Comment from Anonymous

AnonymousOpposeIndividual
Summary: A certified Acute Care Nurse Practitioner opposes the proposed action to loosen restrictions on mifepristone and misoprostol. The commenter argues that mail-order dispensing lacks adequate supervision and calls for reinstated REMS, mandatory ultrasounds, and stricter reporting of adverse events to ensure patient safety.
I am a certified Acute Care Nurse Practitioner who is contacting you to request you do not loosen the restrictions related to the abortion drugs mifepristone and misoprostol. Women seeking an abortion deserve close care and supervision of a health care provider, ideally I believe to understand the value of their life and the life of their unborn child and the implications of their choices, but at the minimum to guide them to an informed decision. A mail order dispensing of the drugs mifepristone and misoprostol, is not providing informed health care or adequate follow up. The recent data from the EPPC study should lead to heightened concern and tightened restrictions of dispensing these drugs, not the opposite. I would urge the FDA to immediately reinstate reporting of ALL adverse events related to mifepristone use and reinstate the pre-2016 Risk Evaluation and Mitigation Strategies (REMS), including limiting use of the drug to seven weeks gestation and requiring in-person dispensing as well as follow up. I also urge the FDA to require ultrasounds to confirm gestational age (crucial to accurately dating a pregnancy and determining the risk of complications) and to rule out ectopic pregnancy, which is a life-threatening condition. Women deserve appropriate and close care, especially in crisis and vulnerable times, and dispensing mifepristone and misoprostol without evaluation of gestational age or checking for ectopic pregnancy, as well as having follow up for potential complications like retained tissue is negligence. Please protect women and those who care for them from unnecessary harm, by not loosening restrictions on mifepristone and misoprostol. Thank you for your thorough consideration.

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