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Heartbeat tells SCOTUS FDA has “lowered the standard of care for women” in relaxing abortion pill safety standards’

by | Mar 8, 2024

By Lisa Bourne

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, Heartbeat International argued to the U.S. Supreme Court this past week.

Heartbeat, the largest network of pregnancy help organizations in the U.S. and globally, argued that the U.S. Food and Drug Administration’s actions have increased the risk of medical complications and harm to the physical and mental health of women, as well as creating greater risk for coerced or forced abortions, due to the lack of medical oversight with chemical abortion pills and pervasive availability of the drugs.

Heartbeat, represented by the Thomas More Society, filed an amicus brief Feb. 29, asking the Supreme Court to affirm the U.S. 5th Circuit Court of Appeals ruling from Aug. 16, 2023, that the FDA must reinstate safeguards for chemical abortion drugs and prohibit their shipment by mail. Heartbeat asked the Court to remand the U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine case for further proceedings.

In FDA v. AHM a group of pro-life doctors and organizations challenge the FDA’s decision to remove key health and safety measures from the prescribing requirements for chemical abortions. The Supreme Court will decide whether the FDA violated the Administrative Procedures Act when it changed the REMS (Risk Evaluation and Mitigation Strategies) for the chemical abortion regimen.

The chemical abortion regimen consists of two drugs, mifepristone and misoprostol, the first drug working to block progesterone in a pregnant woman’s system, starving her unborn child of nutrients, and the second drug causing her to go into labor and deliver her presumably deceased child.

Pro-life medical professionals and advocates argue that the approval process for mifepristone in 2000 was rife with politics, rushed, and below standard.

The scenario with chemical abortion drugs has become even more risky with the FDA loosening safety standards in 2016 to increase the maximum gestational age for mifepristone use from seven weeks to 10, allow non-physicians to prescribe and administer the drug, remove the requirement that misoprostol be administered in person on day 3 of the regimen, remove the requirement that the patient be seen 14 days later to check for complications, and remove a requirement to report non-fatal adverse events.

The FDA then further relaxed the rules for mifepristone in 2021, citing the COVID-19 pandemic, stating that it would allow “dispensing of mifepristone through the mail . . . or through a mail-order pharmacy.” Pro-life advocates say this latter development is ripe for abuse through the forcing or coercing of unwanted abortions upon women.

“The FDA has determined, with no explanation, that it is safe to prescribe chemical abortion drugs to women even though their pregnancies might be unconfirmed, suboptimally dated, or dangerous ectopic pregnancies for which the drugs are contraindicated,” said Heartbeat International General Counsel Danielle White. “In doing so, it ignored the devastating risks of the chemical abortion drugs falling into the hands of bad actors, who could take the life of a woman’s unborn child through coercion, force, or deception, leaving her with a lifetime of emotional trauma.”

The Fifth Circuit’s August 2023 ruling had prohibited abortion providers from sending chemical abortion drugs through the mail, which the FDA had been permitting since 2021 in violation of longtime federal law.

The Fifth Circuit had also held that the FDA’s 2016 action of extending the allowable gestational age for taking chemical abortion drugs, removing two of the three required doctor’s office visits, allowing non-doctors to prescribe the chemical abortion drug regimen, and eliminating the requirement that providers report non-fatal adverse events to the FDA Adverse Event Reporting System violated the Administrative Procedure Act, and upheld the district court’s decision reinstating the original 2000 safeguards.

Attorneys for Alliance Defending Freedom (ADF) filed a brief with the Supreme Court Feb. 22, also asking it to hold the FDA accountable for unlawfully removing the safeguards for mifepristone. ADF is representing the Alliance for Hippocratic Medicine in the case, and in its Feb. 22, brief had asked the Court to affirm the Fifth Circuit’s decision as well.

Heartbeat argued in its Feb. 29 brief that the FDA’s allowing for dispensing via mail violates the Comstock Act, which bans interstate mailing and shipping of abortion-inducing drugs, and this, coupled with removing the in-person dispensing requirement override protections that many states have put in place to protect unborn lives. These state protections were recognized as valid even under Roe v. Wade and Planned Parenthood v. Casey, Heartbeat said in its brief. And further, the FDA’s actions also conflict with the return of the abortion issue to the people signaled by the Court’s decision in Dobbs v. Jackson Women’s Health Organization.

“The FDA does not enjoy broad discretion to remove health and safety protections on a whim. The law requires the FDA to ensure that its decisions are backed by sufficient information to show that a drug is safe for use in accordance with the proposed labeling,” White said. “The FDA removed the requirement for a woman to be seen by a medical professional less than one year after arguing in court that the very same requirement was “minimally burdensome” and “necessary” to protect a woman’s health.”

In its brief to the Supreme Court, Heartbeat argues against the FDA’s premise for its actions that pregnancy is an illness to be cured as flawed.

Heartbeat warns against women being put at risk with the use of “telehealth” to obtain a chemical abortion without ever being examined by a medical provider.

From the brief:

“The FDA’s actions … enable abortion-providers to rush a woman through the chemical abortion process, creating a risk to women of psychological and emotional injury if they later suffer abortion regret.  Moreover, these new regulations increase the risk of physical harm to women through such potential problems as the prescriber incorrectly determining the unborn child’s gestational age or failing to identify an ectopic pregnancy or other complication. Moreover, there is a documented risk for medical errors if the mother presents for post-administration treatment from an emergency department or other provider who was not involved in prescribing of mifepristone.” 

“Heartbeat is uniquely positioned to provide relevant factual background on the impact of removing certain safety safeguards for mifepristone and misoprostol,” the brief states, due to its operation of the Abortion Pill Rescue Network, a network of more than 1,400 healthcare professionals, pregnancy centers and hospitals the hotline for which answers more than 150 calls per month from women in the midst of a chemical abortion who regret their abortion decision and are seeking to carry their pregnancies to term.

Noting that the number of women receiving ultrasounds prior to beginning a chemical abortion has dropped precipitously in the time since the FDA’s relaxing of safety protocols with chemical abortion, Heartbeat said this represents a significant risk to women’s health and safety.

When Heartbeat began operating the Abortion Pill Rescue Network in 2018, nearly 100% of contacts to the Network reported having received an ultrasound prior to beginning their chemical abortion. By 2023, that percentage had plummeted to 62%.

Ultrasound is critical prior to a chemical abortion for at least three reasons, Heartbeat points out in the brief, to determine the viability of the pregnancy, to determine the gestational age of the unborn child, and to determine the placement of the pregnancy.

The result of removing the in-person visit requirement and thus ultrasound screening prior to prescribing chemical abortion drugs is an increased risk for complications, Heartbeat said.

Underscoring the risk related to the removal of the requirement to report non-fatal adverse events associated with chemical abortions, the brief states:

“From September 2000 to December 2022, 32 women’s deaths were reported as “adverse events” to the FDA, and until the FDA stopped requiring the reporting on non-fatal adverse events in 2016, documents show a total of 4,218 adverse events, including 1,049 hospitalizations (excluding deaths), 604 cases of blood loss requiring transfusions, 97 ectopic pregnancies, and 418 infections (75 of them “severe”).”

Heartbeat argues that with chemical abortion drugs more freely available than ever, there is significant risk to women’s health and safety.

In 2020, only 1% of Abortion Pill Rescue Network contacts reported receiving the chemical abortion drugs from the Internet, friends, or family. However, by 2023, that number rose to a staggering 22% of contacts to the APRN.

“The actions of the Food and Drug Administration in 2016 and 2021 lower the standard of care for women and increase the likelihood of health complications to pregnant mothers who have an abortion, despite what protections state law might otherwise have provided,” the brief states.

“The FDA’s actions give the lie to the notion that abortion was ever about healthcare or a decision between a woman and her doctor,” White said. “Now, a non-physician can prescribe chemical pills to a patient he or she has never seen who carries the burden of accurately self-diagnosing and dating her own pregnancy without any medical confirmation whatsoever.”

“This is nonsensical and careless and should not pass for “health care,” said White. “Women deserve better.”

The case is set for a hearing at the Supreme Court on March 26.

Editor’s note: Heartbeat International manages the Abortion Pill Rescue® Network (APRN) and Pregnancy Help News where this appeared. Reposted with permission.

Categories: Judicial