Document ID: ./input/supremecourt_opinions/opinions/23pdf/23-235_n7ip.pdf
Page Number: 7.0

Cite as:  602 U. S. ____ (2024) 

3 

Opinion of the Court 

amend  Mifeprex’s  labeling  and  to  relax  some  of  the 
restrictions that FDA had imposed.  In 2016, FDA approved 
the  proposed  changes.  FDA  deemed  Mifeprex  safe  to
terminate pregnancies up to 10 weeks rather than 7 weeks. 
FDA  allowed  healthcare  providers  such  as  nurse 
practitioners to prescribe Mifeprex.  And FDA approved a
dosing  regimen  that  reduced  the  number  of  required  in-
person  visits  from  three  to  one—a  single  visit  to  receive 
Mifeprex.  In  addition,  FDA  changed  prescribers’  adverse
event reporting obligations to require prescribers to report
only fatalities—a reporting requirement that was still more 
stringent than the requirements for most other drugs.

In  2019,  FDA  approved  an  application  for  generic 
mifepristone.  FDA established the same conditions of use 
for generic mifepristone as for Mifeprex. 

In  2021,  FDA  again  relaxed  the  requirements  for 
Mifeprex and generic mifepristone.  Relying on experience 
gained  during  the  COVID–19  pandemic  about  pregnant 
women using mifepristone without an in-person visit to a 
healthcare  provider,  FDA  announced  that  it  would  no
longer enforce the initial in-person visit requirement. 

B 
Because  mifepristone  is  used  to  terminate  pregnancies,
FDA’s  approval  and  regulation  of  mifepristone  have
generated substantial controversy from the start.  In 2002, 
three pro-life associations submitted a joint citizen petition
asking  FDA  to  rescind  its  approval  of  Mifeprex.  FDA 
denied their petition.

In  2019,  two  pro-life  medical  associations  filed  another
petition,  this  time  asking  FDA  to  withdraw  its  2016 
modifications  to  mifepristone’s  conditions  of  use.    FDA 
denied that petition as well. 

This  case  began  in  2022. 

Four  pro-life  medical
associations,  as  well  as  several  individual  doctors,  sued 
FDA in the U. S. District Court for the Northern District of