‘‘(iii) the Secretary and the sponsor have 
agreed on a timeframe, including designated 
milestones, for the prompt completion of the 
study, which timeframe assumes due diligence 
by the sponsor in conducting the study. 
‘‘(C) The Secretary shall require that, after the 
application is approved under such subpart and the 
drug enters commercial distribution, the drug be 
marketed in accordance with the following: 
‘‘(i) The distribution and use of the drug 
shall be restricted in accordance with such sub-
part. 
‘‘(ii) Until the Secretary determines that 
the sponsor has fulfilled its commitments under 
subparagraphs (A) and (B), the labeling of the 
drug shall bear— 
‘‘(I) a statement that the Food and 
Drug Administration is requiring a study 
or studies to confirm the safety and effec-
tiveness of the drug; and 
‘‘(II) a statement providing a clear 
and concise summary of the outstanding 
issues or questions to be addressed in such 
required studies. 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
‘‘(iii) Until the Secretary determines that 
the sponsor has fulfilled its commitments under 
subparagraphs (A) and (B), the labeling of the 
drug shall bear a statement providing as fol-
lows: ‘This product received conditional ap-
proval from the FDA under its accelerated ap-
proval process. It will not receive full approval 
until completion of further testing to confirm 
safety and/or efficacy. For further information 
please contact your physician.’. 
‘‘(iv) Direct-to-consumer advertisements 
for the drug shall be restricted until— 
‘‘(I) the Secretary determines that the 
sponsor has fulfilled its commitments 
under subparagraphs (A) and (B); and 
‘‘(II) the drug has been approved 
under such part 314 independently of sub-
part H of such part. 
‘‘(2) The Secretary shall amend part 314 of title 21, 
Code of Federal Regulations, to establish the following 
policies regarding postmarket studies that, on or after the 
date of the enactment of the SAFE Drug Act, are required 
pursuant to approval of a new drug under subpart H of 
such part or under section 506(b)(2) of this Act: 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
‘‘(A) If a required study is not completed by 
two years after the date on which the new drug was 
so approved, the Secretary shall, promptly after the 
expiration of such period, convene a public meeting 
of the appropriate advisory committee to review the 
progress of the study. Such review shall include the 
assessment of compliance with the timeframe for 
prompt completion of the study as agreed to by the 
company and the Secretary under paragraph 
(1)(B)(iii) or under section 506(b)(2) (as the case 
may be), the quality of study conduct, rates of en-
rollment overall and by institution, the barriers to 
progress, and whether the sponsor is acting with due 
diligence. At the meeting, the advisory committee 
shall determine whether it is in the best interest of 
the public to allow the sponsor to continue mar-
keting the drug until the study is completed or 
whether it is in the best interest of the public to sus-
pend the commercial marketing of the drug until the 
study is completed. 
‘‘(B) If the drug was approved on the basis of 
animal efficacy data because human efficacy studies 
are not ethical or feasible, the holder of the ap-
proved application shall conduct studies when ethical 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS