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.

Bill: 114-hr-2479
Sponsor: full_name: Rep. Long, Billy [R-MO-7]
Introduced: 2015-05-20
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Food and Drug Administration (FDA)

Government information and archives

Internet and video services

Internet, web applications, social media
Latest action: action_date: 2015-05-22
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-05-20
action_desc: Introduced in House
text: <p>This bill amends the Federal Food, Drug, and Cosmetic Act to direct the Department of Health and Human Services (HHS) to review each regulation and guidance that applies to the dissemination by means of the Internet of information about medical products and to propose revisions to such regulations and guidance that:</p> <ul> <li> facilitate meaningful use of the Internet by product sponsors for dissemination of truthful, non-misleading information about medical products;</li> <li>recognize that such sponsors may use the Internet to disseminate, in character-limited applications, truthful, introductory information about medical products and to provide additional information about the safety and effectiveness of the medical products using information that is hyperlinked to such introductory information; and </li> <li>treat such hyperlinked information as if it appeared in such introductory information, for regulatory purposes.</li> </ul> <p>HHS is required, after providing notice and an opportunity for public comment, to: (1) publish final regulations and guidance addressing such matters within 18 months after publication of proposed regulations and guidance; and (2) review and update such regulations and guidance periodically.</p>

tv_txt: I 114th CONGRESS 1st Session H. R. 2479 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. 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: 716. Dissemination of information about medical 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 Internet (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 regulations 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-misleading information about medical products; (B) recognize that such sponsors may use the Internet— (i) to disseminate, in character-limited applications, truthful, introductory information about medical products, including the name of such products and their approved uses; and (ii) to provide additional information about the safety and effectiveness of the medical products using information that is hyperlinked to such introductory information; and (C) for regulatory purposes, treat hyperlinked information described in subparagraph (B)(ii) as if the information appeared in introductory information described in subparagraph (B)(i). (b) Final regulations and guidance; updates 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 guidance addressing the matters described in subsection (a); and (2) periodically thereafter, review and, as appropriate, update such regulations and guidance. (c) Medical product defined In this section, the term medical product means a drug, biological product, or device. . (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.