March 12, 2019 (LifeSiteNews) – The U.S. Food and Drug Administration (FDA) on Tuesday released two letters it sent last Friday to a pair of websites offering unapproved versions of the abortion-inducing drugs mifepristone and misoprostol.
The letters to Aidaccess.org and Rablon note that the sites sell mifepristone and misoprostol tablets in “packs” that can be acquired without a prescription and taken without a medical professional’s guidance or supervision. In “normal” chemical abortions, abortionists give women the first pill (mifepristone, or RU-486) in an office, then have them take the second (misoprostol) at home.
By contrast, these sites each offer a product that “contains prescription drugs intended for a condition that is not amenable to self-diagnosis and treatment by a layperson,” the letters warn, so “adequate directions cannot be written such that a layperson can use the product safely for its intended use.” In addition, they lack “adequate warnings against use…where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application.”
Even the FDA-approved prescription version of mifepristone, Mifeprex, “bears a boxed warning indicating that the drug carries a risk of serious or even life-threatening adverse effects, including serious and sometimes fatal infections and prolonged heavy bleeding,” and is therefore “only available in the U.S. through a Risk Evaluation and Mitigation Strategy (REMS) program” and obtainable only from REMS-certified healthcare providers.
The REMS requirements ensure that providers can “assess the duration of the pregnancy accurately, diagnose ectopic pregnancies, and provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made arrangements for others to provide such care”; give women “access to medical facilities for emergency care”; and more – none of which applies to Aidaccess.org’s “Combipack” or Rablon’s “Abortion Pill Pack.”
“By facilitating the sale of the unapproved and misbranded” products, the FDA says, these sites are “causing important safety measures that are put in place for FDA-approved mifepristone for medical termination of early pregnancy to be bypassed.”
The letters put them on notice to “promptly cease causing the sale of unapproved new drugs and misbranded drugs to U.S. consumers and correct all other violations of the FD&C Act,” or else face regulatory action potentially “including seizure or injunction, without further notice.” The websites have 15 days to confirm their compliance.
The left-wing Vox notes that abortion supporters “have long viewed REMS as a ‘medically unnecessary’ barrier to women who want access to a safe abortion,” quoting University of California-San Francisco reproductive professor Daniel Grossman as suggesting the FDA “might better use its resources to explore how the medically unnecessary restrictions could be lessened in order to improve access to safe abortion care.”
However, pro-lifers warn that even when “properly” taken, abortion pills are not only lethal to preborn children but more dangerous to women than advertised.
“As of December 2017, there were reports of 22 deaths of women associated with Mifeprex since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal,” the FDA warns, on top of 2,740 cases of severe complications from 2000 to 2012.