USA: STOP PRESS x 2 ! – Access to mifepristone by mail or delivery reinstated by US FDA for duration of Covid-19 pandemic – announced 12 April 2021

The American Civil Liberties Union (ACLU) writes: “We write with wonderful news! The US Food & Drug Administration (FDA) has sent a letter to the American College of Obstetrics & Gynecology stating that they do not intend to enforce the in-person dispensing requirements for medical abortion pills for the remainder of the Covid-19 Public Health Emergency. The letter covers both direct mailing and mail-order pharmacies. It protects both medical abortion and miscarriage patients and is effective immediately.”

“This is a HUGE win!!”, they write.

The history: In July 2020, a federal court blocked the FDA from enforcing the in-person dispensing requirements, allowing abortion providers to deliver mifepristone to patients by mail or delivery (including through supervised mail-order pharmacies) during the Covid-19 emergency. The Trump Administration then went all the way up to the Supreme Court (twice) for permission to reinstate these harmful requirements while the litigation proceeded, and in January 2021, the Supreme Court reinstated the requirements.

With this new letter, the in-person dispensing requirement, and related requirement that the Patient Agreement be signed in-person, are again suspended for the duration of the pandemic. All other (REMS) requirements remain in place (and state laws still apply, so ACLU urges everyone to consult with a lawyer before making changes to their protocols.)

The FDA’s letter relied on several studies that “do not appear to show increases in serious safety concerns … occurring with medical abortion as a result of modifying the in-person dispensing requirement during the Covid-19 pandemic”.

SOURCE: ACLU Reproductive Freedom Project, ACLU press statement, 12 April 2021 ; VISUAL by Carla Indipendente, in Marie Claire, 13 January 2021