IIB 
115TH CONGRESS 
2D SESSION 
H. R. 5811 
IN THE SENATE OF THE UNITED STATES 
JUNE 20, 2018 
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 with 
respect to postapproval study requirements for certain 
controlled substances, 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. POSTAPPROVAL STUDY REQUIREMENTS. 
(a) PURPOSES OF STUDY.—Section 505(o)(3)(B) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(o)(3)(B)) is amended by adding at the end the fol-
lowing: 
‘‘(iv) To assess a potential reduction 
in effectiveness of the drug for the condi-
tions of use prescribed, recommended, or 
suggested in the labeling thereof if— 
‘‘(I) the drug involved— 
‘‘(aa) is or contains a sub-
stance for which a listing in any 
schedule is in effect (on a tem-
porary or permanent basis) under 
section 201 of the Controlled 
Substances Act; or 
‘‘(bb) is a drug that has not 
been approved under this section 
or licensed under section 351 of 
the Public Health Service Act, 
for which an application for such 
approval or licensure is pending 
or anticipated, and for which the 
Secretary provides notice to the 
sponsor that the Secretary in-
tends to issue a scientific and 
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medical 
evaluation 
and 
rec-
ommend controls under the Con-
trolled Substances Act; and 
‘‘(II) the potential reduction in 
effectiveness could result in the bene-
fits of the drug no longer outweighing 
the risks.’’. 
(b) ESTABLISHMENT
OF REQUIREMENT.—Section 
505(o)(3)(C) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(o)(3)(C)) is amended by striking 
‘‘such requirement’’ and all that follows through ‘‘safety 
information.’’ and inserting the following: ‘‘such require-
ment— 
‘‘(i) in the case of a purpose described 
in clause (i), (ii), or (iii) of subparagraph 
(B), only if the Secretary becomes aware of 
new safety information; and 
‘‘(ii) in the case of a purpose de-
scribed in clause (iv) of such subpara-
graph, if the Secretary determines that 
new effectiveness information exists.’’. 
(c) APPLICABILITY.—Section 505(o)(3) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)) 
is amended by adding at the end the following new sub-
paragraph: 
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‘‘(G) APPLICABILITY.—The conduct of a 
study or clinical trial required pursuant to this 
paragraph for the purpose specified in subpara-
graph (B)(iv) shall not be considered a new 
clinical investigation for the purpose of a period 
of exclusivity under clause (iii) or (iv) of sub-
section (c)(3)(E) or clause (iii) or (iv) of sub-
section (j)(5)(F).’’. 
(d) 
NEW
EFFECTIVENESS
INFORMATION
DE-
FINED.—Section 505(o)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(o)(2)) is amended by 
adding at the end the following new subparagraph: 
‘‘(D) 
NEW
EFFECTIVENESS
INFORMA-
TION.—The term ‘new effectiveness informa-
tion’, with respect to a drug that is or contains 
a controlled substance for which a listing in any 
schedule is in effect (on a temporary or perma-
nent basis) under section 201 of the Controlled 
Substances Act, means new information about 
the effectiveness of the drug, including a new 
analysis of existing information, derived from— 
‘‘(i) a clinical trial; an adverse event 
report; a postapproval study or clinical 
trial (including a study or clinical trial 
under paragraph (3)); 
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‘‘(ii) 
peer-reviewed 
biomedical 
lit-
erature; 
‘‘(iii) 
data 
derived 
from 
the 
postmarket risk identification and analysis 
system under subsection (k); or 
‘‘(iv) other scientific data determined 
to be appropriate by the Secretary.’’. 
(e) CONFORMING AMENDMENTS WITH RESPECT TO 
LABELING CHANGES.—Section 505(o)(4) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(4)) is 
amended— 
(1) in subparagraph (A)— 
(A) in the heading, by inserting ‘‘OR NEW 
EFFECTIVENESS’’ after ‘‘SAFETY’’; 
(B) by striking ‘‘safety information’’ and 
inserting ‘‘new safety information or new effec-
tiveness information such’’; and 
(C) by striking ‘‘believes should be’’ and 
inserting ‘‘believes changes should be made to’’; 
(2) in subparagraph (B)(i)— 
(A) by striking ‘‘new safety information’’ 
and by inserting ‘‘new safety information or 
new effectiveness information’’; and 
(B) 
by 
inserting 
‘‘indications,’’ 
after 
‘‘boxed warnings,’’; 
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(3) in subparagraph (C), by inserting ‘‘or new 
effectiveness information’’ after ‘‘safety informa-
tion’’; and 
(4) in subparagraph (E), by inserting ‘‘or new 
effectiveness information’’ after ‘‘safety informa-
tion’’. 
(f) RULE
OF
CONSTRUCTION.—Nothing in the 
amendments made by this section shall be construed to 
alter, in any manner, the meaning or application of the 
provisions of paragraph (3) of section 505(o) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)) 
with respect to the authority of the Secretary of Health 
and Human Services to require a postapproval study or 
clinical trial for a purpose specified in clauses (i) through 
(iii) of subparagraph (B) of such paragraph (3) or para-
graph (4) of such section 505(o) with respect to the Sec-
retary’s authority to require safety labeling changes. 
Passed the House of Representatives June 19, 2018. 
Attest: 
KAREN L. HAAS, 
Clerk. 
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