ACOG Menu

Advocacy and Health Policy |

Court’s Order Lifting Burdensome FDA Restriction: What You Need to Know

Advertisement
 

This week, in response to a case filed by ACOG and other organizations, a federal court blocked FDA’s enforcement of a restriction that requires the in-person dispensing of mifepristone. In a statement, ACOG President Eva Chalas, MD, FACOG, FACS, commended the ruling as both a victory for patients and for the dedicated clinicians who are working to provide needed care without unnecessary exposure of patients, their families and the members of the healthcare team, to the novel coronavirus.

Background

ACOG undertook this legal challenge because during the COVID-19 pandemic – which is likely to impact the U.S. for many months to come – requiring in-person dispensing of mifepristone needlessly threatens both patients and clinicians.  Clear science and the consensus of the medical community underscore that mifepristone is a safe medication and the federal Food and Drug Administration’s in-person dispensing requirements provide no medical benefit to patients. Numerous medical organizations filed a brief supporting the case, noting that there is no medical basis for FDA’s decision to treat mifepristone differently than other medications. 

Further, the FDA’s burdensome in-person dispensing requirement for mifepristone has had a disproportionate effect on communities hit hardest by the pandemic, including communities of color who already face existing inequities and structural barriers to care. Suspending the in-person dispensing requirement for mifepristone for early pregnancy termination represents a necessary step forward in our collective work toward health equity during this unprecedented time of pandemic.

What does this mean for your practice?

This ruling will remove additional burdens imposed by FDA on patients seeking access to and clinicians prescribing mifepristone for pregnancy termination, however, there are several important considerations to take into account as you consider changes to your clinical practice.  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 court’s order means that FDA cannot prohibit clinicians from mailing mifepristone to eligible medication abortion patients during HHS’s declared COVID-19 Public Health Emergency.  However, all other requirements of the mifepristone Risk Evaluation and Mitigation Strategies (REMS) remain in place. 
  • The injunction unfortunately does not apply to the use of mifepristone for miscarriage care – only abortion care. The FDA’s in-person dispensing requirement is still in effect in the miscarriage context, although ACOG will continue to advocate for its removal.
  • All relevant state laws remain in effect and will impact whether the ruling would allow you to mail mifepristone to eligible patients. Examples of state laws that might prevent the mailing of mifepristone include laws explicitly restricting medication abortion via telemedicine, laws requiring in-person administration of mifepristone, as well as laws applying more generally to the dispensing of medications by mail. We reiterate that clinicians seeking to take advantage of the court’s ruling should consult with a lawyer about any state law restrictions.

Finally, it is important to note that this litigation is ongoing, and subject to appeal – which means that the status of the court’s ruling could change in the near future. ACOG will continue to provide our members with updates as the situation unfolds.  For questions please email govtrel@acog.org