IB 
Union Calendar No. 471 
116TH CONGRESS 
2D SESSION 
H. R. 5668 
[Report No. 116–573] 
To amend the Federal Food, Drug, and Cosmetic Act to modernize the 
labeling of certain generic drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 24, 2020 
Ms. MATSUI (for herself and Mr. GUTHRIE) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
NOVEMBER 16, 2020 
Additional sponsor: Mr. TAYLOR 
NOVEMBER 16, 2020 
Reported with an amendment; committed to the Committee of the Whole 
House on the State of the Union and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on January 24, 2020] 
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A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
modernize the labeling of certain generic drugs, and for 
other purposes. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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tion has been withdrawn for reasons other than 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-
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tions of use that is not reflected in the label-
ing; 
‘‘(II) the approved labeling does not re-
flect current legal and regulatory require-
ments 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 respect 
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 sec-
tion 505(j)(5)(F), or section 505A, 505E, or 527. 
‘‘(3) The term ‘generic version’ means a drug ap-
proved 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 through 
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the process under subsection (c) that the labeling 
should be changed. 
‘‘(b) IDENTIFICATION OF COVERED DRUGS.—The Sec-
retary may identify covered drugs for which labeling up-
dates 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 accept-
ed use in clinical practice that is not reflected in the 
approved labeling of such drugs or whether new sci-
entific evidence is available regarding the conditions 
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 la-
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beling or providing supplemental information to the label-
ing 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 appro-
priate for a selected drug pursuant to subsection (c), the 
Secretary shall provide notice to the holders of approved 
applications for a generic version of such drug that— 
‘‘(1) summarizes the findings supporting the de-
termination of the Secretary that the available sci-
entific evidence meets the standards under section 505 
for adding or modifying information or providing 
supplemental information to the labeling of the cov-
ered drug pursuant to subsection (c); 
‘‘(2) provides a clear statement regarding the ad-
ditional, 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 pursuant 
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to subsection (d), the holder of an approved application for 
a generic version of the selected drug shall— 
‘‘(1) agree to change the approved labeling to re-
flect the additional, modified, or supplemental infor-
mation 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 applica-
tion holder’s response, the Secretary shall promptly 
review each statement received under subsection (e)(2) 
and determine which labeling changes pursuant to the 
Secretary’s notice under subsection (d) are appro-
priate, if any. If the Secretary disagrees with the rea-
sons 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. 
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‘‘(2) CHANGES TO LABELING.—After considering 
all responses from the holder of an approved applica-
tion under paragraph (1) or (2) of subsection (e), and 
any discussion under paragraph (1), the Secretary 
may order such holder to make the labeling changes 
the Secretary determines are appropriate. 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 Effected’. 
‘‘(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 ge-
neric version of the selected drug shall be deemed to be mis-
branded under section 502. 
‘‘(h) LIMITATIONS; GENERIC DRUGS.— 
‘‘(1) IN GENERAL.—With respect to any labeling 
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 
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