The latest hearing in the Alliance for Hippocratic Medicine v. FDA (the FDA abortion pill case) proved to be the fiercest yet. Arguments were heard at the 5th Circuit Court of Appeals over the FDA’s alleged failure to safeguard women and girls against the abortion pill, mifepristone. What was assumed would be a rehashing of facts already heard in court in March turned out to be a sharp exchange between judges and lawyers of all parties. This hearing brought out striking information on modern-day abortions that would shock most Americans. Let’s dive in.
Where’s the Doctor?
Whenever the topic of abortion is brought up, pro-abortion activists turn to the knee-jerk slogan, “Politicians should stay out of a decision between a woman and her doctor.” They repeat this slogan ad nauseam as it proves to be one of their most effective talking points with the public. I’m curious if any of them watched this hearing because there’s a problem…when it comes to the most used form of abortion, the doctor is gone. Biden’s FDA has completely taken the doctor out of the process. The 5th Circuit judges asked FDA counsel if the most widely used form of abortion requires a doctor.
She answered, “No doctor has to be involved. That’s true.”
She’s right. During the COVID-19 pandemic, the Biden Administration removed the requirement of in-person medical visits and made it permanent in Dec. 2021. This decision stripped ultrasounds, labs and in-person screening with a doctor or medical staff. The FDA’s lawyer claimed that ultrasounds are more formality than safety – used only as a data gathering tool. This is a dangerous mindset when it comes to women with ectopic pregnancies. One in 50 women have ectopic pregnancies and must be confirmed by an ultrasound. Without it, women taking abortion pills face life-threatening ruptures requiring immediate surgery. It is also true that without medical staff you can’t confirm how far along the woman is in her pregnancy, which is critical because mifepristone is not to be taken past 10 weeks. But according to FDA counsel, the 10-week gestational limit isn’t tied to patient safety. When pressed by the judge how to gauge gestational age, counsel replied, “You can assess by asking questions.” With abortions now being mailed and self-managed, if an abortion is between a woman and her doctor – where is the doctor?
Abortions by email?
What started as a conversation about telehealth abortions quickly turned into a grill on how telehealth is conducted. One judge asked how telehealth in the case of the abortion pill works: “Is it video, Zoom so they observe the person to see what the gestational stage is? Can this be done via email…all just an email exchange, is that all that’s required?”
To which the FDA counsel replied, “FDA does not dictate the practice of medicine.” The judge asked if the medical staff conducting telehealth for abortions are required to be in the same state as the woman because they’ve seen amicus briefs citing that people are using intermediary addresses and drop boxes to ship pills to different states. To which FDA counsel answered again that none of those issues are dictated by the FDA. Another judge jumped in to ask, “Did the FDA consider crossing state lines, telemedicine across state lines, or intermediaries…the idea that someone in California would prescribe things for someone in Mississippi and that there would be go-arounds, work-arounds?” FDA counsel responded swiftly, “No, those things are not relevant [to the safety of the drug] and no reason to think that’s part of the problem.”
But it is a problem for myriad reasons.
Abortions by email, telehealth or transport can’t safeguard women and girls against coercion or abuse. These situations can’t account for abusers who may be just out of view of the computer screen or peddling abortion pills. It’s reckless to think that an intermediary address and the transporting of pills will result in the same environment as an in-person visit.
The “FDA can do no wrong.”
The plaintiffs in the case, a group of doctors led by the Alliance for Hippocratic Medicine (AHM), point out that the FDA ignored their own policies again and again – first when they fast-tracked approval of the abortion pill by designating pregnancy as an “illness,” second when they failed to conduct any focused studies on minors, third when they used COVID-19 as a reason to do away with medical visits, ultrasounds and lab work. They just started letting pills be shipped straight to people’s homes (sometimes without parental notification or consent).
When the judges asked FDA’s counsel about this, she replied that it is not the court’s role to second guess the FDA’s expertise and this case needs to be resolved strictly on procedural grounds. Judge Ho shot back, “Why not just focus on the facts of this case rather than have this sort of ‘FDA can do no wrong’ theme?” and sharing they had just heard an FDA case the day before. It’s not just the judges who are skeptical of the FDA’s expertise; a majority of Americans say they don’t trust the FDA. Because it’s not the first time the FDA has been too cozy with drug makers – just look at the many opioid scandals. The idea that agency decisions are set in stone and no one can ever question them is not just inaccurate but undemocratic, and in the case of mail-order abortion pills it’s downright dangerous. Both sides of the aisle have challenged FDA decisions. It was a Democrat governor who sued to block Zohydro (an opioid) in Massachusetts due to concerns about abuse. The FDA left it on the market for almost a decade before it was finally pulled for not being safe.
After listening to this full exchange, one thing is clear - not one judge held back in their pursuit of the truth.
Emily V. Osment is vice president of communications for Susan B. Anthony Pro-Life America.
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