WASHINGTON, D.C. (LifeSiteNews) — Senator Josh Hawley (R-MO) expressed his “grave concern” and demanded answers from the Food and Drug Administration (FDA) on its decision to approve a generic abortion drug despite significant safety concerns.
Last week, the FDA, led by Commissioner Marty Makary, gave its “surprise approval,” according to Sen. Hawley, of “a new generic abortion drug.” The approval came despite a recent announcement that the FDA planned to study the safety of the abortion pill.
Hawley had previously expressed skepticism of Makary’s nomination but had voted to confirm him partially due to his promise to investigate the safety of abortion drugs. Although the drugs can never truly be safe because they aim to kill an innocent preborn baby, they can also be incredibly damaging for women, as Hawley pointed out in his October 3 letter.
“As you know, recent data shows that nearly 11% of women who use the chemical abortion drug, mifepristone, experience a serious adverse health event—like sepsis or hemorrhaging—within 45 days,” Hawley stated. “That is an adverse-event rate at least 22 times greater than currently disclosed on the FDA-approved drug label.”
He noted Makary had promised a “thorough safety review of mifepristone and existing regulations,” yet the latest decision undermines that promise.
He wrote:
The timing of your agency’s approval raises further questions. FDA is supposed to be conducting a review of the safety regulations around mifepristone. But because this new generic has been approved before any changes to those safety protocols, this drug may be exempted from any new safety standards imposed on mifepristone in the future. That would render your safety review toothless and irrelevant.
Sen. Hawley asked Makary what his involvement was in the decision to approve, whether the review included an evaluation of “adverse events,” and if the drug would be allowed to stay on the market regardless of the current inquiry launched by the FDA.
Soon after approval of the drugs, Hawley accused Makary of “betrayal,” according to the Washington Examiner.
HHS claims it had to approve new drug, but Washington Post says that’s not true
The Department of Health and Human Services (HHS) defended the decision to approve another dangerous drug to kill innocent preborn babies by saying it is required to approve drugs if they are similar to other pills.
HHS Secretary Robert F. Kennedy Jr. responded to the criticism last week and said “federal law requires approval when an application proves the generic is identical to the brand-name drug” and insisted that the FDA’s review was still ongoing.
“The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap,” he said. “Recent studies already point to serious risks when mifepristone is used without proper medical oversight.”
Even the liberal Washington Post challenged this claim from the HHS.
“But the FDA has the ability to slow approvals of generic drugs, such as requesting more data from manufacturers. The agency took 10 years to approve the first generic version of mifepristone, made by GenBioPro,” the Washington Post reported. “A similar outcry arose among abortion foes when the first Trump administration approved that medication in 2019.”
Evita Solutions is the creator of the drug. Its explicit goal is to make it as easy as possible for women to kill their innocent preborn babies.
Evita’s stated mission is to “normalize abortion” and make it “accessible to all,” as LifeSiteNews previously reported.
Hawley has been a vocal critic of the HHS and FDA’s failure to address the abortion drug crisis.
Soon after news broke of approval, Hawley said “This is shocking. FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother.”
“And of course 100% lethal to the child.”
Pro-life groups also criticized the decision.
“The Trump Administration’s approval of a new and deadly generic version of Mifepristone, without doing anything to protect mothers from abusers, women from reckless distribution leading to injury, infertility, and even death, or the environment from abortion water pollution represents a true failure,” Kristan Hawkins, president of Students for Life Action, stated in a news release.
