The US Supreme Court has announced that it will hear an appeal by the FDA in the case of Alliance for Hippocratic Medicine [AHM] (et.al.) v. FDA (et.al.) in which AHM alleges (essentially) that the FDA has violated its fiduciary responsibility to the public and its own policies by approving the abortion pills (mifepristone and misoprostol) without adequate investigation of the safety of the drugs, and that the FDA “acted unlawfully in removing common-sense safeguards for women by authorizing dangerous mail-order abortions.”

The issues being alleged are (1) that the drugs are unsafe and can cause injury and death to the women using them, and (2) that it is unlawful for the FDA to remove the “common sense safeguards” of requiring a health care provider to examine the patient and give proper advice concerning the risks of using the drugs before they are provided by prescription.

The Alliance for Hippocratic Medicine cites its mission: “The Alliance for Hippocratic Medicine (AHM) upholds and promotes the fundamental principles of Hippocratic medicine. These principles include protecting the vulnerable at the beginning and end of life, seeking the ultimate good for the patient with compassion and moral integrity, and providing healthcare with the highest standards of excellence based on medical science.” Joining AHM in its action is George Delgado, MD, who pioneered the abortion pill reversal procedure. [He will be speaking at https://lifefirst.org/2024-dinner-for-life/ on April 20]

The original case was filed in November 22, 2022, and made its way to the federal 5th Circuit Court of Appeals, which ruled in August 2023 that the FDA “failed to address several important concerns about whether the drug would be safe for the women who use it.”

The court further said that the FDA failed “to consider the cumulative effect of removing several important safeguards” and “to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”

About 60% of abortions in the United States are now done by these drugs and that number is expected to rise to 80%. That makes this case regarding safety of the pills and access to the pills by tele-medicine rival the importance of the Dobbs case in which Roe v Wade was overturned.

In February 2022, Judicial Watch decided to investigate whether the FDA had acted properly in approving the abortion pills, and especially whether there is a safely issue that has been properly addressed. The US Department of Health and Human Services (HHS) refused three requests for the records until forced to release 588 pages after being sued under the Freedom of Information Act. These records included an “Annual Report for Mifepristone” covering September 28, 2000 to September 27, 2021.

Of the 32 reported adverse events, one was “hemorrhage due to a ruptured ectopic pregnancy that resulted in death.” About 2% of pregnancies are ectopic (not inside the uterus). Whereas ectopic pregnancies occur randomly, there are risk factors that greatly increase the risk for ectopic pregnancies. If a woman was seen by a health care provider and properly assessed, an ultrasound would be indicated to verify the dates of the pregnancy and that the pregnancy was in the uterus before the pills were prescribed.

Another reported adverse event was “post abortal (sic) parametritis/endometritis, adult respiratory distress syndrome and bilateral pneumonia.” These are extremely serious life-endangering complications, although it appears that this woman survived.

In other studies that Judicial Watch reviewed, one woman had a fatal Clostridium sordelli infection, another needed blood transfusions, and another was hospitalized and died.

In 2002, Danco labs (which produces the drugs) wrote a “Dear Health Care Provider” letter acknowledging reports of ruptured ectopic pregnancies and one death. The letter advises that ectopic pregnancy “should be ruled out before initiating Mifeprex treatment (sic).” The letter also acknowledged two serious systemic bacteria infections (sepsis) and that one woman died. Another woman age 21 died of a heart attack 3 days after taking Mifeprex and misoprostol. Judicial Watch also reported on a safety study by Exelgyn Laboratory in which several cases of excessive bleeding and sepsis were reported, including one death.

The 5th Circuit Court of Appeals reviewed all of this data when making its findings. Despite serious concerns about the safety of these drugs, and despite compelling evidence that they should not be prescribed without proper assessment by a health care professional in person with full disclosure of the risks, the Biden administration has appealed the finding to the justices of the Supreme Court.

If it were not for a pattern of behavior in so many other areas where the safety of the public seems secondary to a political agenda, it would be hard to believe such callous irresponsibility. It is also hard to imagine women’s groups that support abortion advocating the pills without proper evaluation of the woman and accurate medical advice concerning the risks. In view of the evidence available to the justices, let us hope and pray that common sense will prevail.

It is ironic that we who advocate for women to consider every possible alternative before resorting to abortion should be the ones who are advocating for the safety (as much as possible) of women who make the decision to use the pills. Those who advocate for abortion are also the ones who would accept the suffering and possible death of young women without proper advice and a discussion of the risks before they decide to use the abortion pills. Ironic.