According to a modified court order, United States District Judge Theodore D. Chuang has removed yet another hurdle for the abortion industry’s goal of DIY at-home abortions. Now, abortion clients can obtain the abortion pill online and in pharmacies without being seen in person by a health professional during the COVID-19 pandemic.
In July 2020, Chuang ruled to suspend in-person visit requirements for the abortion pill during the pandemic, which are required by the U.S. Food and Drug Administration’s (FDA) safety protocols (REMS). The lawsuit, filed on behalf of the American College of Obstetricians and Gynecologists against the FDA asserts that requiring mifepristone to be dispensed to abortion clients in person during the COVID-19 pandemic is an undue burden. The FDA has defended its safety requirements.
READ: FDA files appeal after judge suspends abortion pill safety rules during COVID-19
Under FDA’s REMS, mifepristone (used in a regimen with misoprostol) must be dispensed by a certified prescriber at an approved hospital or clinic and cannot be sold online or in a pharmacy. However, Chuang’s modification to the preliminary injunction as of August 19, 2020, now allows pharmacies to act as “an agent” of the certified abortion pill prescribers and to store abortion pills “on behalf of the healthcare provider.” While the order allows a pharmacy to stock and subsequently mail abortion pills for a certified prescriber, it limits them from “acting as a retail pharmacy” and stocking the abortion pills generally or distributing the abortion pill outside of certified prescribers. How a pharmacy will confirm the prescription requests are from Danco certified prescribers is not noted since Danco does not publish a list.
The order reads in part:
This requirement that dispensing by mail or delivery service remain “by or under the supervision of a certified healthcare provider” permits mifepristone to be sent from a drug sponsor to a certified healthcare provider in the care of a mail-order pharmacy if the pharmacy has a contractual agreement with the certified healthcare provider to receive mifepristone on behalf of the healthcare provider and then to mail the drug to a patient at the direction of that healthcare provider, so long as the drugs were specifically ordered from the drug sponsor by the certified healthcare provider and held on the provider’s behalf, and the mail-order pharmacy has no right to distribute those drugs except at the direction of the certified healthcare provider.
“In this regard, the arrangement does not conflict with the Court’s statements that certified healthcare providers must ‘still comply with all other REMS requirements’ and that the Court ‘is not barring the enforcement of other REMS requirements not dependent on an in-person patient visit,’ the document obtained by Live Action News states.
Live Action’s investigative report on the abortion pill has documented how the abortion industry has recently increased its calls for DIY abortions, even rolling out a “no test” abortion pill protocol (here and here.) But this “no test” protocol was planned well before the COVID-19 pandemic.
Gynuity Health Projects (GHP) is sponsoring a rapidly expanding TelAbortion clinical trial which offers the abortion pill to children as young as 10. Abortionist Daniel Grossman is behind two trials for pharmacy dispensing of the abortion pill, via both brick and mortar and online pharmacies. These trials are sponsored by the Buffett Foundation-funded University of California at San Francisco where Grossman is on staff. Grossman’s study sites include pharmacies affiliated with the University of California and the University of Washington, which could now be tapped for dispensing abortion pills under the latest order. Grossman is also on staff as a Senior Advisor at Ibis Reproductive Health, which acknowledged receiving direct funding from Danco as recently as January 2020, long after these clinical trials began.
The abortion pill has killed at least 24 women, and millions of preborn children. Although thousands of adverse effects have been reported, many with serious complications, the FDA no longer requires Danco to report anything other than deaths. As a result, a coalition of organizations led by Live Action sent a letter to the FDA calling on Commissioner Stephen Hahn to remove the abortion pill (mifepristone) and its approved generics (for its indication and usage to end early pregnancy) from the U.S. market.
Editor’s Note: FDA has received reports of serious adverse events in women who took mifepristone. As of June 30, 2021, there were reports of 26 deaths of women associated with mifepristone since the product was approved in September 2000, including two cases of ectopic pregnancy (a pregnancy located outside the womb, such as in the fallopian tubes) resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal. The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient. A summary report of adverse events that reflects data through June 30, 2021 is here.
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