There’s Nothing Pro-Woman About Shoddy Standards For Abortion Pills That Can Kill Them
When it comes to distribution of the abortion drug mifepristone, the U.S. Food and Drug Administration (FDA) has been asleep at the switch. Despite comprehensive data showing higher rates of complications and emergency room visits from chemical abortion, the abortion pill has been feted by the corporate media, promoted as “safe” by President Joe Biden, and subjected to increasingly lax oversight by the FDA.
All of this makes a little-heralded recent story in Politico even more interesting. An anonymous FDA source warns against the intensifying abortion industry campaign to give abortion pills to women and girls who are not pregnant. Politico quotes the unnamed FDA spokesman expressing concern that this approach poses new health risks to women: “Mifepristone is not approved for advance provision of a medical abortion.”
The anonymous source goes on to list several safety concerns including the inability of doctors to screen for ectopic pregnancy or properly date a pregnancy (abortion pill risks increase exponentially with each week of pregnancy). To that list, we add the very real risk of sex traffickers or abusive partners using careless distribution of abortion pills to commit crimes of coercion. The Charlotte Lozier Institute has been sounding the alarm on these risks for years, though often falling on deaf federal ears.
There is little sign that the abortion industry cares about these concerns, as even the FDA has given mifepristone glancing affirmation in recent years. In fact, the FDA has been in more or less full retreat from its oversight of mifepristone.
The abortion drug regimen of mifepristone (to kill the baby) and misoprostol (to expel the dead baby) was first approved in the waning days of the Clinton administration under a regulation designed to reduce the risks associated with hazardous drugs. Known as ETASU, Elements To Assure Safe Use, the regulation was meant to ensure women obtain abortion drugs from a certified physician capable of monitoring and treating complications. For abortion pills, those complications range from death to hemorrhage to infection, requiring visits to the emergency room and, in many cases, follow-up surgery.
FDA Loosened Requirements
The initial FDA rules also required reporting and tracking these complications, which proved to be wise. Mifepristone’s original mode of administration was found to be associated with lethal infections. Other complications proved more frequent than the rate associated with surgical abortion procedures.
How did the FDA react? It changed the recommended procedure for administration, but oddly enough in March 2016, the FDA removed the requirement that only a physician could prescribe the drug and dropped any prescriber requirement for reporting non-fatal complications, the exact opposite of what one would expect the FDA would do to assure safe use. The goal was to widen distribution of the abortion pill, while learning less from its manufacturers about the dangerous complications the new policy might cause.
Use of mifepristone-misoprostol accelerated after 2016, to the point where today it is the method deployed in the majority of reported abortions. Taking advantage of the declared Covid emergency, the
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