FDA waives mifepristone’s in-person dispensing requirement
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The FDA, citing potential “risks to patients and health care personnel,” said it will waive mifepristone’s in-person dispensing requirement during the COVID-19 public health emergency.
The in-person requirement for mifepristone, an FDA-approved medication for nonsurgical abortion, can be removed so long as other requirements of its Risk Evaluation Mitigation Strategy program are met, including that prescribers know how to gauge the length of a pregnancy, diagnose ectopic pregnancies and provide — or have a plan in place to provide — surgery when an incomplete abortion or incidence of severe bleeding occurs.
Acting FDA Commissioner Janet Woodcock, MD, informed American College of Obstetricians and Gynecologists (ACOG) CEO Maureen G. Phipps, MD, MPH, FACOG, and others of the FDA’s decision in a letter dated April 12.
According to the correspondence, the FDA’s decision was based on an internal review of four previously published studies that found that overall, there were no “increases in serious safety concerns (such as hemorrhage, ectopic pregnancy or surgical interventions) occurring with medical abortion as a result of modifying the in-person dispensing requirement during the COVID-19 pandemic.”
Phipps, who oversaw ACOG’s legal petition to the FDA for a temporary injunction of mifepristone’s in-person dispensing requirement, applauded the FDA decision.
“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,” she said in a statement.
References
FDA.gov. Risk evaluation and mitigation strategy (RMS) single shared system for mifepristone 200 mg. https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Full.pdf. Accessed April 13, 2021.
Letter from Janet Woodcock, MD, to Maureen Phipps, MD, et al. Accessed April 12, 2021.
Perspective
Back to TopKatharine O'Connell White, MD, MPH
It’s a wonderful day for women and all pregnancy-capable people when science triumphs over ideology at the FDA. I’m overjoyed that the FDA has loosened the restrictions on access to mifepristone during the time of the COVID-19 pandemic.
Mifepristone has a long track record of safety, and new evidence from the last year confirms that it is a safe medication for people to self-administer under a clinician’s supervision.
My hope is that the FDA’s decision allows people to access the abortion care they need under these incredibly stressful circumstances. And I also hope that this is the first step toward permanently improving access to this important medication.
Associate professor of obstetrics and gynecology
Boston University and Boston Medical Center
Perspective
Back to Top
The FDA's decision to halt burdensome and unnecessary requirements for in-person dispensing of mifepristone is clearly warranted by the medication's long history and safety profile. The special restrictions put on mifepristone due to abortion politics have been particularly onerous during the COVID-19 pandemic when in-person services were even more limited across the country.
What a relief to have our government agencies driven by science.
Director, Maternal Child Health Certificate
Rutgers School of Public Health, New Jersey
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