The FDA's Decision Lifting the Burdensome Restriction on Mifepristone during the Pandemic: What You Need to Know

This article was published on July 15, 2020, and was updated on April 21, 2021, to reflect new information.

On April 13, 2021, the FDA issued a letter to ACOG and the Society for Maternal–Fetal Medicine announcing that it will not enforce the in-person dispending requirement for mifepristone for the duration of the COVID-19 public health emergency. The FDA has updated its website to reflect this decision. This move came in response to advocacy on the part of ACOG and the broader medical and scientific communities.

Earlier in the pandemic, ACOG led a coalition in filing a case in federal court seeking to block the prior administration’s policy, which imposed an in-person dispensing requirement on mifepristone. This requirement restricted access and exposed clinicians and patients to undue risk. The case successfully blocked the requirement for six months. The Supreme Court paused the injunction, however, enabling the FDA to re-impose the requirement shortly before President Biden was inaugurated.

Clear science and the consensus of the medical community underscore that mifepristone is a safe medication and that the FDA’s in-person dispensing requirement provides no medical benefit to patients. The FDA’s requirement for mifepristone has had a disproportionately burdensome effect on communities hit hardest by the pandemic, including people of color, who already face multiple inequities and structural barriers to care. Suspending the in-person dispensing requirement for mifepristone for early pregnancy termination and miscarriage care represents a necessary step forward in our collective work toward health equity during this unprecedented time. We are hopeful that the agency will continue to prioritize evidence and equity even in non-pandemic times.

What Does This Mean for Your Practice?

The FDA has lifted additional burdens on patients seeking access to and clinicians prescribing mifepristone for pregnancy termination and miscarriage during the COVID-19 public health emergency. As you consider changes to your clinical practice, however, please take several important factors into account. Whether you now have authority to mail mifepristone is a fact-specific, state-specific legal question. We strongly encourage any clinician seeking this relief to consult with a lawyer before making any changes to your clinical practice.

You should be aware of the following:

• The FDA has updated its policy regarding mifepristone access during the pandemic.
• While the FDA has decided to permit mailing mifepristone to eligible patients during the Department of Health and Human Services’ declared COVID-19 public health emergency, all other requirements of the mifepristone risk evaluation and mitigation strategies remain in place.
• All relevant state laws remain in effect and will help determine whether the ruling allows you to mail mifepristone to eligible patients. Examples of state laws that might prevent the mailing of mifepristone include statutes explicitly restricting medication abortion through telemedicine, laws requiring in-person administration of mifepristone, and laws applying more generally to the dispensing of medications by mail.
• We reiterate that clinicians seeking to use the flexibility provided by the FDA should consult a lawyer about any state law restrictions.

ACOG will continue to provide our members with updates as the situation unfolds. Please email your questions to [email protected].