アメリカの中絶薬の扱い（REMS）
COG News Releases | Apr 12, 2021
Washington, DC – The following is a statement from Eva Chalas, MD, FACOG, FACS, President of the American College of Obstetricians and Gynecologists (ACOG), and Maureen G. Phipps, MD, MPH, Chief Executive Officer of ACOG:
“ACOG applauds the U.S. Food and Drug Administration (FDA) for acknowledging the strong safety and efficacy profile of mifepristone for termination of early pregnancy. By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence—which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive.
“ACOG has for years advocated for the FDA to remove the in-person dispensing requirement for mifepristone, given that there is no safety reason for the restrictions and that the restrictions were more burdensome than those placed on medications with similar safety profiles, or even those with greater risks. Moreover, mifepristone itself has demonstrated, through both clinical study and decades of use, to be a safe, effective medication. Requiring the medicine to be dispensed in person, then taken elsewhere at the patients’ discretion, is arbitrary and does nothing to bolster the safety of an already-safe medicine.
“When the COVID-19 pandemic began, ACOG recognized that the in-person dispensing requirement for mifepristone was not just burdensome, it was also dangerous. Requiring physical dispensing of mifepristone potentially exposed both the clinician and the patient to COVID-19 infection, and clearly represented an undue burden on both parties. These restrictions also disproportionately negatively impact communities hit hardest by the pandemic, including communities of color. That's why ACOG petitioned the FDA in court to halt enforcement of the requirement through the duration of the public health emergency. Not surprisingly, during the six-month span of the injunction on the in-person dispensing requirement, no safety signals appeared with use of mifepristone for termination of pregnancy—an important data point that the FDA itself included in its letter announcing its decision.
“Now, thanks to the FDA’s intent to exercise discretion in enforcing the in-person dispensing requirement, those in need of an abortion will be able to do so safety and effectively by acquiring mifepristone though the mail—just as they would any other medication with a similarly strong safety profile. We are pleased to see mifepristone regulated on the basis of the scientific evidence during the pandemic, rather than political bias against comprehensive reproductive health care, and we look forward to working with policy makers to ensure this principle governs post-pandemic care.”
Mifepristone, Shared System REMS, REMS last update: 05/14/2021
USA Food & Drug Administration: Mifeprex (mifepristone) Information
