WASHINGTON, D.C. (LifeSiteNews) – A former official with the U.S. Food & Drug Administration (FDA) is speaking out against the Biden administration’s “dangerous” moves to promote abortion-inducing drugs for reasons that have nothing to do with medical evidence and everything to do with political ideology.
Since Roe v. Wade was overturned last summer, allowing states to directly ban abortion and reactivating numerous old abortion laws, the abortion lobby and its Democrat allies have been scrambling to enact a number of strategies to preserve abortion “access” across state lines.
Among those moves was the FDA eliminating the requirement that abortion pills only be dispensed in-person to the women taking them, and the Biden Justice Department’s Office of Legal Counsel (OLC) declaring that abortion pills may be freely mailed across the country, despite the fact that a provision of a 150-year-old law called the Comstock Act expressly says the opposite.
On February 28, Fox News published an op-ed by David Gortler, a former FDA medical officer/analyst and drug, device and vaccine safety expert, who is now with the Ethics & Public Policy Center (EPPC). He notes that when the agency originally assessed mifepristone (Mifeprex) in 2000, it concluded that it “may be administered only in a clinic, medical office, or hospital, by or under the supervision of a physician, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies.”
“In fact, mifepristone is so unsafe that it could only be dispensed under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) protocol since 2011,” he continues. “REMS protocols are only issued to high-risk drugs which means that mifepristone is one of the rarely selected FDA-approved drugs that although approved, has unusual ‘serious safety concerns.’”
Yet Biden’s decisions were not based on “unearth[ing] data showing that mifepristone is safer than originally thought,” but rather “small, non-safety-focused studies” with pro-abortion authors and sponsors “from places like The National Abortion Federation and the biased UCSF Bixby Center for Global Reproductive Health.”
“Indeed, studies referenced were shamefully deceptive, and instead of referencing ‘safety’ used muddy, academically unacceptable language like ‘unplanned clinical encounters,’” Gortler writes. “The few studies the FDA relied on for its safety determination were not prospectively, longitudinally, statistically or appropriately designed safety-centric studies despite mifepristone currently being a REMS product.”
“Further, studies that did reference safety used in-house monitoring and ultrasounds to confirm age of the fetus and evaluate bleeding — which are now omitted,” he goes on. “Importantly, the one study the FDA referenced with a noteworthy number of participants required in-patient visits and still concluded increased hospital visits.”
“The FDA deceivingly states in its review ‘there have been no new safety concerns identified,’” he notes, “but ignores existing ones and contemptibly omits multiple, large specially designed safety studies with obviously negative findings published during the same 2019-2021 time period!”
READ: Study finds 6 in 10 women who had chemical abortions wanted help or emotional support after
A 2020 open letter from a coalition of pro-life groups to then-FDA Commissioner Stephen Hahn noted that the FDA’s own adverse reporting system says the “abortion pill has resulted in over 4,000 reported adverse events since 2000, including 24 maternal deaths. Adverse events are notoriously underreported to the FDA, and as of 2016, the FDA only requires abortion pill manufacturers to report maternal deaths.”
A recent letter by 19 state attorneys general notes that even the left-wing American College of Obstetrics & Gynecologists (ACOG) has found that chemical abortions are almost six times as likely to result in medical complications as first-trimester aspiration abortions.
“Mailing abortion pills seems to be a thinly disguised partisan response by the White House that deliberately ignores comprehensive safety findings, and just another radical pro-abortion response by the Biden administration to the Supreme Court’s Dobbs decision,” Gortler concludes. “Today’s FDA has become a marionette performing for the Biden White House and Big Pharma. This new and concerning trend shows no signs of stopping. In the meantime, the cumulative safety profile of mifepristone predicts that the FDA’s decision to allow mailing of abortion drugs for at-home use will lead to preventable morbidity and mortality in America’s women and children.”
Pro-lifers argue that with the Biden administration completely eliminating requirements that abortion pills be taken under any medical supervision or with medical support close by, those events are certain to increase.
Yet the White House and the abortion lobby have determined that, with the overturn of Roe restoring states’ ability to decide their own abortion laws, easy distribution of abortion pills will be one of their chief methods of preserving abortion “access.” In November 2022, Operation Rescue reported that a net decrease of 36 abortion facilities in 2022 has led to the lowest number in almost 50 years, but the chemical abortion business has “surged,” with 64 percent of new facilities built last year specializing in dispensing mifepristone and misoprostol.