in identifying covered drugs, the Secretary may do one or 
both of the following: 
‘‘(1) Enter into cooperative agreements or con-
tracts with public or private entities to review the 
available scientific evidence concerning such drugs. 
‘‘(2) Seek public input concerning such drugs, 
including input on whether there is a relevant ac-
cepted use in clinical practice that is not reflected in 
the approved labeling of such drugs or whether new 
scientific evidence is available regarding the condi-
tions of use for such drug, by— 
‘‘(A) holding one or more public meetings; 
‘‘(B) opening a public docket for the sub-
mission of public comments; or 
‘‘(C) other means, as the Secretary deter-
mines appropriate. 
‘‘(c) SELECTION OF DRUGS FOR UPDATING.—If the 
Secretary determines, with respect to a covered drug, that 
the available scientific evidence meets the standards under 
section 505 for adding or modifying information to the 
labeling or providing supplemental information to the la-
beling regarding the use of the covered drug, the Secretary 
may initiate the process under subsection (d). 
‘‘(d) INITIATION OF THE PROCESS OF UPDATING.— 
If the Secretary determines that labeling changes are ap-
VerDate Sep 11 2014 
23:42 Jan 24, 2020
Jkt 099200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H5668.IH
H5668
kjohnson on DSK79L0C42PROD with BILLS
propriate for a selected drug pursuant to subsection (c), 
the Secretary shall provide notice to the holders of ap-
proved applications for a generic version of such drug 
that— 
‘‘(1) summarizes the findings supporting the 
determination of the Secretary that the available sci-
entific evidence meets the standards under section 
505 for adding or modifying information or pro-
viding supplemental information to the labeling of 
the covered drug pursuant to subsection (c); 
‘‘(2) provides a clear statement regarding the 
additional, modified, or supplemental information for 
such labeling, according to the determination by the 
Secretary (including, as applicable, modifications to 
add the relevant accepted use to the labeling of the 
drug as an additional indication for the drug); and 
‘‘(3) states whether the statement under para-
graph (2) applies to the selected drug as a class of 
covered drugs or only to a specific drug product. 
‘‘(e) RESPONSE TO NOTIFICATION.—Within 30 days 
of receipt of notification provided by the Secretary pursu-
ant to subsection (d), the holder of an approved applica-
tion for a generic version of the selected drug shall— 
‘‘(1) agree to change the approved labeling to 
reflect the additional, modified, or supplemental in-
VerDate Sep 11 2014 
23:42 Jan 24, 2020
Jkt 099200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H5668.IH
H5668
kjohnson on DSK79L0C42PROD with BILLS
formation the Secretary has determined to be appro-
priate; or 
‘‘(2) notify the Secretary that the holder of the 
approved application does not believe that the re-
quested labeling changes are warranted and submit 
a statement detailing the reasons why such changes 
are not warranted. 
‘‘(f) REVIEW
OF
APPLICATION
HOLDER’S
RE-
SPONSE.— 
‘‘(1) IN GENERAL.—Upon receipt of the appli-
cation holder’s response, the Secretary shall prompt-
ly review each statement received under subsection 
(e)(2) and determine which labeling changes pursu-
ant to the Secretary’s notice under subsection (d) 
are appropriate, if any. If the Secretary disagrees 
with the reasons why such labeling changes are not 
warranted, the Secretary shall provide opportunity 
for discussions with the application holders to reach 
agreement on whether the labeling for the covered 
drug should be updated to reflect available scientific 
evidence, and if so, the content of such labeling 
changes. 
‘‘(2) CHANGES
TO
LABELING.—After consid-
ering all responses from the holder of an approved 
application under paragraph (1) or (2) of subsection 
VerDate Sep 11 2014 
23:42 Jan 24, 2020
Jkt 099200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H5668.IH
H5668
kjohnson on DSK79L0C42PROD with BILLS
(e), and any discussion under paragraph (1), the 
Secretary may order such holder to make the label-
ing changes the Secretary determines are appro-
priate and meet the standards under section 505 for 
adding or modifying information or providing sup-
plemental information to such labeling. Such holder 
of an approved application shall— 
‘‘(A) update its paper labeling for the drug 
at the next printing of that labeling; 
‘‘(B) update any electronic labeling for the 
drug within 30 days of such order; and 
‘‘(C) submit the revised labeling through 
the form, ‘Supplement—Changes Being Ef-
fected’. 
‘‘(g) VIOLATION.—If the holder of an approved appli-
cation for the generic version of the selected drug does 
not comply with the requirements of subsection (f)(2), 
such generic version of the selected drug shall be deemed 
to be misbranded under section 502. 
‘‘(h) LIMITATIONS; GENERIC DRUGS.— 
‘‘(1) IN GENERAL.—With respect to any label-
ing change required under this section, the generic 
version shall be deemed to have the same conditions 
of use and the same labeling as a reference drug for 
purposes 
of 
clauses 
(i) 
and 
(v) 
of 
section 
VerDate Sep 11 2014 
23:42 Jan 24, 2020
Jkt 099200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H5668.IH
H5668
kjohnson on DSK79L0C42PROD with BILLS
505(j)(2)(A). Any labeling change so required shall 
not have any legal effect for the applicant that is 
different than the legal effect that would have re-
sulted if a supplemental application had been sub-
mitted and approved to conform the labeling of the 
generic version to a change in the labeling of the ref-
erence drug. 
‘‘(2) SUPPLEMENTAL APPLICATIONS.—Changes 
to labeling made in accordance with this section 
shall not be eligible for an exclusivity period under 
this Act. 
‘‘(i) RULES OF CONSTRUCTION.— 
‘‘(1) APPROVAL
STANDARDS.—This section 
shall not be construed as altering the applicability of 
the standards for approval of an application under 
section 505. No order shall be issued under this sub-
section unless the scientific evidence supporting the 
changed labeling meets the standards for approval 
applicable to any change to labeling under section 
505. 
‘‘(2) SECRETARY AUTHORITY.—Nothing in this 
section shall be construed to limit the authority of 
the Secretary to require labeling changes under sec-
tion 505(o). 
VerDate Sep 11 2014 
23:42 Jan 24, 2020
Jkt 099200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H5668.IH
H5668
kjohnson on DSK79L0C42PROD with BILLS
‘‘(j) REPORTS.—Not later than 4 years after the date 
of the enactment of the Making Objective Drug Evidence 
Revisions for New Labeling Act of 2020, and every 4 years 
thereafter, the Secretary shall prepare and submit to the 
Committee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Commerce 
of the House of Representatives, a report that— 
‘‘(1) describes the actions of the Secretary 
under this section, including— 
‘‘(A) the number of covered drugs and de-
scription of the types of drugs the Secretary 
has selected for labeling changes and the ra-
tionale for such recommended changes; and 
‘‘(B) the number of times the Secretary 
entered into discussions concerning a disagree-
ment with an application holder or holders and 
a summary of the decision regarding a labeling 
change, if any; and 
‘‘(2) includes any recommendations of the Sec-
retary for modifying the program under this sec-
tion.’’. 
Æ 
VerDate Sep 11 2014 
23:42 Jan 24, 2020
Jkt 099200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6301
E:\BILLS\H5668.IH
H5668
kjohnson on DSK79L0C42PROD with BILLS