Investigative
Dismemberment abortions happening later in pregnancy despite 'lack of clinical guidelines'
Carole Novielli
·Spotlight Articles
Abortion Pill·By Carole Novielli
Judge allows online and pharmacy dispensing of abortion pill during COVID-19
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.
“Like” Live Action News on Facebook for more pro-life news and commentary!
Live Action News is pro-life news and commentary from a pro-life perspective.
Our work is possible because of our donors. Please consider giving to further our work of changing hearts and minds on issues of life and human dignity.
Contact editor@liveaction.org for questions, corrections, or if you are seeking permission to reprint any Live Action News content.
Guest Articles: To submit a guest article to Live Action News, email editor@liveaction.org with an attached Word document of 800-1000 words. Please also attach any photos relevant to your submission if applicable. If your submission is accepted for publication, you will be notified within three weeks. Guest articles are not compensated (see our Open License Agreement). Thank you for your interest in Live Action News!
Abortion Pill·By Carole Novielli
Judge allows online and pharmacy dispensing of abortion pill during COVID-19
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.
“Like” Live Action News on Facebook for more pro-life news and commentary!
Live Action News is pro-life news and commentary from a pro-life perspective.
Our work is possible because of our donors. Please consider giving to further our work of changing hearts and minds on issues of life and human dignity.
Contact editor@liveaction.org for questions, corrections, or if you are seeking permission to reprint any Live Action News content.
Guest Articles: To submit a guest article to Live Action News, email editor@liveaction.org with an attached Word document of 800-1000 words. Please also attach any photos relevant to your submission if applicable. If your submission is accepted for publication, you will be notified within three weeks. Guest articles are not compensated (see our Open License Agreement). Thank you for your interest in Live Action News!
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