FDA Lifts Restriction on Remote Prescriptions of Abortion Drugs
Biden admin uses COVID to lift federal prohibition on telemedicine abortions Getty Graham Piro • April 13, 2021 6:25 pm
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The Biden administration cited the coronavirus pandemic to give the green light to at-home, self-administered abortions on Monday.
The FDA said it will allow the prescription of an abortion pill, mifepristone, through the mail, reversing Trump administration restrictions on remote prescription of abortion drugs. The agency wrote that because the in-person dispensing of mifepristone for medical termination of early pregnancy may present additional COVID-related risks to patients and healthcare personnel because it may involve a clinic visit solely for this purpose, it will allow doctors and nurses to prescribe the medication remotely.
Print article WASHINGTON Women seeking an abortion pill will not be required to visit a doctor’s office or clinic during the COVID-19 pandemic, U.S. health officials said Tuesday in the latest reversal in an ongoing legal battle over the medication. The Food and Drug Administration announced the policy change a day earlier in a letter to the American College of Obstetricians and Gynecologists, one of several medical groups that has sued over the restriction put in place under the Trump administration. The FDA’s acting head, Dr. Janet Woodcock, said an agency review of recent studies “do not appear to show increases in serious safety concerns,” when women take the pill without first visiting a health facility and discussing the drug’s potential risks, including internal bleeding.
FDA Halts Restrictions on Mailing Abortion Pills Amid COVID-19 Pandemic
Sputnik International
https://sputniknews.com/us/202104141082623709-fda-halts-restrictions-on-mailing-abortion-pills-amid-covid-19-pandemic/
Earlier, the US Supreme Court cleared a request by the Trump administration to reinstate restrictions that would require patients to pick up early pregnancy termination pills in person. The January decision came after lower courts barred the US Food and Drug Administration’s in-person pick-up requirement.
The FDA lifted restrictions on Monday on a commonly used abortion pill mifepristone, allowing health care providers in some US states the ability to dispense the medication without having to require in-person appointments.
Mifepristone was cleared for usage in the US in 2000, with the FDA approving a supplemental application in 2016. The drug itself is used only in cases where an individual seeks to end a pregnancy during the first 70 days of gestation.
Does J&J’s Covid‐19 Vaccine Pose Fewer Risks than Oral Contraceptives? SHARE
Earlier today, I wrote about the U.S. Food and Drug Administration’s recommendation that federal and state governments stop administering Johnson & Johnson’s Covid‐19 vaccine because the agency was “reviewing data involving six reported U.S. cases of a rare and severe type of blood clot…called cerebral venous sinus thrombosis (CVST).” Here, I thought I would do a back‐of‐the‐envelope comparison of this risk to that of another category of products on which the FDA has not placed a hold: oral contraceptives.
According to one literature review, the baseline risk of CVST among women is 3 per million per year and “the pooled odds of developing CVST in women of reproductive age taking oral contraceptives was 7.59 times the odds of developing CVST for those not taking oral contraceptives.” If so, the risk of CVST among oral contraceptives users is roughly 23
California will temporarily stop administering the Johnson & Johnson vaccine a move urged by federal officials following reports of six serious blood clots nationwide.