Document ID: ./input/supremecourt_opinions/opinions/23pdf/23-235_n7ip.pdf
Page Number: 1

(Slip Opinion) 

OCTOBER  TERM,  2023 

1 

Syllabus 

NOTE:  Where  it  is  feasible,  a  syllabus  (headnote)  will  be  released,  as  is 
being  done  in  connection  with  this  case,  at  the  time  the  opinion  is  issued. 
The  syllabus  constitutes  no  part  of  the  opinion  of  the  Court  but  has  been 
prepared  by  the  Reporter  of  Decisions  for  the  convenience  of  the  reader. 
See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337. 

SUPREME COURT OF THE UNITED STATES 

Syllabus 

FOOD AND DRUG ADMINISTRATION ET AL. v. 
ALLIANCE FOR HIPPOCRATIC MEDICINE ET AL. 

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR 
THE FIFTH CIRCUIT 

No. 23–235.  Argued March 26, 2024—Decided June 13, 2024* 

In  2000,  the  Food  and  Drug  Administration  approved  a  new  drug
application for mifepristone tablets marketed under the brand name
Mifeprex  for  use  in  terminating  pregnancies  up  to  seven  weeks.    To 
help ensure that Mifeprex would be used safely and effectively, FDA 
placed  additional  restrictions  on  the  drug’s  use  and  distribution,  for 
example requiring doctors to prescribe or to supervise prescription of
Mifeprex,  and  requiring  patients  to  have  three  in-person  visits  with 
the  doctor  to  receive  the  drug.    In  2016,  FDA  relaxed  some  of  these 
restrictions: deeming Mifeprex safe to terminate pregnancies up to 10 
weeks; allowing healthcare providers, such as nurse practitioners, to
prescribe Mifeprex; and approving a dosing regimen that required just
one  in-person  visit  to  receive  the  drug.    In  2019,  FDA  approved  an 
application for generic mifepristone.  In 2021, FDA announced that it 
would no longer enforce the initial in-person visit requirement.  Four 
pro-life medical associations and several individual doctors moved for 
a  preliminary  injunction  that  would  require  FDA  either  to  rescind
approval of mifepristone or to rescind FDA’s 2016 and 2021 regulatory
actions.  Danco Laboratories, which sponsors Mifeprex, intervened to 
defend FDA’s actions. 

The District Court agreed with the plaintiffs and in effect enjoined 
FDA’s approval of mifepristone, thereby ordering mifepristone off the 
market.  FDA  and  Danco  appealed  and  moved  to  stay  the  District
Court’s order pending appeal.  As relevant here, this Court ultimately 

—————— 

*Together with No. 23–236, Danco Laboratories, L.L.C. v. Alliance for 
Hippocratic  Medicine,  also  on  certiorari  to  the  United  States  Court  of 
Appeals for the Fifth Circuit.