Document ID: ./input/supremecourt_opinions/opinions/23pdf/23-235_n7ip.pdf
Page Number: 6.0

2 

FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE 

Opinion of the Court 

I 
A 

law, 

Under 

federal 

the  U. S.  Food  and  Drug
Administration,  an  agency  within  the  Executive  Branch, 
ensures  that  drugs  on  the  market  are  safe  and  effective. 
For FDA to approve a new drug, the drug sponsor (usually 
the  drug’s  manufacturer  or  potential  marketer)  must 
submit an application demonstrating that the drug is safe
and  effective  when  used  as  directed.    21  U. S. C.  §355(d). 
The sponsor’s application must generally include proposed 
labeling  that  specifies  the  drug’s  dosage,  how  to  take  the
drug, and the specific conditions that the drug may treat.
21 CFR §§201.5, 314.50 (2022). 

If  FDA  determines  that  additional  safety  requirements
are  necessary,  FDA  may  impose  extra  requirements  on 
prescription and use of the drug.  21 U. S. C. §355–1(f )(3).  
For  example,  FDA  may  require  that  prescribers  undergo 
specialized  training;  mandate  that  the  drug  be  dispensed 
only in certain settings like hospitals; or direct that doctors
monitor patients taking the drug.  Ibid. 

In  2000,  FDA  approved  a  new  drug  application  for
mifepristone  tablets  marketed  under  the  brand  name 
Mifeprex.  FDA  approved  Mifeprex  for  use  to  terminate 
pregnancies, but only up to seven weeks of pregnancy.  To 
help  ensure  that  Mifeprex  would  be  used  safely  and
effectively,  FDA  placed  further  restrictions  on  the  drug’s
use  and  distribution.  For  example,  only  doctors  could 
prescribe  or  supervise  prescription  of  Mifeprex.    Doctors 
and patients also had to follow a strict regimen requiring
the  patient  to  appear  for  three  in-person  visits  with  the
doctor.  And  FDA  directed  prescribing  doctors  to  report
incidents  of  hospitalizations,  blood  transfusions,  or  other 
serious  adverse  events  to  the  drug  sponsor  (who,  in  turn, 
was required to report the events to FDA).

In  2015,  Mifeprex’s  distributor  Danco  Laboratories 
submitted a supplemental new drug application seeking to