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 dissemination 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. 

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

3 SECTION 1. DISSEMINATION OF INFORMATION ABOUT 

4 MEDICAL PRODUCTS USING THE INTERNET. 

5 (a) IN GENERAL.—The Federal, Food, Drug, and 

6 Cosmetic Act is amended by inserting after section 715 

7 of such Act (21 U.S.C. 379d–4) the following: 


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1 ‘‘SEC. 716. DISSEMINATION OF INFORMATION ABOUT MED2 ICAL PRODUCTS USING THE INTERNET. 

3 ‘‘(a) PROPOSED REVISIONS.—Not later than 6 

4 months after the date of enactment of this section, the 

5 Secretary shall— 

6 ‘‘(1) review each regulation and guidance that 

7 applies to the dissemination by means of the Inter8 net (including social media platforms and character9 limited applications) of information about medical 

10 products; and 

11 ‘‘(2) propose revisions to such regulations and 

12 guidance (in the form of proposed amended regula13 tions and draft guidance, respectively) that— 

14 ‘‘(A) facilitate meaningful use, by the 

15 sponsors of medical products, of the Internet, 

16 including Internet applications and social 

17 media, for dissemination of truthful, non-mis18 leading information about medical products; 

19 ‘‘(B) recognize that such sponsors may use 

20 the Internet— 

21 ‘‘(i) to disseminate, in character-lim22 ited applications, truthful, introductory in23 formation about medical products, includ24 ing the name of such products and their 

25 approved uses; and 


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1 ‘‘(ii) to provide additional information 

2 about the safety and effectiveness of the 

3 medical products using information that is 

4 hyperlinked to such introductory informa5 tion; and 

6 ‘‘(C) for regulatory purposes, treat 

7 hyperlinked information described in subpara8 graph (B)(ii) as if the information appeared in 

9 introductory information described in subpara10 graph (B)(i). 

11 ‘‘(b) FINAL REGULATIONS AND GUIDANCE; UP12 DATES.—The Secretary shall, after providing notice and 

13 an opportunity for public comment— 

14 ‘‘(1) not later than 18 months after publication 

15 of proposed regulations and guidance pursuant to 

16 subsection (a), publish final regulations and guid17 ance addressing the matters described in subsection 

18 (a); and 

19 ‘‘(2) periodically thereafter, review and, as ap20 propriate, update such regulations and guidance. 

21 ‘‘(c) MEDICAL PRODUCT DEFINED.—In this section, 

22 the term ‘medical product’ means a drug, biological prod23 uct, or device.’’. 


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1 (b) CONFORMING REPEAL.—Section 1121 of the 

2 Food and Drug Administration Safety and Innovation Act 

3 (Public Law 112–144; 21 U.S.C. 379d–5) is repealed. 

Æ 


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