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Oral Argument: FDA’s Lax Abortion Drug Regulations Put Women at Risk

Posted by Tom Campisi on Apr 10, 2024 6:00:00 AM

On the steps on the United States Supreme Court, Dr. Sandy Christiansen, Care Net’s National Medical Director, was one of several voices who called out the Food and Drug Administration (FDA) for lowering the standard of care for women by removing safety requirements for dangerous abortion drugs.

On March 26, Alliance Defending Freedom (ADF) held a rally on the SCOTUS steps in conjunction with oral arguments in its case, FDA v. Alliance for Hippocratic Medicine.

Alliance Defending Freedom is representing four national medical associations and four individual doctors against the FDA for unlawfully removing crucial safety standards for pregnant women who use the abortion drugs mifepristone and misoprostol.

“We are asking the Court to hold the FDA accountable to do its job and protect women and girls from high-risk chemical abortion drugs,” said Erica Steinmiller-Perdomo, ADF Legal Counsel.

The case focuses on objections to the FDA's decisions in 2016 and 2021 to expand access to mifepristone by expanding prescription guidelines. The plaintiffs are challenging the FDA's rules regarding distribution, specifically the feasibility of prescribing it through telemedicine and sending it by mail to patients, as well as its authorization for use up to 10 weeks into pregnancy.

“Over the past eight years, the FDA has removed nearly all of its originally required safety standards that ensured women and girls had ongoing medical care while taking these high-risk drugs,” ADF stated on its website. “These safeguards included an initial in-person visit to screen for ectopic pregnancies and other serious conditions, and a follow-up visit to check for life-threatening complications like internal bleeding and infection.”

Dr. Christiansen, a board-certified OBGYN and a fellow of the American College of Obstetrics and Gynecology, said the FDA's elimination of in-person evaluation by a physician left a gaping hole in the care of women and girls taking abortion drugs.

“I've dedicated my career to health and well-being of women, and that is why I am appalled by the FDA's handling of the abortion drugs and it's stripping away of one safety standard after another,” she said.

“I meet women in the clinic who have suffered as a consequence of chemical abortion. I've heard their stories where they described feeling instant regret, waking up in a pool of blood and sometimes despairing of life itself. My heart breaks for them, and that is why I am committed to sharing the truth about these chemical abortion drugs and the impact they have on women and girls and how they can harm their physical, emotional, and spiritual health.”

At the rally, Dr. Christina Francis, a board-certified OB/GYN, said that, regardless of one’s views about abortion, “we should all agree that women deserve to have a doctor's in-person ongoing care when taking high-risk drugs.”

Francis is the CEO of the American Association of Pro-Life Obstetricians and Gynecologists, one of the four medical associations that are plaintiffs in the case against the FDA.

“The FDA has violated its duty to women after requiring critical safety standards for the use of chemical abortion drugs for 16 years, including the necessary in-person doctor visits to check for life-threatening conditions,” she said.

“My colleagues and I are on the front lines witnessing and treating the women harmed by the FDA's shameful actions. We knew we had no choice but to sue the FDA to hold it accountable.”

Dr. Christiansen said not requiring an in-person visit where a woman could receive an ultrasound was akin to medical malpractice. She presented two tragic examples of what can happen within the FDA’s current regulations:

  • “Sarah” contacted Care Net’s Pregnancy Decision Line. She told the nurse that she took the abortion drugs and was experiencing fever, chills, and dizziness. The nurse strongly encouraged her to go to the emergency room right away. At the hospital, she was diagnosed with sepsis, a life-threatening infection caused by an incomplete abortion. She needed an emergency D & C (dilation and curettage, a procedure to remove tissue from inside the uterus).
  • “Rhonda” called Care Net’s Pregnancy Decision Line after taking abortion drugs. She told the nurse that after she aborted, she tried to flush the baby down the toilet, but it was too big. She didn't know what to do.

“Rhonda's story is sadly not unique. Without a physical exam and evaluation and an ultrasound, the abortion provider had no way to know that she was actually in her second trimester,” Dr. Christiansen said. “Data has revealed four out of 10 women who take mifepristone and misoprostol beyond the first trimester need a surgical procedure to complete the abortion.”

“The FDA has left women and girls to fend for themselves, has put their health and safety in danger and has left a trail of trauma and suffering. Our women and girls deserve better. The FDA needs to make this right and reinstate safety standards.”

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