I 
115TH CONGRESS 
1ST SESSION H. R. 2026 
To improve patient access to emerging medication therapies by clarifying 
the scope of permitted health care economic and scientific information 
communications between biopharmaceutical manufacturers and popu-
lation health decision makers. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 6, 2017 
Mr. GUTHRIE introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To improve patient access to emerging medication therapies 
by clarifying the scope of permitted health care economic 
and scientific information communications between bio-
pharmaceutical manufacturers and population health de-
cision makers. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Pharmaceutical Infor-
mation Exchange Act’’. 
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SEC. 2. FACILITATING EXCHANGE OF INFORMATION PRIOR 
TO APPROVAL. 
Section 502(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352(a)) is amended— 
(1) by redesignating subparagraph (2) as sub-
paragraph (3); 
(2) by inserting after subparagraph (1) the fol-
lowing: 
‘‘(2) Health care economic information or scientific 
information provided to a payor, formulary committee, or 
other similar entity with knowledge and expertise in the 
area of health care economic analysis carrying out its re-
sponsibilities for the selection of drugs for coverage, reim-
bursement, or other population-based health care manage-
ment, shall not be considered false or misleading or any 
other form of misbranding under this paragraph, or a vio-
lation of section 505 of this Act or section 351 of the Pub-
lic Health Service Act, or otherwise prohibited pre-ap-
proval promotion of a drug, if it is based on competent 
and reliable scientific evidence and relates to an investiga-
tional new drug or an investigational use of an approved 
drug. In order for information relating to an investiga-
tional use of an approved drug to be provided pursuant 
to this subparagraph, there must have been submitted to 
the Secretary a supplemental application for approval of 
such use, or the study or studies needed to support the 
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submission of a supplemental application for such use 
must have been completed with the intention that a sup-
plemental application will be submitted to the Secretary 
for approval of the use. For purposes of this subpara-
graph, scientific information includes clinical and pre-clin-
ical data and results relating to an unapproved drug ther-
apy, or drug indication, or other condition of use being 
investigated or developed.’’; and 
(3) in subparagraph (3), as redesignated— 
(A) by striking ‘‘(A)’’; and 
(B) by striking clause (B). 
Æ 
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