I 

114TH CONGRESS 

1ST SESSION H. R. 2452 

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

facilitating dissemination of health care economic information. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 19, 2015 

Mr. LONG (for himself, Mr. SCHRADER, and 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 with 

respect to facilitating dissemination of health care economic information. 

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

3 SECTION 1. FACILITATING DISSEMINATION OF HEALTH 

4 CARE ECONOMIC INFORMATION. 

5 Section 502(a) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 352(a)) is amended— 

7 (1) by striking ‘‘(a) If its’’ and inserting 

8 ‘‘(a)(1) If its’’; 

9 (2) by striking ‘‘a formulary committee, or 

10 other similar entity, in the course of the committee 


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1 or the entity carrying out its responsibilities for the 

2 selection of drugs for managed care or other similar 

3 organizations’’ and inserting ‘‘a payor, formulary 

4 committee, or other similar entity with knowledge 

5 and expertise in the area of health care economic 

6 analysis, carrying out its responsibilities for the se7 lection of drugs for coverage or reimbursement’’; 

8 (3) by striking ‘‘directly relates’’ and inserting 

9 ‘‘relates’’; 

10 (4) by striking ‘‘and is based on competent and 

11 reliable scientific evidence. The requirements set 

12 forth in section 505(a) or in section 351(a) of the 

13 Public Health Service Act shall not apply to health 

14 care economic information provided to such a com15 mittee or entity in accordance with this paragraph’’ 

16 and inserting ‘‘, is based on competent and reliable 

17 scientific evidence, and includes, where applicable, a 

18 conspicuous and prominent statement describing any 

19 material differences between the health care eco20 nomic information and the labeling approved for the 

21 drug under section 505 or under section 351 of the 

22 Public Health Service Act. The requirements set 

23 forth in section 505(a) or in subsections (a) and (k) 

24 of section 351 of the Public Health Service Act shall 

25 not apply to health care economic information proVerDate Sep 11 2014 04:11 May 27, 2015 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2452.IH H2452

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1 vided to such a payor, committee, or entity in ac2 cordance with this paragraph’’; and 

3 (5) by striking ‘‘In this paragraph, the term’’ 

4 and all that follows and inserting the following: 

5 ‘‘(2)(A) For purposes of this paragraph, the term 

6 ‘health care economic information’ means any analysis (in7 cluding the clinical data, inputs, clinical or other assump8 tions, methods, results, and other components underlying 

9 or comprising the analysis) that identifies, measures, or 

10 describes the economic consequences, which may be based 

11 on the separate or aggregated clinical consequences of the 

12 represented health outcomes, of the use of a drug. Such 

13 analyses may be comparative to the use of another drug, 

14 to another health care intervention, or to no intervention. 

15 ‘‘(B) Such term does not include any analysis that 

16 relates only to an indication that is not approved under 

17 section 505 or under section 351 of the Public Health 

18 Service Act for such drug.’’. 

Æ 


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