Heartbeat International has weighed in on a case in federal court with implications for states’ rights to regulate chemical abortion pills.
Heartbeat filed an amicus brief August 19 in Bryant v. Stein urging the U.S. Court of Appeals for the Fourth District to reverse a district court decision finding that federal law preempts North Carolina’s law regulating chemical abortion and to affirm the law to the extent the district court had left the regulation in place. The right for states to set abortion policy was reaffirmed with the 2022 Dobbs ruling overturning Roe v. Wade.
“FDA regulation does not mark the beginning and the end of protections for an individual’s health in a medical setting,” the Heartbeat brief argues, and “the states also have a primary role in the regulation of medical care …” The legal non-profit Thomas More Society (TMS) filed the brief on behalf of Heartbeat International.
“North Carolina’s laws protecting the unborn from abortion are not preempted,” the document states. “Moreover, the chemical abortion regimen approved by the FDA presents great risks to pregnant women. Nothing about the FDA’s approval of a drug demands that a state permit the procedures in which the drug may be used.”
Heartbeat’s brief goes on to argue that chemical abortion “is dangerous to women and legitimately subject to being outlawed or otherwise regulated by a state, such as North Carolina.”
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In the last several years the FDA had removed numerous longtime safeguards that were in place for chemical abortion drugs since their approval in 2000, including the in-person dispensing requirement and abolishing the requirement for prescribers to report non-fatal complications—which can include extreme bleeding and injuries that require hospitalization.
Though estimates vary, they all say chemical abortions account for a majority of abortion conducted in the U.S., and the percentage continues to grow with open access to the drugs.
In U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, a group of pro-life doctors and organizations challenged the FDA's decision to remove those remove key health and safety measures from the prescribing requirements for chemical abortions. The U.S. Supreme Court ruled in June that the doctors did not have standing - but upheld their conscience rights and also refrained from ruling on the merits of the case, leaving the door open for other parties to take up the case. Three states that were allowed to join the case in January of this year could continue with the case.
Heartbeat had also weighed in on FDA v. AHM with an amicus brief filed to the U.S. Supreme Court arguing that the FDA put women at risk by lowering the standard of care for treating pregnant mothers when it relaxed its own rules for chemical abortion drugs in 2016 and 2021.
In Bryant v. Stein, legal non-profit Alliance Defending Freedom (ADF) had intervened on behalf of Speaker of the North Carolina House of Representatives Timothy K. Moore and President Pro Tempore North Carolina Senate Philip E. Berger. ADF stated of the FDA removing the safety protocols, “This puts the health and safety of women and girls at risk.”
North Carolina law requires a doctor be present to administer the chemical abortion pill and to conduct an ultrasound to determine the gestational age of the unborn child or diagnose ectopic pregnancy. Informed consent from the woman seeking an abortion prior to administering the drugs is also required and the law mandates a 72-hour waiting period as well.
An abortion provider had sued the state of North Carolina in January 2023 over these protections, challenging five laws intended to protect women’s health and safety.
“The abortionist has wrongly claimed that the FDA’s approval of chemical abortion drugs and removal of safeguards supersede North Carolina’s ability to implement their own protections against the dangerous drugs,” ADF’s statement said. “The Dobbs ruling makes clear that states can enact pro-life laws to protect women and unborn children against the dangers of abortion.”
In addition to requiring that women be informed of medical risks of infection, hemorrhage, infertility, and psychological harm possible with chemical abortion, and the gestational age of their unborn baby, North Carolina’s informed consent provision requires they be given the opportunity to see a real-time view of their unborn baby and heart-tone monitoring. Information on financial assistance programs and alternatives to abortion, as well as being made aware that they are free to withhold or withdraw their consent to the abortion any time before or during the abortion are also provided for.
A federal judge for the Middle District of North Carolina ruled April 30 that the FDA was the entity authorized to make such safety determinations about the abortion pill and that it had already explicitly considered and rejected the safeguards the state sought to enact.
Heartbeat International, the largest network of pregnancy help organizations both globally and in the U.S., manages the Abortion Pill Rescue Network (APRN), consisting of more than 1,400 healthcare professionals, pregnancy centers, and hospitals that administer the Abortion Pill Reversal (APR) protocol.
The APRN provides assistance for women who have started, but not yet completed, the chemical abortion process and wish to continue their pregnancies.
Chemical abortion consists of the drug mifepristone, which blocks progesterone in the woman’s system, starving the unborn child of necessary nutrients. The second drug, misoprostol, taken a day or so later, caused the woman to go into labor and deliver her presumably deceased child.
APR entails prescribing bioidentical progesterone to the woman after she has taken mifepristone to counter the abortion drug. It is an updated application of a treatment used since the 1950s to combat miscarriage. Statistics show that more than 5,000 lives have been saved through the Abortion Pill Rescue Network.
The APRN answers more than 150 calls per month from women who have started a chemical abortion, regretted their decision, and who are seeking to save their pregnancy.
Tweet This: Chemical abortion is dangerous to women and legitimately subject to being outlawed or otherwise regulated by a state.
Heartbeat states in its amicus brief in Bryant v. Stein that “given its regular interactions with women who have obtained chemical abortion drugs they later regret ingesting, Heartbeat is uniquely positioned to provide relevant factual background on the impact of having safeguards for chemical abortions.”
Heartbeat argues that the FDA’s regulations for chemical abortion drugs leave significant gaps in protections for pregnant women. The international pregnancy help network says as well that conducting chemical abortion without an ultrasound results in serious risks to maternal health, as does providing chemical abortion without follow-up treatment.
Women who undergo chemical abortion without prior in-person counseling are at an increased risk for abortion regret and emotional or psychological complications, the Heartbeat brief states. Additionally, it says, women who undergo chemical abortion are at an increased risk of coerced or forced abortions.
There are many reasons states may have to protect the dignity of the unborn, Heartbeat told the court, and North Carolina’s chemical abortion regulations protect women’s health.
In addition to the possibility of the mifepristone case before the Supreme Court continuing, another case before the Fourth Circuit, GenBioPro v. Raynes, could has potential implications for abortion drug access. Heartbeat International filed an amicus brief in that case as well, arguing that FDA regulations for mifepristone do not preempt the West Virginia’s Unborn Child Protection Act and other state law.
Editor's note: Heartbeat International manages the Abortion Pill Rescue® Network (APRN) and Pregnancy Help News. Heartbeat is currently the subject of two lawsuits brought by state Attorneys General concerning charing information about Abortion Pill Reversal.
