Good morning!  I am Tami Fitzgerald, Executive Director of the NC Values Coalition, a statewide pro-life organization in the great state of North Carolina.

The FDA recklessly endangered women’s health by removing the safety standards it once deemed necessary to ensure the health and safety of women and girls using abortion drugs. This removal of safety standards has been a deliberate move toadvance the agenda of the abortion industry, as it seeks to transition, facilitating more and more do-it-yourself abortions by the use of drugs instead of physician-assisted abortions by a scalpel or suction.

NC Values Coalition’s sister organization, Institute for Faith and Family, filed an Amicus Brief in this case.

In 2000, the FDA approved the use of chemical abortion drugs only with several safety standards.

Then, in 2016, without sufficiently evaluating the impact on women’s health, the FDA egregiously removed most of these safety precautions:

In 2016, the FDA removed most of these safety precautions:

  • Instead of requiring the three in-person doctor visits, as initially required, including follow-up visits to check for serious complications like life-threatening infections and severe bleeding, the FDA reduced care for women to only one in-person doctor visit at the beginning of the chemical abortion process;
  • Instead of only allowing a doctor to prescribe abortion drugs to pregnant women as initially required, the FDA broadened the requirement to allow nurse practitioners and other healthcare professionals to prescribe the drugs;
  • Instead of the seven-week threshold as initially required, the FDA allowed the use of the drugs up to ten weeks, even though the FDA’s own data shows that the likelihood of complications with the drugs increases each week of pregnancy; and
  • The FDA eliminated its previous requirement that prescribers report all serious complications from these drugs.

In 2021 the FDA abandoned the last remaining in-person office visit that ensured women do not have ectopic pregnancies and other life-threatening conditions before taking abortion drugs, acknowledging that women harmed by these drugs would need to rely on overcrowded emergency rooms and conceding that studies used to justify the decision were “not adequate.”

This has left women to have abortions at home without the care and supervision of a physician.

Women should have the ongoing care of a doctor when taking high-risk drugs, and the FDA betrayed women and girls when it removed the necessary in-person doctor visits that protected women’s health and well-being.

Doctors have witnessed firsthand the harm to women and girls caused by the FDA’s reckless actions. Without a medical examination, gestational age and life-threatening ectopic pregnancies cannot reliably be detected. One in 25 women who have chemical abortions will end up in the emergency room.

Women and girls are promised the affects will liken a heavy period, but reported affects include weeks of heavy bleeding, excruciating cramping, nausea, and delivering their babies at home. One woman said, “They didn’t tell me I would see hiseyes and his fingers. They didn’t tell me I would be holding my dead baby.” Women and girls also aren’t told they will experience labor without a doctor’s help as they suffer alone in their bathrooms, which have become their in-home abortion clinics.

The current FDA policies also violate rights of conscience by forcing emergency room doctors to finish abortions started with abortion drugs at home.

In North Carolina, 66% of abortions are chemically induced. Thankfully, North Carolina’s SB 20, the “Care for Women, Children and Families Act” was passed last year which requires women to be examined by a doctor before being prescribed chemical abortion drugs, and only a doctor may prescribe the drugs.

Women and girls across the country have suffered severe, even life-threatening, complications because of the FDA’s lawless actions. While there is no such thing as a safe chemical abortion because a life is always taken, the FDA must be held accountable for violating its duty to protect women and girls.

It is time for the Supreme Court to require the FDA to do its job—to put an end to the FDA’s shameful actions and utter disregard for women and girls.  It’s time for the FDA to put women first—to put back those essential safeguards.  And to actually commit to protecting women’s health instead of leaving women to suffer tremendous pain never insuring that they have a doctor to care for them in person during an immensely difficult, challenging, and painful time.  Women deserve better.  It’s time for the FDA to do better.