In mid-March, the COVID scrambling began.
Facing an unprecedented threat from a novel virus, many parts of the country experienced some degree of lockdown. And lockdowns required priorities.
Services were put to the litmus test: Is this essential? Their value was determined against the backdrop of fear of exposure to the virus. Suddenly, people were considered safer the less they left their homes.
Minnesota-based Dr. Julie Amaon had just completed her family medical residency as Americans were confronted with the new pandemic. With fears of COVID exposure running high, resulting COVID-restrictions “presented an opportunity to try something new.”
This new opportunity? “No-touch” abortion.
Amaon, medical director of Just the Pill, a non-profit clinic in Minnesota, began mailing medications for abortion in September of this year.
Just the Pill’s Instagram account succinctly markets the services: “Medication Abortion By Mail in Minnesota. Get services by mail in the comfort of your home! No office visit – Abortion online.”
Minnesotans can now go online, electronically sign forms, answer some questions, consult by phone with a doctor, and have their abortion packages delivered straight to their mailboxes. All without ever leaving their homes.
To be clear, the drive to offer telemedicine chemical abortions, also called medical abortions, in the U.S. was already in motion prior to the pandemic – in the form of a pilot study being conducted in participating states. This study is currently assessing the “feasibility” of telemedicine consults partnered with accompanying mail-delivered abortion medications.
Still in research-mode, this study is to be completed in 2022.
Then two things happened to fast-track this “research” option: a pandemic and a lawsuit.
In May 2020, with COVID in full swing, the American College of Obstetricians and Gynecologists issued a complaint against the U.S. Food and Drug Administration (FDA) asking a federal court to remove certain restrictions on Mifeprex “in the current COVID-19 pandemic.” Mifeprex, taken in combination with another medication, Misoprostol, induces an abortion in early pregnancy.
The restrictions in question are intentionally in place under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) “to mitigate the risk of serious complications associated with mifepristone,” which is the generic version of Mifeprex. The FDA requires these strategies for “certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.”
Mifeprex is one of these medications.
As part of the REMS protocol, the FDA requires that Mifeprex “only be dispensed in clinics, medical offices, and hospitals.”
This protective guideline, put in place by the FDA – the governmental agency tasked with the mission of “protecting the public health by ensuring the safety, efficacy, and security” of medications - was overturned by the decision of one federal judge.
Just the Pill’s consent form indicates their “no-touch” medication abortions are performed without any preliminary lab work or ultrasounds and admits that this delivery system brings “additional risks.”
Specifically, the consent form notes that “foregoing pre-medication ultrasound” means the Just the Pill doctor cannot know for certain that a woman doesn’t have an ectopic pregnancy which, “if untreated, can develop into a life-threatening emergency.”
Additionally noted, by bypassing an ultrasound, the Just the Pill doctor cannot know whether the woman has dated her pregnancy accurately (“affecting the success, side effects, and complication rate”) or even if the woman is experiencing an undetected miscarriage.
Guidelines by the U.S. manufacturer of Mifeprex, Danco, state explicitly that some women should not take Mifeprex – among those are women who have an ectopic pregnancy and women who have a pregnancy that is more than 70 days old.
Without an ultrasound, the conditions required by the manufacturer cannot be guaranteed.
While Just the Pill notes these concerns, they put the dangers that come with these uncertainties on the woman. She signs a waiver acknowledging she is willing to assume the risks inherent in bypassing these medically protective and informative services.
Tweet This: Without an ultrasound, medically protective & informative services prior to chemical abortion are bypassed - and the risk put on the woman
In response to the judge’s removal of this FDA requirement, 29 conservative and pro-life leaders sent a letter to the FDA stating that abortion advocates are “using the coronavirus pandemic as a ruse.”
The authors of the letter assert that “this rogue judicial activism is a gross breach of the separation of powers, undermining the FDA’s statutory authority to regulate drug safety, while recklessly endangering American women and preborn children.”
They further implore the FDA to “fight back against the abortion industry’s radical push to overturn REMS in the courts.” These leaders are clear in their charge that this overturn is rooted in an effort to remove the REMS protections, with the pandemic simply providing the opportunity to do so.
Amaon offers no pretense regarding her aim to make this method the new normal, stating she “doesn’t see why digital access to abortion medication should be rolled back at all.” She further questions - “Why can’t we keep doing this?”
She is not alone. Others, as voiced in lifestyle and news publications, are also questioning the possibility of striking down these safeguards permanently and making COVID-related changes the new model for providing chemical abortions.
FDA guidelines, though, have already addressed these questions by placing the drug under REMS protocols. Why? Because the drug is dangerous. Because this drug – Mifeprex – has serious safety concerns. Because the FDA is not charged with simply making things quick and easy. They are charged with keeping us safe.
The pandemic does not erase that charge.
Editor's note: Heartbeat International manages the Abortion Pill Rescue Network and Pregnancy Help News.