I 
114TH CONGRESS 
1ST SESSION H. R. 2479 
To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
issuance of up-to-date regulations and guidance applying to the dissemi-
nation by means of the Internet of information about medical products. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 20, 2015 
Mr. LONG 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 
provide for the issuance of up-to-date regulations and 
guidance applying to the dissemination by means of the 
Internet of information about medical products. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. DISSEMINATION OF INFORMATION ABOUT 
MEDICAL PRODUCTS USING THE INTERNET. 
(a) IN GENERAL.—The Federal, Food, Drug, and 
Cosmetic Act is amended by inserting after section 715 
of such Act (21 U.S.C. 379d–4) the following: 
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‘‘SEC. 716. DISSEMINATION OF INFORMATION ABOUT MED-
ICAL PRODUCTS USING THE INTERNET. 
‘‘(a) PROPOSED
REVISIONS.—Not later than 6 
months after the date of enactment of this section, the 
Secretary shall— 
‘‘(1) review each regulation and guidance that 
applies to the dissemination by means of the Inter-
net (including social media platforms and character- 
limited applications) of information about medical 
products; and 
‘‘(2) propose revisions to such regulations and 
guidance (in the form of proposed amended regula-
tions and draft guidance, respectively) that— 
‘‘(A) facilitate meaningful use, by the 
sponsors of medical products, of the Internet, 
including 
Internet 
applications 
and 
social 
media, for dissemination of truthful, non-mis-
leading information about medical products; 
‘‘(B) recognize that such sponsors may use 
the Internet— 
‘‘(i) to disseminate, in character-lim-
ited applications, truthful, introductory in-
formation about medical products, includ-
ing the name of such products and their 
approved uses; and 
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‘‘(ii) to provide additional information 
about the safety and effectiveness of the 
medical products using information that is 
hyperlinked to such introductory informa-
tion; and 
‘‘(C) 
for 
regulatory 
purposes, 
treat 
hyperlinked information described in subpara-
graph (B)(ii) as if the information appeared in 
introductory information described in subpara-
graph (B)(i). 
‘‘(b) FINAL REGULATIONS
AND GUIDANCE; UP-
DATES.—The Secretary shall, after providing notice and 
an opportunity for public comment— 
‘‘(1) not later than 18 months after publication 
of proposed regulations and guidance pursuant to 
subsection (a), publish final regulations and guid-
ance addressing the matters described in subsection 
(a); and 
‘‘(2) periodically thereafter, review and, as ap-
propriate, update such regulations and guidance. 
‘‘(c) MEDICAL PRODUCT DEFINED.—In this section, 
the term ‘medical product’ means a drug, biological prod-
uct, or device.’’. 
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(b) CONFORMING REPEAL.—Section 1121 of the 
Food and Drug Administration Safety and Innovation Act 
(Public Law 112–144; 21 U.S.C. 379d–5) is repealed. 
Æ 
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