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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2479 Introduced in House (IH)]

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.

    Be it enacted by the Senate and House of Representatives 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:

``SEC. 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        (in the form of proposed amended regulations and draft 
        guidance, respectively) that--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.
                                 <all>
```