In August of 2023, the federal district 5th Circuit appeals court ruled that the U.S. Food and Drug Administration (FDA) must restore the original safety requirements for chemical abortion drugs.
The FDA along with Danco Laboratories (a company formed to manufacture the drugs) have filed a complaint against the Alliance for Hippocratic Medicine (AHM) to reverse this ruling in the U.S. Supreme Court.
The government agency established to protect the public health by assuring the safety, efficacy and security of the supply of drugs, medical devices and the nation’s food supply is fighting in court to not protect female patients.
Who is the FDA actually protecting?
Make it make sense.
In 2000 the FDA approved the use of mifepristone for chemical abortions with protocols. These critical safety requirements were removed by the FDA in 2016 without reasonable explanation, and in 2021 the FDA allowed the drug to be given without an initial in-person visit to confirm pregnancy and rule out possible related complications.
Now in an effort to provide some protection for those women who could be harmed by chemical abortion, Alliance Defending Freedom (ADF), which is representing AHM, a group of pro-life doctors and organizations, has filed a brief with the Supreme Court in the case.
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Consider if the FAA, which is charged with regulating air travel, as well as developing and administering protocols for aircraft safety, suddenly changed standards and curbed pilots’ pre-flight checks to save time. Would this be acceptable?
Before takeoff pilots check all their instruments to determine if everything is operational for lifting off, flight, and landing. If standards were lowered and the pilot only needed to determine that the plane can sufficiently takeoff and this enabled airports to get more planes out of the terminals faster, obviously the sacrifice of safety would not be tolerated.
The FDA’s removal of safety protocols, placing the burden of treating women harmed by the lax administration of the abortion pill on emergency-room doctors and other on-call medical professionals is analogous to the FAA lowering standards and expecting emergency responders to deal with the potentially tragic results at airports.
This is intentional, as ADF noted in its brief to the Supreme Court, “That OB/GYNs, OB/GYN hospitalists, and emergency-room physicians will often be called upon to treat abortion-drug complications is not a bug in the FDA’s abortion-drug plan but part of its very design.”
“Women should have the ongoing care of a doctor when taking high-risk drugs,” ADF Senior Counsel Erin Hawley said.
“The FDA’s own label for abortion drugs says that roughly one in 25 women who take them will end up in the emergency room,” said Hawley. “But the FDA recklessly removed essential safeguards like the ongoing care of a doctor leaving women to suffer serious complications all alone.”
Tweet This: “Women should have the ongoing care of a doctor when taking high-risk drugs” - ADF Senior Counsel Erin Hawley
Exodus 21:22-23 established law regarding pregnant women where mother and child were to be protected. If a woman were harmed, even accidentally, causing a premature birth there would be a penalty and should the result be death of the mother and/or the child, the perpetrator would be put to death.
Matthew Henry, a 17th century preacher and author of Biblical commentary stated, “The law of nature obliges us to be very tender in that case, lest the tree and fruit be destroyed together. Women with child, who are thus taken under the special protection of the law of God.”
For over a half-century, our nation, which was established with laws protecting a woman with child, has abandoned this Biblical principle.
ADF attorneys are asking the Supreme Court to affirm the decision of the 5th Circuit which found the FDA acted unlawfully by removing its original safety standards. This includes doctor’s visits to check for ectopic pregnancies, severe bleeding, and life-threatening complications, as well as reporting requirements - so women are better informed about the serious risks associated with chemical abortion drugs.
“No agency is above the law,” ADF said in its brief. “Congress gave federal courts the authority and obligation—to review the actions of agencies that regulate nearly ‘every nook and cranny of daily life.’ FDA’s insistence that (the Supreme) Court cannot check its work runs counter to the Administrative Procedure Act.”
The FDA’s record of relaxing of standards is well documented, along with current black box warnings, and medication guide through which the FDA has advised the drug can cause serious and sometimes fatal infections and bleeding.
Also documented are the potential conflicts of interest and dubious funding trail from investors in abortion pill manufacturers Danco Laboratories and GenBioPro, dollars from which have been funneled to different groups behind clinical trials and studies of the abortion pill - which claim it is both safe and effective.
The Administrative Procedure Act was enacted to ensure a process was in place so that the standards of the FDA and other oversight government organizations would provide accountability in their practices. The Supreme Court will decide in AHM v. FDA case whether the FDA violated the Act.
What has unfolded is what the AHM has called a “textbook violation of the Administrative Procedure Act.”
The FDA also regulates food. Its careless actions in the case of regulating the abortion pill would compare to the agency ignoring an outbreak of salmonella. It would be unacceptable for them to leave such an event unchecked just hoping emergency responders would keep up.
AHM is speaking out on behalf of the real victims of the FDA’s negligence because, as noted in the brief, patients themselves are hindered from bringing their own lawsuit. Due to privacy issues and simply being unaware of the effect of the FDA’s regulatory actions, few would know or understand the correlation of FDA standards and their own injuries.
A hearing in the case is scheduled for March 26, with a pro-life rally set to that morning on the steps of the Supreme Court. Prayer is in order, for our government agencies to return to serving the people and respecting life.
Editor's note: Heartbeat International, which has also filed a brief in FDA v. AHM, manages Pregnancy Help News.
