FDA used flawed studies, bad data to allow abortion pills by mail: report – LifeSite

(LifeSiteNews) – The U.S. Food & Drug Administration (FDA) resorted to selective data and misleading claims to justify lifting the requirement that abortion pills be administered in person, according to a paper published May 11 in the journal Issues in Law & Medicine.

In December 2021, the FDA under the Biden administration cleared the way for pharmacists to send abortion pills through the mail as long as the recipient has a prescription. Alliance Defending Freedom sued on behalf of pro-life doctors and activists, and U.S. Supreme Court is currently weighing whether to uphold or strike down the change.

As highlighted by the pro-life Charlotte Lozier Institute, the paper (of which Lozier Vice President and Director of Medical Affairs Ingrid Skop is one of the co-authors) details a series of serious issues with the methodology by which the FDA determined remote distribution of abortion pills would be safe.

Among them, the FDA claimed to have only received a small number of adverse event reports related to abortion drugs in 2020 when in fact abortion drug prescribers have not been required to report non-lethal complications since 2016, meaning the agency was relying on a pool guaranteed to be hobbled by under-reporting.

“In a letter to the leaders of the American College of Obstetricians & Gynecologists (ACOG) and Society of Maternal-Fetal Medicine (SMFM), Dr. (Janet) Woodcock (then acting FDA commissioner) identified four studies that the FDA reviewed to justify its decision to remove the in-person prescribing requirements,” the paper said. “Most were small and incomplete (with follow-up data not available on all women) and did not replicate the conditions of use that the FDA approved (because they all included at least some women who received routine pre-abortion testing).”

“U.S. studies are often of poor quality because most abortions are paid for privately and women are often hesitant to report a preceding abortion if they have a complication, due to shame, or in some cases because they have been advised by the abortion provider or encouraged by abortion advocacy groups to omit this information, allowing emergency physicians to assume that a miscarriage instead of an abortion led to the complication,” it adds. “Additionally, many studies are plagued by large numbers of women lost to follow-up, for whom abortion outcomes are unknown. In the U.S., there are no federal mandatory complication reporting requirements or accurate centralized systems collecting data related to abortion — leading to substantial uncertainty of the numbers, complications and deaths following abortion.”

“When higher quality, more robust data is considered in the U.K., examining all available ICD-10 codes that reference complications, and defining a failed abortion resulting in retained pregnancy tissue as a complication, it appears there were at least five to ten times as many complications in reality as initially reported — and likely many more,” the authors warned. “When examined thoroughly, the United Kingdom data shows that medical abortion with mifepristone and misoprostol has significantly higher complication rates than the Aiken, et al. study referenced by the FDA suggests, especially when these pills are distributed without standard pre-abortion testing and without medical supervision, AKA ‘pills by post.’”

Skop and another of her co-authors, Oxford’s Dr. Calum Miller, said that the FDA “must follow the science by considering the highest quality studies examining the safety of abortion drugs, and they must follow the laws regulating their actions,” but has “done neither in their approval and subsequent loosening of safeguards surrounding mifepristone and misoprostol abortions. The FDA must protect the health and safety of women and girls by reinstating critical safeguards and be held accountable to the American people.”

Easy access to and interstate distribution of abortion pills is one of the abortion lobby’s most potent tools for perpetuating abortion-on-demand post-Roe v. Wade, which they are aggressively pursuing regardless of the risks to the women they are supposedly serving.

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.”

Pro-lifers warn that with the Biden administration completely eliminating requirements that abortion pills be taken in the presence of a medical professional, meaning without any medical supervision or medical support close by, those events are certain to increase. 

“A November 2021 study by Charlotte Lozier Institute scholars appeared in the peer-reviewed journal Health Services Research and Managerial Epidemiology,” Catholic University of America research associate Michael New wrote. “They analyzed state Medicaid data of over 400,000 abortions from 17 states that fund elective abortions through their Medicaid programs. They found that the rate of abortion-pill-related emergency-room visits increased over 500 percent from 2002 through 2015. The rate of emergency-room visits for surgical abortions also increased during the same time period, but by a much smaller margin.’”

In November 2022, Operation Rescue reported that a net decrease of 36 abortion facilities in 2022 led to the lowest number in almost 50 years, yet the chemical abortion business “surged” with 64 percent of new facilities built last year specializing in dispensing mifepristone and misoprostol. Citing data from the pro-abortion Guttmacher Institute, STAT says mifepristone “accounts for roughly half of all abortions in the U.S.”

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