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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘21st Century Tools 

5 for Pain and Addiction Treatment Act’’. 

6 SEC. 2. CLARIFYING FDA REGULATION OF NON-ADDICTIVE 

7 PAIN AND ADDICTION THERAPIES. 

8 (a) PUBLIC MEETINGS.—Not later than 1 year after 

9 the date of enactment of this Act, the Secretary of Health 


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1 and Human Services, acting through the Commissioner of 

2 Food and Drugs, shall hold not less than one public meet3 ing to address the challenges and barriers of developing 

4 non-addictive medical products intended to treat pain or 

5 addiction, which may include— 

6 (1) the application of novel clinical trial designs 

7 (consistent with section 3021 of the 21st Century 

8 Cures Act (Public Law 114–255)), use of real world 

9 evidence (consistent with section 505F of the Fed10 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

11 355g)), and use of patient experience data (con12 sistent with section 569C of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c)) for 

14 the development of non-addictive medical products 

15 intended to treat pain or addiction; and 

16 (2) the application of eligibility criteria under 

17 sections 506 and 515B of the Federal Food, Drug, 

18 and Cosmetic Act (21 U.S.C. 356, 360e–3) for non19 addictive medical products intended to treat pain or 

20 addiction. 

21 (b) GUIDANCE.—Not later than one year after the 

22 public meetings are conducted under subsection (a) the 

23 Secretary shall issue one or more final guidance docu24 ments, or update existing guidance documents, to help ad25 dress challenges to developing non-addictive medical prodVerDate Sep 11 2014 23:26 May 30, 2018 Jkt 079200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5806.IH H5806

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1 ucts to treat pain or addiction. Such guidance documents 

2 shall include information regarding— 

3 (1) how the Food and Drug Administration 

4 may apply sections 506 and 515B of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 356, 

6 360e–3) to non-addictive medical products intended 

7 to treat pain or addiction, including the cir8 cumstances under which the Secretary— 

9 (A) may apply the eligibility criteria under 

10 such sections 506 and 515B to non-opioid or 

11 non-addictive medical products intended to 

12 treat pain or addiction; 

13 (B) considers the risk of addiction of con14 trolled substances approved to treat pain when 

15 establishing unmet medical need; and 

16 (C) considers pain, pain control, or pain 

17 management in assessing whether a disease or 

18 condition is a serious or life-threatening disease 

19 or condition; and 

20 (2) the methods by which sponsors may evalu21 ate acute and chronic pain, endpoints for non-addict22 ive medical products intended to treat pain, the 

23 manner in which endpoints and evaluations of effi24 cacy will be applied across and within review divi25 sions, taking into consideration the etiology of the 


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1 underlying disease, and the manner in which spon2 sors may use surrogate endpoints, intermediate 

3 endpoints, and real world evidence. 

4 (c) MEDICAL PRODUCT DEFINED.—In this section, 

5 the term ‘‘medical product’’ means a drug (as defined in 

6 section 201(g)(1) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 321(g)(1))), biological product (as 

8 defined in section 351(i) of the Public Health Service Act 

9 (42 U.S.C. 262(i))), or device (as defined in section 

10 201(h) of the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 321(h))). 

Æ 


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