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 eco-
nomic information. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. FACILITATING DISSEMINATION OF HEALTH 
CARE ECONOMIC INFORMATION. 
Section 502(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352(a)) is amended— 
(1) by striking ‘‘(a) If its’’ and inserting 
‘‘(a)(1) If its’’; 
(2) by striking ‘‘a formulary committee, or 
other similar entity, in the course of the committee 
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or the entity carrying out its responsibilities for the 
selection of drugs for managed care or other similar 
organizations’’ and inserting ‘‘a payor, formulary 
committee, or other similar entity with knowledge 
and expertise in the area of health care economic 
analysis, carrying out its responsibilities for the se-
lection of drugs for coverage or reimbursement’’; 
(3) by striking ‘‘directly relates’’ and inserting 
‘‘relates’’; 
(4) by striking ‘‘and is based on competent and 
reliable scientific evidence. The requirements set 
forth in section 505(a) or in section 351(a) of the 
Public Health Service Act shall not apply to health 
care economic information provided to such a com-
mittee or entity in accordance with this paragraph’’ 
and inserting ‘‘, is based on competent and reliable 
scientific evidence, and includes, where applicable, a 
conspicuous and prominent statement describing any 
material differences between the health care eco-
nomic information and the labeling approved for the 
drug under section 505 or under section 351 of the 
Public Health Service Act. The requirements set 
forth in section 505(a) or in subsections (a) and (k) 
of section 351 of the Public Health Service Act shall 
not apply to health care economic information pro-
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vided to such a payor, committee, or entity in ac-
cordance with this paragraph’’; and 
(5) by striking ‘‘In this paragraph, the term’’ 
and all that follows and inserting the following: 
‘‘(2)(A) For purposes of this paragraph, the term 
‘health care economic information’ means any analysis (in-
cluding the clinical data, inputs, clinical or other assump-
tions, methods, results, and other components underlying 
or comprising the analysis) that identifies, measures, or 
describes the economic consequences, which may be based 
on the separate or aggregated clinical consequences of the 
represented health outcomes, of the use of a drug. Such 
analyses may be comparative to the use of another drug, 
to another health care intervention, or to no intervention. 
‘‘(B) Such term does not include any analysis that 
relates only to an indication that is not approved under 
section 505 or under section 351 of the Public Health 
Service Act for such drug.’’. 
Æ 
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