I 

114TH CONGRESS 

1ST SESSION H. R. 2416 

To amend the Federal Food, Drug, and Cosmetic Act to evaluate the potential 

use of evidence from clinical experience to help support the approval 

of new indications for approved drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 19, 2015 

Mr. BURGESS introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

evaluate the potential use of evidence from clinical experience to help support the approval of new indications 

for approved 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. UTILIZING EVIDENCE FROM CLINICAL EXPERI4 ENCE. 

5 Chapter V of the Federal Food, Drug, and Cosmetic 

6 Act is amended by inserting after section 505E of such 

7 Act (21 U.S.C. 355f) the following: 


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1 ‘‘SEC. 505F. UTILIZING EVIDENCE FROM CLINICAL EXPERI2 ENCE. 

3 ‘‘(a) IN GENERAL.—The Secretary shall establish a 

4 program to evaluate the potential use of evidence from 

5 clinical experience— 

6 ‘‘(1) to help support the approval of a new indi7 cation for a drug approved under section 505(b); 

8 and 

9 ‘‘(2) to help support or satisfy post-approval 

10 study requirements. 

11 ‘‘(b) EVIDENCE FROM CLINICAL EXPERIENCE DE12 FINED.—In this section, the term ‘evidence from clinical 

13 experience’ means data regarding the usage, or potential 

14 benefits or risks, of a drug derived from sources other 

15 than randomized clinical trials, including from observa16 tional studies, registries, and therapeutic use. 

17 ‘‘(c) PROGRAM FRAMEWORK.— 

18 ‘‘(1) IN GENERAL.—Not later than 18 months 

19 after the date of enactment of this section, the Sec20 retary shall establish a draft framework for imple21 mentation of the program under this section. 

22 ‘‘(2) CONTENTS OF FRAMEWORK.—The frame23 work shall include information describing— 

24 ‘‘(A) the current sources of data developed 

25 through clinical experience, including ongoing 


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1 safety surveillance, registry, claims, and pa2 tient-centered outcomes research activities; 

3 ‘‘(B) the gaps in current data collection ac4 tivities; 

5 ‘‘(C) the current standards and methodolo6 gies for collection and analysis of data gen7 erated through clinical experience; and 

8 ‘‘(D) the priority areas, remaining chal9 lenges, and potential pilot opportunities that 

10 the program established under this section will 

11 address. 

12 ‘‘(3) CONSULTATION.— 

13 ‘‘(A) IN GENERAL.—In developing the pro14 gram framework under this subsection, the Sec15 retary shall consult with regulated industry, 

16 academia, medical professional organizations, 

17 representatives of patient advocacy organiza18 tions, disease research foundations, and other 

19 interested parties. 

20 ‘‘(B) PROCESS.—The consultation under 

21 subparagraph (A) may be carried out through 

22 approaches such as— 

23 ‘‘(i) a public-private partnership with 

24 the entities described in such subparaVerDate Sep 11 2014 02:15 May 27, 2015 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2416.IH H2416

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1 graph, in which the Secretary may partici2 pate; or 

3 ‘‘(ii) a contract, grant, or other ar4 rangement, as determined appropriate by 

5 the Secretary with such a partnership or 

6 an independent research organization. 

7 ‘‘(d) PROGRAM IMPLEMENTATION.—The Secretary 

8 shall, not later than 24 months after the date of enact9 ment of this section and in accordance with the framework 

10 established under subsection (c), implement the program 

11 to evaluate the potential use of evidence from clinical expe12 rience. 

13 ‘‘(e) GUIDANCE FOR INDUSTRY.—The Secretary 

14 shall— 

15 ‘‘(1) utilize the program established in sub16 section (d), its activities, and any subsequent pilots 

17 or written reports, to inform a guidance for industry 

18 on— 

19 ‘‘(A) the circumstances under which spon20 sors of drugs and the Secretary may rely on 

21 evidence from clinical experience for the pur22 poses described in subsections (a)(1) or (a)(2); 

23 and 

24 ‘‘(B) the appropriate standards and meth25 odologies for collection and analysis of evidence 


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1 from clinical experience submitted for such pur2 poses; 

3 ‘‘(2) not later than 36 months after the date of 

4 enactment of this section, issue draft guidance for 

5 industry as described in paragraph (1); and 

6 ‘‘(3) not later than 48 months after the date of 

7 enactment of this section, after providing an oppor8 tunity for public comment on the draft guidance, 

9 issue final guidance. 

10 ‘‘(f) RULE OF CONSTRUCTION.— 

11 ‘‘(1) Subject to paragraph (2), nothing in this 

12 section prohibits the Secretary from using evidence 

13 from clinical experience for purposes not specified in 

14 this section, provided the Secretary determines that 

15 sufficient basis exists for any such non-specified use. 

16 ‘‘(2) This section shall not be construed to 

17 alter— 

18 ‘‘(A) the standards of evidence under— 

19 ‘‘(i) subsection (c) or (d) of section 

20 505, including the substantial evidence 

21 standard in such subsection (d); or 

22 ‘‘(ii) section 351(a) of the Public 

23 Health Service Act; or 

24 ‘‘(B) the Secretary’s authority to require 

25 post-approval studies or clinical trials, or the 


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1 standards of evidence under which studies or 

2 trials are evaluated.’’. 

Æ 


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