Chemical Abortion: FDA Ignores ‘Inconvenient’ Science and Data Confirming Public Health Threat

Major Studies Link Chemical Abortion to Higher Rates of Emergency Room Utilization and Complications

Washington, D.C. – The U.S. Food and Drug Administration (FDA) today announced plans to irresponsibly erode longstanding patient safeguards on the abortion pill, despite major U.S. and international research confirming that chemical abortion has led to a surge in emergency room visits and higher rates of complications.

Tessa Longbons, senior research associate at Charlotte Lozier Institute (CLI), had this reaction:

“The FDA claims the abortion pill is safe, yet peer-reviewed research confirms a 500% increase in the rate of chemical abortion-related emergency room visits.  The FDA claims that complications are rare, yet peer-reviewed research from the United States, Finland, and Sweden confirms the abortion pill has a much higher complication rate than surgical abortion.

“As a woman who has studied abortion trends on a state-by-state level and analyzed major studies on chemical abortion, I find today’s FDA decision to be historically bad.  The FDA is putting women and girls at considerable risk through regulatory malpractice.”

CLI recently published a first-of-its-kind longitudinal study of Medicaid claims data from 17 states where state taxpayer funds pay for abortion.  After analyzing 423,000 confirmed abortions and 121,283 confirmed emergency room visits within 30 days of the abortion, CLI researchers found:

• The rate of abortion-related ER visits following a chemical abortion increased 507% from 2002-2015.
• Chemical abortion significantly increased the risk of an emergency room visit. Within 30 days of a chemical abortion, when compared to rates following a surgical abortion:
  • 22% greater risk of ER visit for any reason.
  • 53% greater risk of ER visit for an abortion-related reason.
• Over 60% of abortion-related ER visits following a chemical abortion in 2015 were miscoded as treatment for a miscarriage.
  • The sequence of confirmed chemical abortion, subsequent pregnancy, and subsequent miscarriage within 30 days is physically impossible. The high rate of miscoded chemical abortion visits suggests the FDA’s data on adverse events is flawed.

Dr. James Studnicki, CLI’s Vice President of Data Analytics and lead author of the study, explained:

“This publicly-available Medicaid claims data is more comprehensive than anything available from the FDA or the abortion industry.  For example, starting in 2016, the FDA chose to only require reports of death associated with the abortion pill, making their dataset woefully incomplete.

“Incomplete data leads to bad decisions.  Today’s FDA decision ignores several sets of much more substantial data which confirms the abortion pill is a significant public health threat, and the real-world data suggests that threat is growing.”

The peer-reviewed study of Medicaid data was published recently in the journal Health Services Research and Managerial Epidemiology.  The 17-year longitudinal analysis (1999-2015) covered the time period from shortly before FDA approval of Mifeprex (the abortion pill) through the most recent data available.

Separate peer-reviewed studies using comprehensive datasets from California, Finland, and Sweden confirm chemical abortion is linked to higher rates of complications than surgical abortion.

• A study of 42,619 abortions in Finland found that chemical abortion has a complication rate four times greater than surgical abortion and that a fifth of all chemical abortions result in complications.
• A study from Sweden found that complications related to chemical abortions at less than 12 weeks gestation “increased significantly during 2008-2015 without any evident cause.”
• A retrospective observational cohort study using California Medicaid data found a major complication rate of 5.2% for chemical abortion but just 1.3% for first-trimester aspiration abortion, or a complication rate for the abortion pill that is four times greater than surgical abortion.

CLI Executive Director Stephen Billy said:

“The science is clear.  Abortion ends a human life, and chemical abortion puts the life of the mother in much greater danger.  What’s also clear today is the Biden FDA is cherry-picking flawed data to give the abortion industry a Christmas gift. They could call Medicaid and get the same publicly-available data that Lozier Institute scholars studied showing that chemical abortion has led to a surge in emergency room visits.  Instead, they increased the risk to women’s health.

“The FDA’s decision is a stark contrast to pro-life pregnancy centers, which provided women and families with over $266 million in tangible support in 2019.  As a community, let’s do better than the FDA and continue providing women and children with care and support.”

Charlotte Lozier Institute was launched in 2011 as the education and research arm of Susan B. Anthony List.  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. 

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