Document ID: ./input/supremecourt_opinions/opinions/23pdf/23-235_n7ip.pdf
Page Number: 8.0

4 

FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE 

Opinion of the Court 

Texas.  Plaintiffs brought claims under the Administrative 
Procedure  Act.    They  challenged  the  lawfulness  of  FDA’s 
2000 approval of Mifeprex; FDA’s 2019 approval of generic 
mifepristone; and FDA’s 2016 and 2021 actions modifying 
mifepristone’s conditions of use.  Danco Laboratories, which 
sponsors  Mifeprex,  intervened  to  defend  FDA’s  actions.
The  plaintiffs  moved  for  a  preliminary  injunction  that
would require FDA to rescind approval of mifepristone or, 
at the very least, to rescind FDA’s 2016 and 2021 actions. 
The District Court agreed with the plaintiffs and in effect
enjoined FDA’s approval of mifepristone, thereby ordering 
mifepristone off the market.  668 F. Supp. 3d 507 (ND Tex. 
2023).  The  court  first  held  that  the  plaintiffs  possessed
Article III standing.  It then determined that the plaintiffs
were likely to succeed on the merits of each of their claims.
Finally, the court concluded that the plaintiffs would suffer 
irreparable  harm  from  FDA’s  continued  approval  of
mifepristone and that an injunction would serve the public
interest. 

FDA and Danco promptly appealed and moved to stay the
District Court’s order pending appeal.  The U. S. Court of 
Appeals  for  the  Fifth  Circuit  granted  the  stay  motion  in 
part  and  temporarily  reinstated  FDA’s  approval  of 
Mifeprex.  2023 WL 2913725, *21 (Apr. 12, 2023).  But the 
Court  of  Appeals  declined  to  stay  the  rest  of  the  District
Court’s  order.    The  Court  of  Appeals’  partial  stay  would
have left Mifeprex (though not generic mifepristone) on the 
market,  but  only  under  the  more  stringent  requirements 
imposed  when  FDA  first  approved  Mifeprex  in  2000—
available only up to seven weeks of pregnancy, only when
prescribed by doctors, and only with three in-person visits,
among other requirements.

FDA  and  Danco  then  sought  a  full  stay  in  this  Court.
This Court stayed the District Court’s order in its entirety
pending the disposition of FDA’s and Danco’s appeals in the 
Court of Appeals and ultimate resolution by this Court.  598