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States through review and analysis of Internet 
websites, import data, and other sources of intel-
ligence for purposes of making the best use of the 
Food and Drug Administration’s inspection and ana-
lytical resources. 
‘‘(4) Increasing the number of staff of the Food 
and Drug Administration to increase the number of 
packages being examined, ensuring the safety of the 
staff undertaking such examinations, and ensuring 
that packages identified as illegal, counterfeit, mis-
branded, or adulterated are removed from commerce 
through available authorities, including administra-
tive destruction. 
‘‘(5) Enhancing the Food and Drug Adminis-
tration’s criminal investigations resources (including 
full-time equivalent employees and equipment), im-
ports surveillance, and international work. 
‘‘(6) Obtaining for the Food and Drug Admin-
istration equipment and full-time equivalent employ-
ees needed to efficiently screen and analyze products 
offered for import, including by building data librar-
ies of new substances and analogues to facilitate 
identification and evaluation of pharmaceutical- 
based agents and by purchasing screening tech-
nologies for use at international mail facilities. 
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‘‘(7) Operating the Food and Drug Administra-
tion’s forensic laboratory facility to ensure adequate 
laboratory space and functionality for additional 
work and full-time equivalent employees. 
‘‘(e) ACCOUNTABILITY AND OVERSIGHT.— 
‘‘(1) WORK PLAN.— 
‘‘(A) IN
GENERAL.—Not later than 180 
days after the date of enactment of this Act, 
the Commissioner of Food and Drugs shall sub-
mit 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 work plan includ-
ing the proposed allocation of funds appro-
priated pursuant to the authorization of appro-
priations under subsection (c) for each of fiscal 
years 2019 through 2023 and the contents de-
scribed in subparagraph (B). 
‘‘(B) CONTENTS.—The work plan sub-
mitted under subparagraph (A) shall include— 
‘‘(i) the amount of money to be obli-
gated or expended out of the Fund in each 
fiscal year for each program and activity 
described in subsection (d); and 
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‘‘(ii) a description and justification of 
each such program and activity. 
‘‘(2) REPORTS.— 
‘‘(A) ANNUAL REPORTS.—Not later than 
October 1 of each of fiscal years 2020 through 
2024, the Secretary of Health and Human 
Services shall submit to the Committee on 
Health, Education, Labor and Pensions of the 
Senate and the Committee on Energy and Com-
merce of the House of Representatives a report 
that includes— 
‘‘(i) the amount of money obligated or 
expended out of the Fund in the prior fis-
cal year for each program and activity de-
scribed in subsection (d); 
‘‘(ii) a description of all programs and 
activities using funds provided pursuant to 
the authorization of appropriations under 
subsection (c); and 
‘‘(iii) how the programs and activities 
are advancing public health. 
‘‘(B) ADDITIONAL REPORTS.—At the re-
quest of the Committee on Health, Education, 
Labor and Pensions of the Senate or the Com-
mittee on Energy and Commerce of the House 
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of Representatives, the Commissioner shall pro-
vide an update in the form of testimony and 
any additional reports to the respective congres-
sional committee regarding the allocation of 
funding under this section or the description of 
the programs and activities undertaken with 
such funding. 
‘‘(f) LIMITATIONS.—Notwithstanding any transfer 
authority authorized by this section or any appropriations 
Act, any funds made available pursuant to the authoriza-
tion of appropriations under subsection (c) may not be 
used for any purpose other than the programs and activi-
ties described in subsection (d) to strengthen and facilitate 
the Food and Drug Administration’s efforts to address the 
opioid and substance use epidemic. 
‘‘(g) SUNSET.—This section shall expire on Sep-
tember 30, 2022, except that— 
‘‘(1) this subsection does not apply to reporting 
under subsection (e)(2); and 
‘‘(2) this section shall remain in effect until 
such time, and to such extent, as may be necessary 
for the funds transferred by subsection (b)(2) to be 
fully expended.’’. 
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SEC. 6. CONSIDERATION OF POTENTIAL FOR MISUSE AND 
ABUSE REQUIRED FOR DRUG APPROVAL. 
(a) IN GENERAL.—Section 505(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) is 
amended— 
(1) in the first sentence— 
(A) by striking ‘‘or (7)’’ and inserting 
‘‘(7)’’; and 
(B) by inserting ‘‘or (8) if the drug is or 
contains a controlled substance for which a list-
ing in any schedule is in effect under the Con-
trolled Substances Act or that is permanently 
scheduled pursuant to section 201 of such Act, 
on the basis of information submitted to him as 
part of the application, or upon the basis of any 
other information before him with respect to 
such drug, the drug is unsafe for use due to the 
risks of abuse or misuse or there is insufficient 
information to show that the drug is safe for 
use considering such risks;’’ before ‘‘he shall 
issue an order refusing to approve the applica-
tion’’; and 
(2) in the second sentence, by striking ‘‘(6)’’ 
and inserting ‘‘(8)’’. 
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(b) WITHDRAWAL AUTHORITY.—Section 505(e) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(e)) is amended in the first sentence— 
(1) by striking ‘‘or (5)’’ and inserting ‘‘(5)’’; 
and 
(2) by inserting the following: ‘‘; or (6) that, in 
the case of a drug that is or contains a controlled 
substance for which a listing in any schedule is in 
effect under the Controlled Substances Act or that 
is permanently scheduled pursuant to section 201 of 
such Act, on the basis of new information before him 
with respect to such drug, evaluated together with 
the information available to him when the applica-
tion was approved, that the drug is unsafe for use 
due to the risks of abuse or misuse’’ after ‘‘of a ma-
terial fact’’. 
(c) RULE
OF
CONSTRUCTION.—Nothing in the 
amendments made by this section shall be construed to 
limit or narrow, in any manner, the meaning or applica-
tion of the provisions of paragraphs (1), (2), (3), (4), (5), 
and (7) of section 505(d) of the Federal Food, Drug, and 
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