Unsafe: FDA Ignores Major Flaws in Abortion Pill Approval

FOR IMMEDIATE RELEASE: February 14, 2023

Contact: Mary Owens, [email protected]

Pro-Life Doctors & Advocates: FDA’s Recklessness Undermines Informed Consent Principles

Washington, D.C. – In a brief submitted Friday, Susan B. Anthony Pro-Life America and several national organizations representing pro-life doctors and health care professionals urged a federal district court to address fundamental flaws in the U.S. Food and Drug Administration’s approval of the abortion pill regimen by granting a preliminary injunction to protect the health and safety of women and girls.

In November, a group of doctors led by the Alliance for Hippocratic Medicine sued the FDA for its reckless and inadequate screening of the dangerous abortion drug regimen utilizing mifepristone and misoprostol, and its progressive removal of restrictions designed to enhance safety for women. The case is Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.

“A woman or girl cannot consent to a chemical abortion without knowing the specific risks that mifepristone poses to her life, health, and fertility,” SBA Pro-Life America’s brief argues. However, flaws in the clinical trials used to approve the drug, as well as ongoing deficiencies in the reporting of abortion pill-related complications, make full informed consent impossible.

  • Patients in the clinical trials received standard medical screenings, including ultrasounds, physical exams and blood work, which help protect women against known complications. Yet these safeguards are not included on the mifepristone label and are not required for telemedicine abortions.
  • The FDA eliminated reporting requirements for non-fatal complications in 2016, meaning that prescribers, women and girls, and even the FDA don’t have complete data on the total number of complications caused by chemical abortions, including severe or life-threatening complications.
  • Without in-person contact, prescribers cannot adequately screen patients for coercion and abuse, further undermining the general principles and purposes of informed consent protections.

SBA Pro-Life America President Marjorie Dannenfelser commented:

“Mail-order abortion drugs are not safe – they pose serious risks to women’s health and safety as well as threatening the lives of countless unborn children. The FDA exists to protect the American public from dangerous drugs, yet time after time, they have ignored the data and put pro-abortion politics before safety. We support the courageous doctors who are standing up for patients everywhere, and we encourage our state and federal allies to continue fighting to stop the reckless expansion of chemical abortion drugs.”

Chemical abortion, sometimes called “the abortion pill,” is a two-drug regimen taken up to 70 days (10 weeks) or even later into pregnancy and causes the death of the unborn child. The first drug, mifepristone (Mifeprex or RU486) blocks the natural hormone progesterone, starving the developing baby of hormonal support, while the second drug, misoprostol (Cytotec) induces labor to expel the baby from the womb.

Scientists and doctors from the Charlotte Lozier Institute also filed an amicus brief in the case that details more than a dozen specific concerns with the FDA’s flawed approval.

Major international studies show that the abortion pill regimen carries four times the risk of complications as surgical abortion. Peer-reviewed research from the Lozier Institute has also foundthat after a chemical abortion there is a 53% greater risk for an ER visit for abortion complications than after a surgical abortion.

For more information on the dangers of chemical abortion, visit abortiondrugfacts.com.

Susan B. Anthony Pro-Life America is a network of more than one million pro-life Americans nationwide, dedicated to ending abortion by electing national leaders and advocating for laws that save lives, with a special calling to promote pro-life women leaders.




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