG, and Dr. James Studnicki, Sc.D., MPH.

Dr. Ingrid Skop, who serves as director of medical affairs at the Lozier Institute, is a practicing, board-certified OB/GYN who has delivered more than 5,000 babies and personally treated many abortion pill-related complications:

 

“I’ve performed at least a dozen surgeries on women who experienced complications when the abortion pill regimen failed, including one emergency surgery just last month.  I’ve cared for women who took mifepristone and misoprostol to induce an abortion and required blood transfusions or treatment for severe infections.

 

“Planned Parenthood and the FDA turn a blind eye to what happens in the real world when these dangerous drugs are given to women with little or no supervision.  Typically, the abortionist isn’t providing follow-up care.  Instead, these women are ending up in already over-worked emergency rooms with complications that the FDA doesn’t even bother to track.

 

“The dangers of the abortion pill regimen are readily apparent to anyone who cares to truly look.”

Dr. James Studnicki, Sc.D., MPH, Lozier Institute’s vice president of data analytics and lead author of groundbreaking studies on the real-world impact of the abortion pill regimen, said:

“The safety of chemical abortion is greatly exaggerated.  The largest and best available U.S. data shows that abortion pill-related emergency room visits have skyrocketed more than 500%.  Many of those abortion pill-related complications are being miscoded as natural miscarriage, which masks the true impact of the abortion pill and also makes those women twice as likely to be admitted for surgery for retained products of conception.

 

“The increasing dominance of chemical abortion and its disproportionate contribution to emergency room morbidity is a serious public health threat, and the real-world data suggests that threat is growing.”

Over a span of four decades, Dr. Studnicki held academic appointments at the Johns Hopkins University School of Hygiene and Public Health, the University of South Florida College of Public Health, and the University of North Carolina, Charlotte, where for ten years he served as the Irwin Belk Endowed Chair in Health Services Research.

The national pro-life group Susan B. Anthony Pro-Life America also filed an amicus brief in the AHM v. FDA case.  Signed by several national organizations representing pro-life doctors and health care professionals, SBA Pro-Life America’s brief joins the Alliance for Hippocratic Medicine et al.’s Motion for Preliminary Injunction in calling on the Court to suspend FDA’s approval of the abortion pill regimen.  The SBA Pro-Life America brief also highlights that Informed Consent cannot be obtained due to FDA’s flawed conclusion of the abortion pill regimen’s safety, the agency’s move doing away with in-person requirements for prescribers puts women and girls at risk for complicating factors, and prescribers are unable to screen for coercion.

The “abortion pill,” also known as “chemical abortion” or “medication abortion” is actually a two-drug regimen.  When used for abortion, mifepristone (also known as Mifeprex or “RU-486”) is taken first to kill the baby by cutting off hormonal support.  Misoprostol (also known as Cytotec) is then used to induce contractions to expel the dead baby from the uterus.  The AHM v. FDA case only pertains to the use of mifepristone and misoprostol to induce an abortion.

For more information on the dangers of chemical abortion, visit Lozier Institute’s AbortionDrugFacts.com.

Charlotte Lozier Institute was launched in 2011 as the education and research arm of Susan B. Anthony Pro-Life America. CLI is a hub for research and public policy analysis on some of the most pressing issues facing the United States and nations around the world. The Institute is named for a feminist physician known for her commitment to the sanctity of human life and equal career and educational opportunities for women.

###