The Following Content Has Been Provided by:Bob Unruh
Fifty-one senators making up a majority of the U.S. Senate have written to the U.S. Food and Drug Administration asking for officials to suspend approval of a generic abortion drug, like mifepristone, following the bureaucrats’ recent expansion of the use of that abortion drug.
It’s because the FDA previously pledged to conduct a thorough review of the safety of the drug used to kill unborn children.
The letter went to Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary.
The letter said the senators “recognize the FDA’s statutory responsibility in evaluating drug applications,” but challenged that “the timing of this approval appears inconsistent with the comprehensive safety reassessment your agencies have prioritized.”
“Out of respect for this important review, and with full confidence in your dedication to protecting women’s health, states’ rights, and unborn life, we urge you to take decisive action to reevaluate whether this generic version of mifepristone is suitable to enter the market,” the senators said. “Today, your agencies have all the information they need to bring an end to previous Democrat administrations’ abortion drug regulations while a comprehensive review is conducted.”
The senators recommended:
- Suspend the approval of any new generic versions of mifepristone pending the outcome of the REMS safety review;
- Commit to ensuring that all generic versions of mifepristone are included in the ongoing reevaluation of prior REMS approvals;
- Reinstate the in-person dispensing requirement for mifepristone and all its generic versions;
- Suspend the distribution of mifepristone and all generic versions as an “imminent hazard” under Section 505(e) of the Federal Food, Drug, and Cosmetic Act (FDCA); and
- Withdraw FDA guidance permitting pharmacy distribution of mifepristone and all its generic versions.
The senators explained, “We are committed to continuing to work together to give a voice to the voiceless and protect women from the dangerous effects of unregulated access to chemical abortion drugs. The life, safety, freedom, and health of millions of Americans, born and unborn, depend on it.”
They warned, “The ‘abortion-on-demand’ culture enabled by the Biden-Harris administration’s removal of critical safeguards on the only FDA-approved abortion regimen is currently the biggest threat to unborn life in America today. Under current FDA regulations, these drugs can be obtained via mail order without meaningful consultation with a medical professional and without any confirmation of who is purchasing them or for what purpose.”
The threat? “These policies have enabled abortion pills to be obtained by abusers, traffickers, and even minors. The aftermath has not only been deadly for preborn babies, but lethal to their mothers. Contrary to the narrative peddled by the media that taking abortion pills is ‘safer than taking Tylenol,’ evidence shows that the risk of serious medical complications after taking mifepristone is at least twenty-two times higher than reported on the drug label.”
They said, “In fact, more than 1 in 10 women who take mifepristone will experience a serious adverse event.”
They want to see the government going another direction than when “The Biden-Harris administration enabled the deception of American women and the violation of states’ constitutional rights by relying on faulty data to claim that there would be no increase in complications if abortion drugs were approved for mail-order.”
In 2000, when the FDA first addressed the use of mifepristone, numerous restrictions were put on the drug’s prescription and use. Then Barack Obama eliminated the requirement that the abortion drug be prescribed by a physician and consumed in-office, as well as the mandatory follow-up visit and reporting of complications.
Then Joe Biden pushed the pro-abortion ideology further, doing away with almost all of the remaining safeguards.
Sens. Lisa Murkowski. R-Alaska, and Susan Collins, R-Maine, were the only Republicans to refuse to cooperate.
