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| Sen. Cindy Hyde-Smith (R-MS) |
Mifepristone is the first part of the two-pill chemical abortion regimen. It starves and asphyxiated an unborn child by blocking the pregnancy hormone progesterone, which facilitates the transfer of oxygen and nutrients to the child. This year, the Biden administration had the FDA "temporarily" stop enforcing REMS regulations governing the distribution of mifepristone for the remaining duration of the pandemic. Since then, the administration predictably announced that it is considering whether it will end those regulations altogether.
Sen. Hyde-Smith questioned Dr. Janet Woodcock, the acting commissioner of the FDA, during a Senate Agriculture Appropriations Subcommittee hearing to voice her concerns about this potential change in FDA policy.
“The FDA decision is alarming because this drug is dangerous. The limited data we do have shows unacceptable rates of complications for women and girls,” Hyde-Smith said.
“I am particularly struck by the inconsistency of FDA’s actions. For instance, the FDA and CDC imposed a pause on the Johnson and Johnson COVID vaccine after reports of blood clots in some women. At the same time, FDA is expanding the approval for chemical abortion pills that have much, much higher risks of blood clots than the J&J vaccine,” she said.
Hyde-Smith also pointed out that 20% of reported complications from mifepristone were life-threatening or resulted in death.
Hyde-Smith asked Woodcock to "mandate the collection of complete and accurate information of all adverse events related to this drug... so that the FDA has complete and accurate data for its review for this abortion pill."
In response, Woodcock grinned and gave a snide remark: “I will have to look at the conditions of the REMS. All serious events need to be reported to the FDA. So let me look into that, but it may well be that if a person has a headache after using this drug that that may not have to be reported because it’s a non-serious, self-limited event.”
