II 

115TH CONGRESS 

2D SESSION S. 2669 

To provide for accelerated approval of pain and addiction therapies. 

IN THE SENATE OF THE UNITED STATES 

APRIL 16, 2018 

Mr. HATCH (for himself, Mr. BENNET, Mr. DONNELLY, and Mr. YOUNG) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide for accelerated approval of pain and addiction 

therapies. 

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 ‘‘Advancing Innovation 

5 in Alternative Pain and Addiction Therapies Act’’. 

6 SEC. 2. ACCELERATED APPROVAL OF PAIN AND ADDICTION 

7 THERAPIES. 

8 (a) PURPOSE.—It is the purpose of this section to 

9 clarify the appropriate processes for encouraging and ex10 pediting the review of non-opioid or non-addictive medical 


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1 products to treat chronic or acute pain or substance use 

2 disorders. 

3 (b) DRAFT GUIDANCE.— 

4 (1) IN GENERAL.—Not later than 1 year after 

5 the date of enactment of this Act, the Secretary of 

6 Health and Human Services (referred to in this sec7 tion as the ‘‘Secretary’’), acting through the Com8 missioner of Food and Drugs, shall issue draft guid9 ance, clarifying the methods and processes by which 

10 the Food and Drug Administration may provide ac11 celerated approval for non-opioid or non-addictive 

12 drugs developed to treat chronic or acute pain or 

13 substance use disorders. 

14 (2) CONTENTS.—The guidance under para15 graph (1) shall address— 

16 (A) eligibility requirements for such drugs 

17 to receive accelerated approval; 

18 (B) opportunities for engagement with the 

19 Food and Drug Administration with respect to 

20 the accelerated approval pathway; 

21 (C) considerations for different types of 

22 pain and product mechanism of action; and 

23 (D) potential criteria for novel surrogate or 

24 intermediate clinical endpoints or biomarkers to 

25 assess pain. 


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1 (c) FINAL GUIDANCE.—Not later than 6 months 

2 after the close of the period for public comment on the 

3 draft guidance under subsection (b), the Secretary shall 

4 finalize such guidance. 

5 (d) DATA IN PERFORMANCE REPORTS.— 

6 (1) IN GENERAL.—As a component of the an7 nual performance report under section 736B(a) of 

8 the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 379h–2(a)), the Secretary shall include infor10 mation, as appropriate, on policies and processes of 

11 the Division of Anesthesia, Analgesia, and Addiction 

12 Products of the Food and Drug Administration (re13 ferred to in this section as the ‘‘DAAAP’’) for the 

14 accelerated approval pathway with respect to drugs 

15 developed to treat pain or substance use disorders, 

16 during the previous fiscal year. 

17 (2) CONTENTS.—Information submitted as a 

18 part of the performance reports under section 

19 736B(a) of the Federal Food, Drug, and Cosmetic 

20 Act may address— 

21 (A) the number of requests for accelerated 

22 approval submitted to the DAAAP for non23 opioid or non-addictive medical products; 

24 (B) the number of applications for acceler25 ated approval that the DAAAP granted, and a 


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1 description of the common reasons for granting 

2 applications for accelerated approval; 

3 (C) the number of applications for acceler4 ated approval that the DAAAP denied, and a 

5 description of the common reasons for denying 

6 applications for accelerated approval; 

7 (D) the percentage of products in such re8 view division which met the review goals identi9 fied in the letters described in section 101(b) of 

10 the Prescription Drug User Fee Amendments 

11 of 2017 (Public Law 115–52); 

12 (E) agency efforts to ensure consistency 

13 across review divisions in the metrics and proc14 esses by which new drug applications for non15 addictive or non-opioid products intended to 

16 treat pain are reviewed; 

17 (F) a discussion and summary of the com18 mon reasons for applications which did not 

19 meet the review goals identified in the letters 

20 described in section 101(b) of the Prescription 

21 Drug User Fee Amendments of 2017 (Public 

22 Law 115–52), as applicable and appropriate; 

23 and 

24 (G) recommendations to better enable utili25 zation of the accelerated approval pathway. 


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1 SEC. 3. BREAKTHROUGH THERAPY STATUS FOR PAIN AND 

2 ADDICTION THERAPIES. 

3 (a) DRAFT GUIDANCE.— 

4 (1) IN GENERAL.—Not later than 1 year after 

5 the date of enactment of this Act, the Secretary of 

6 Health and Human Services (referred to in this sec7 tion as the ‘‘Secretary’’), acting through the Com8 missioner of Food and Drugs, shall issue draft guid9 ance, clarifying the methods and processes by which 

10 the Food and Drug Administration may provide a 

11 breakthrough therapy designation for non-opioid or 

12 non-addictive drugs or devices developed to treat 

13 chronic or acute pain or substance use disorders. 

14 (2) CONTENTS.—The guidance under para15 graph (1) shall address— 

16 (A) eligibility requirements for such drugs 

17 and devices to receive breakthrough therapy 

18 designation; 

19 (B) opportunities for engagement with the 

20 Food and Drug Administration with respect to 

21 the breakthrough therapy pathway; 

22 (C) specific actions to ensure that the de23 sign of the clinical trials is as efficient as prac24 ticable, when applicable and scientifically appro25 priate, for such drugs and devices; and 


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1 (D) the application of organizational com2 mitment of the Food and Drug Administration 

3 to facilitating breakthrough designation for 

4 qualified drugs and devices, including involve5 ment of senior managers of the Food and Drug 

6 Administration for such drugs and devices. 

7 (b) FINAL GUIDANCE.—Not later than 6 months 

8 after the close of the period for public comment on the 

9 draft guidance under subsection (a), the Secretary shall 

10 finalize such guidance. 

11 (c) DATA IN PERFORMANCE REPORTS.— 

12 (1) IN GENERAL.—As a component of the per13 formance reports under sections 736B(a) and 

14 738A(a) of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 379h–2, 379j–1), the Secretary shall 

16 include information, as appropriate, on policies and 

17 processes of the Division of Anesthesia, Analgesia, 

18 and Addiction Products of the Food and Drug Ad19 ministration (referred to in this section as the 

20 ‘‘DAAAP’’) for the breakthrough therapy pathway, 

21 with respect to drugs and devices developed to treat 

22 chronic or acute pain or substance use disorders, 

23 during the previous fiscal year. 

24 (2) CONTENTS.—Information provided as a 

25 component of the performance reports under secVerDate Sep 11 2014 03:29 Apr 19, 2018 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2669.IS S2669

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1 tions 736B(a) and 738A(a) of the Federal Food, 

2 Drug, and Cosmetic Act may address— 

3 (A) the number of requests for break4 through therapy designation submitted to the 

5 DAAAP; 

6 (B) the number of applications for break7 through therapy designation that the DAAAP 

8 granted, and a description of the common rea9 sons for granting applications for breakthrough 

10 therapy designation; 

11 (C) the number of applications for break12 through therapy designation that the DAAAP 

13 denied, and a description of the common rea14 sons for denying applications for breakthrough 

15 therapy designation; and 

16 (D) recommendations to better enable uti17 lization of the breakthrough therapy designa18 tion pathway for non-addictive or non-opioid 

19 products intended to treat pain. 

Æ 


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