IIB 
116TH CONGRESS 
2D SESSION 
H. R. 5668 
IN THE SENATE OF THE UNITED STATES 
NOVEMBER 18, 2020 
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic Act to 
modernize the labeling of certain generic drugs, and for 
other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Making Objective Drug 
Evidence Revisions for New Labeling Act of 2020’’ or the 
‘‘MODERN Labeling Act of 2020’’. 
SEC. 2. MODERNIZING THE LABELING OF CERTAIN GE-
NERIC DRUGS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 503C the following: 
‘‘SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN 
DRUGS. 
‘‘(a) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘covered drug’ means a drug ap-
proved under section 505(c)— 
‘‘(A) for which there are no unexpired pat-
ents included in the list under section 505(j)(7) 
and no unexpired period of exclusivity; 
‘‘(B) for which the approval of the applica-
tion has been withdrawn for reasons other than 
safety or effectiveness; and 
‘‘(C) for which— 
‘‘(i)(I) there is new scientific evidence 
available pertaining to the existing condi-
tions of use that is not reflected in the la-
beling; 
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‘‘(II) the approved labeling does not 
reflect current legal and regulatory re-
quirements for content or format; or 
‘‘(III) there is a relevant accepted use 
in clinical practice that is not reflected in 
the approved labeling; and 
‘‘(ii) updating the labeling would ben-
efit the public health. 
‘‘(2) The term ‘period of exclusivity’, with re-
spect to a drug approved under section 505(c), 
means any period of exclusivity under clause (ii), 
(iii), or (iv) of section 505(c)(3)(E), clause (ii), (iii), 
or (iv) of section 505(j)(5)(F), or section 505A, 
505E, or 527. 
‘‘(3) The term ‘generic version’ means a drug 
approved under section 505(j) whose reference listed 
drug is a covered drug. 
‘‘(4) The term ‘relevant accepted use’ means a 
use for a drug in clinical practice that is supported 
by scientific evidence that appears to the Secretary 
to meet the standards for approval under section 
505. 
‘‘(5) The term ‘selected drug’ means a covered 
drug for which the Secretary has determined 
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through the process under subsection (c) that the la-
beling should be changed. 
‘‘(b) IDENTIFICATION
OF COVERED DRUGS.—The 
Secretary may identify covered drugs for which labeling 
updates would provide a public health benefit. To assist 
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 
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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-
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. 
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‘‘(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-
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 
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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 
(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. 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.— 
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‘‘(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 its reference listed 
drug for purposes of clauses (i) and (v) of section 
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. 
‘‘(3) SELECTION OF DRUGS.—Nothing in this 
section shall be construed to give the Secretary the 
authority to identify a drug as a covered drug or se-
lect a drug label for updating solely based on the 
availability of new safety information. Upon identi-
fication of a drug as a covered drug, the Secretary 
may then consider the availability of new, additional, 
or different safety information in determining 
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whether the drug is a selected drug and in deter-
mining what labeling changes are appropriate. 
‘‘(4) MAINTENANCE OF LABELING.—Nothing in 
this section shall be construed to affect the responsi-
bility of the holder of an approved application under 
section 505(j) to maintain its labeling in accordance 
with existing requirements, including subpart B of 
part 201 and sections 314.70 and 314.97 of title 21, 
Code of Federal Regulations (or any successor regu-
lations). 
‘‘(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). 
‘‘(j) REPORTS.—Not later than 4 years after the date 
of the enactment of the Making Objective Drug Evidence 
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Revisions for New Labeling Act of 2020, and every 4 years 
thereafter, the Secretary shall prepare and submit to the 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate, 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.’’. 
Passed the House of Representatives November 17, 
2020. 
Attest: 
CHERYL L. JOHNSON, 
Clerk. 
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