I 
115TH CONGRESS 
1ST SESSION H. R. 1703 
To amend the Federal Food, Drug, and Cosmetic Act with respect to 
determining the intended use of drugs and devices. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 23, 2017 
Mr. GRIFFITH 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 determining the intended use of drugs and devices. 
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 ‘‘Medical Product Com-
munications Act of 2017’’. 
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SEC. 2. COMMUNICATIONS REGARDING INTENDED USES OF 
DRUGS 
AND 
DEVICES; 
SCIENTIFIC 
EX-
CHANGE. 
The Federal Food, Drug, and Cosmetic Act is amend-
ed by inserting after section 201 of such Act (21 U.S.C. 
321) the following: 
‘‘SEC. 201A. INTENDED USES OF DRUGS AND DEVICES. 
‘‘(a) INTENDED USE.—For purposes of this Act, in-
cluding sections 301(d), 502(f)(1), 505, 510, and 515 and 
for purposes of section 351 of the Public Health Service 
Act, the intended use of a drug, biological product, or de-
vice— 
‘‘(1) shall be determined by reference to the ob-
jective intent of the manufacturer and sponsor of 
such drug, biological product, or device, or persons 
acting on the manufacturer’s or sponsor’s behalf, as 
demonstrated by statements contained in labeling, 
advertising, or analogous oral statements; and 
‘‘(2) shall not be determined by reference to— 
‘‘(A) actual or constructive knowledge of 
the manufacturer or sponsor that such drug, bi-
ological product, or device will be used in a 
manner that varies from the use approved for 
marketing under section 505, 510, or 515 of 
this Act or section 351 of the Public Health 
Service Act; or 
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‘‘(3) SCIENTIFIC EXCHANGE DESCRIBED.—The 
scientific exchange of information under paragraph 
(2) may include— 
‘‘(A) dissemination of scientific findings in 
scientific or lay media; 
‘‘(B) publication of results of scientific 
studies; 
‘‘(C) letters to the editor in defense of pub-
lic challenges; 
‘‘(D) communications at scientific or med-
ical conferences or meetings; 
‘‘(E) dissemination of medical or scientific 
publications, reference texts, or clinical practice 
guidelines; 
‘‘(F) communication, both proactive and 
reactive, of information regarding a manufac-
turer’s research and development efforts; 
‘‘(G) communication, both proactive and 
reactive, of scientific, medical, or technical in-
formation or findings, including communication 
of such information by personnel in scientific, 
medical, or clinical development departments of 
manufacturers; and 
‘‘(H) communication, both proactive and 
reactive, of health care economic and health 
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outcomes information, including communication 
of such information delivered by or on behalf of 
the health care economic or health outcomes de-
partments of manufacturers to an individual, 
group of individuals, or entity responsible for 
contributing toward, advising, or facilitating de-
cisionmaking related to health care resource or 
utilization management, including decisions 
about the selection of drugs, biological products, 
or devices for a population of patients. 
‘‘(4) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed— 
‘‘(A) to authorize the Secretary to require 
that a manufacturer or sponsor submit an ap-
plication, certification, or other such submis-
sion, or to seek the Secretary’s review or ap-
proval, before, during, or subsequent to engag-
ing in scientific exchange; or 
‘‘(B) to limit the ability of manufacturers 
or sponsors to engage in communications or ac-
tivities that properly constitute scientific ex-
change as that term is described in paragraph 
(2) but that are not specified in paragraph 
(3).’’. 
Æ 
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