Due to the COVID-19 pandemic, the Food and Drug Administration (FDA) has decided to halt enforcement of in-person dispensing of mifepristone and will allow dispensing through the mail either by or under the supervision of a certified prescriber, or through a mail-order pharmacy when the dispensing is done under the supervision of a certified prescriber.
Mifepristone is a progestin antagonist indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. The action was taken following a petition from the American College of Obstetricians and Gynecologists (ACOG) over concerns that the need for a clinic visit solely for the purpose of dispensing the medication would put patients and healthcare personnel at increased risk for COVID-19.
To make an informed decision, the FDA conducted a literature search for studies related to the in-person dispensing requirement in the Mifepristone REMS program during the COVID-19 pandemic. Four publications were identified that included relevant clinical outcomes. Findings from these investigations revealed no increase in safety concerns as a result of modifying the in-person dispensing requirement during the pandemic. In addition, a review of postmarketing adverse events reported between January 27, 2020 and January 12, 2021 found no association between these events and program deviations or noncompliance.
In an April 12, 2021 letter, the Agency stated that provided that other requirements of the Mifepristone REMS program are being met, it “intends to exercise enforcement discretion during the COVID-19 [public health emergency] with respect to the in-person dispensing requirement of the Mifepristone REMS Program, including any in-person requirements that may be related to the Patient Agreement Form.”
In response to the decision, Eva Chalas, MD, FACOG, FACS, President of ACOG, and Maureen G. Phipps, MD, MPH, Chief Executive Officer of ACOG said: “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.”
ACOG Applauds the FDA for its Action on Mifepristone Access During the COVID-19 Pandemic. [press release]. Washington, DC: American College of Obstetricians and Gynecologists; April 12, 2021.