[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4565 Introduced in House (IH)]

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114th CONGRESS
  2d Session
                                H. R. 4565

 To amend the Federal Food, Drug, and Cosmetic Act to restrict direct-
                     to-consumer drug advertising.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 12, 2016

 Ms. DeLauro 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 restrict direct-
                     to-consumer drug advertising.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Responsibility in Drug Advertising 
Act of 2016''.

SEC. 2. DIRECT-TO-CONSUMER DRUG ADVERTISING.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is 
amended--
            (1) in section 301 (21 U.S.C. 331), by adding at the end 
        the following:
    ``(eee) The conduct of direct-to-consumer advertising of a drug in 
violation of section 506G.''; and
            (2) in chapter V, by inserting after section 506F (21 
        U.S.C. 356f) the following:

``SEC. 506G. DIRECT-TO-CONSUMER DRUG ADVERTISING.

    ``(a) Prohibitions.--
            ``(1) First three years.--
                    ``(A) In general.--Subject to subparagraph (B), no 
                person shall conduct direct-to-consumer advertising of 
                a drug for which an application is submitted under 
                section 505(b) before the end of the 3-year period 
                beginning on the date of the approval of such 
                application.
                    ``(B) Waiver.--The Secretary may waive the 
                application of subparagraph (A) to a drug during the 
                third year of the 3-year period described in such 
                subparagraph if--
                            ``(i) the sponsor of the drug submits an 
                        application to the Secretary pursuant to 
                        subparagraph (C); and
                            ``(ii) the Secretary, after considering the 
                        application and any accompanying materials, 
                        determines that direct-to-consumer advertising 
                        of the drug would have an affirmative value to 
                        public health.
                    ``(C) Application for waiver.--To seek a waiver 
                under subparagraph (B), the sponsor of a drug shall 
                submit an application to the Secretary at such time, in 
                such manner, and containing such information as the 
                Secretary may require.
            ``(2) Subsequent years.--The Secretary may prohibit direct-
        to-consumer advertising of a drug during the period beginning 
        at the end of the 3-year period described in paragraph (1)(A) 
        if the Secretary determines that the drug has significant 
        adverse health effects based on post-approval studies, risk-
        benefit analyses, adverse event reports, the scientific 
        literature, any clinical or observational studies, or any other 
        appropriate resource.
    ``(b) Regulations.--Not later than 1 year after the date of the 
enactment of this section, the Secretary shall revise the regulations 
promulgated under this Act governing drug advertisements to the extent 
necessary to implement this section.
    ``(c) Rule of Construction.--This section shall not be construed to 
diminish the authority of the Secretary to prohibit or regulate direct-
to-consumer advertising of drugs under other provisions of law.
    ``(d) Effective Date.--This section applies only with respect to a 
drug for which an application submitted under section 505(b) is 
approved on or after the date that is 1 year before the date of the 
enactment of this section.''.
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