I 
116TH CONGRESS 
2D SESSION 
H. R. 5632 
To establish procedures regarding the approval of opioid drugs by the Food 
and Drug Administration. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 16, 2020 
Mr. KIM introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
A BILL 
To establish procedures regarding the approval of opioid 
drugs by the Food and Drug Administration. 
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 ‘‘FDA Accountability 
for Public Safety Act’’. 
SEC. 2. APPROVAL AGAINST THE RECOMMENDATION OF 
THE FDA ADVISORY COMMITTEE ON OPIOID 
DRUGS. 
(a) IN GENERAL.—Any approval of an application or 
supplement to an application under section 505(b) of the 
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 
for a drug that is an opioid against the recommendation 
of the advisory committee pursuant to section 106 of the 
Comprehensive Drug and Recovery Act of 2016 (Public 
Law 114–198) shall be made by the Commissioner of 
Food and Drugs (referred to in this section as the ‘‘Com-
missioner’’) and shall not be delegated. 
(b) REPORTS TO CONGRESS.—If the Commissioner 
approves a drug as described in subsection (a), the Com-
missioner shall— 
(1) submit a report to the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate and the Committee on Energy and Commerce of 
the House of Representatives, and to any member of 
Congress that requests the report, that includes— 
(A) medical and scientific evidence regard-
ing patient safety that clearly supports the 
Commissioner’s decision to approve the opioid 
drug against the recommendation of the advi-
sory committee; and 
(B) a disclosure of any potential conflicts 
of interest that may exist regarding any official 
of the Food and Drug Administration who was 
involved in the decision to approve the drug 
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prior to the Commissioner’s final decision under 
subsection (a); and 
(2) at the request of the Committee on Health, 
Education, Labor, and Pensions of the Senate or the 
Committee on Energy and Commerce of the House 
of Representatives, testify before that committee re-
garding the Commissioner’s decision to approve the 
opioid drug against the recommendation of the advi-
sory committee. 
(c) PROHIBITION ON MARKETING.—A drug approved 
as described in subsection (a) shall not be introduced or 
delivered for introduction into interstate commerce until 
the report described in subsection (b)(1) has been sub-
mitted to Congress. 
(d) SCOPE OF ADVISORY COMMITTEE REVIEW.—Sec-
tion 106(a)(1)(A) of the Comprehensive Addiction and Re-
covery Act of 2016 (Public Law 114–198) is amended— 
(1) by inserting ‘‘, or supplement to an applica-
tion,’’ after ‘‘application’’ each place such term ap-
pears; and 
(2) by striking ‘‘of a new’’ and inserting ‘‘for’’. 
Æ 
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