I 
115TH CONGRESS 
2D SESSION 
H. R. 5806 
To require the Secretary of Health and Human Services to issue guidance 
with respect to the expedited approval of certain drugs, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 15, 2018 
Mr. BURGESS (for himself, Mr. BUCSHON, and Mr. GRIFFITH) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To require the Secretary of Health and Human Services 
to issue guidance with respect to the expedited approval 
of certain 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, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘21st Century Tools 
for Pain and Addiction Treatment Act’’. 
SEC. 2. CLARIFYING FDA REGULATION OF NON-ADDICTIVE 
PAIN AND ADDICTION THERAPIES. 
(a) PUBLIC MEETINGS.—Not later than 1 year after 
the date of enactment of this Act, the Secretary of Health 
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and Human Services, acting through the Commissioner of 
Food and Drugs, shall hold not less than one public meet-
ing to address the challenges and barriers of developing 
non-addictive medical products intended to treat pain or 
addiction, which may include— 
(1) the application of novel clinical trial designs 
(consistent with section 3021 of the 21st Century 
Cures Act (Public Law 114–255)), use of real world 
evidence (consistent with section 505F of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355g)), and use of patient experience data (con-
sistent with section 569C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c)) for 
the development of non-addictive medical products 
intended to treat pain or addiction; and 
(2) the application of eligibility criteria under 
sections 506 and 515B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356, 360e–3) for non- 
addictive medical products intended to treat pain or 
addiction. 
(b) GUIDANCE.—Not later than one year after the 
public meetings are conducted under subsection (a) the 
Secretary shall issue one or more final guidance docu-
ments, or update existing guidance documents, to help ad-
dress challenges to developing non-addictive medical prod-
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ucts to treat pain or addiction. Such guidance documents 
shall include information regarding— 
(1) how the Food and Drug Administration 
may apply sections 506 and 515B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356, 
360e–3) to non-addictive medical products intended 
to treat pain or addiction, including the cir-
cumstances under which the Secretary— 
(A) may apply the eligibility criteria under 
such sections 506 and 515B to non-opioid or 
non-addictive medical products intended to 
treat pain or addiction; 
(B) considers the risk of addiction of con-
trolled substances approved to treat pain when 
establishing unmet medical need; and 
(C) considers pain, pain control, or pain 
management in assessing whether a disease or 
condition is a serious or life-threatening disease 
or condition; and 
(2) the methods by which sponsors may evalu-
ate acute and chronic pain, endpoints for non-addict-
ive medical products intended to treat pain, the 
manner in which endpoints and evaluations of effi-
cacy will be applied across and within review divi-
sions, taking into consideration the etiology of the 
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underlying disease, and the manner in which spon-
sors may use surrogate endpoints, intermediate 
endpoints, and real world evidence. 
(c) MEDICAL PRODUCT DEFINED.—In this section, 
the term ‘‘medical product’’ means a drug (as defined in 
section 201(g)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(g)(1))), biological product (as 
defined in section 351(i) of the Public Health Service Act 
(42 U.S.C. 262(i))), or device (as defined in section 
201(h) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(h))). 
Æ 
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