[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3950 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 3950

To amend the Federal Food, Drug, and Cosmetic Act with respect to drug 
                  advertising, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 29, 2005

  Ms. DeLauro (for herself and Mrs. Emerson) 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 with respect to drug 
                  advertising, and for other purposes.

    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 2005''.

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, by adding at the end the following:
    ``(hh) The conduct of direct-to-consumer advertising of a drug in 
violation of section 506D.''; and
            (2) in chapter V, by inserting after section 506C the 
        following:

``SEC. 506D. 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.''.

SEC. 3. PROMINENT DISPLAY OF INFORMATION IN ADVERTISING ON SIDE 
              EFFECTS, CONTRAINDICATIONS, AND EFFECTIVENESS.

    (a) Requirement.--Paragraph (3) of section 502(n) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended--
            (1) by redesignating subparagraphs (A) and (B) as clauses 
        (i) and (ii); and
            (2) by striking ``such other information'' and all that 
        follows through ``which shall be issued by'' and inserting 
        ``such other information in brief summary relating to side 
        effects, contraindications, and effectiveness as shall be 
        required in regulations which (A) shall require such 
        information to be prominently displayed in terms of font size 
        and location and (B) shall be issued by''.
    (b) Effective Date.--The amendment made by this section applies 
with respect to any advertisement or other descriptive printed matter 
that is issued or caused to be issued on or after the date that is 90 
days after the enactment of this Act. Not later than such date, the 
Secretary shall revise any regulations promulgated pursuant to 
subsection (n) of section 503 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) to the extent necessary to implement this section.

SEC. 4. CIVIL PENALTY.

    Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333) is amended by adding at the end the following:
    ``(g) Drug Advertising and Promotion.--
            ``(1) Civil penalty.--
                    ``(A) In general.--Any manufacturer, packer, or 
                distributor of a drug who violates section 505(n), 
                section 506D, or any other requirement of this Act 
                relating to the advertising or promotion of the drug 
                shall be subject to a civil penalty in an amount not to 
                exceed--
                            ``(i) in the case of the first such 
                        violation by the manufacturer, packer, or 
                        distributor relating to the drug, $250,000; and
                            ``(ii) in the case of each subsequent 
                        violation by the manufacturer, packer, or 
                        distributor relating to the drug, an amount 
                        that is twice the amount of the maximum civil 
                        penalty applicable under this subparagraph to 
                        the previous violation.
                    ``(B) Procedure.--Paragraphs (3) through (5) of 
                subsection (f) shall apply with respect to a civil 
                penalty under subparagraph (A) to the same extent and 
                in the same manner as those paragraphs apply with 
                respect to a civil penalty under paragraph (1) or (2) 
                of subsection (f).
            ``(2) Distribution of materials.--If the Secretary finds 
        that a person committed a violation described in paragraph 
        (1)(A), the Secretary may order the person to distribute 
        materials in the same markets in which the violative 
        advertisement or promotional material was distributed in a 
        manner designed to notify the public and the medical community 
        of the violation and to provide corrective information.
            ``(3) Separate offense.--For purposes of imposing a civil 
        penalty under this subsection, each violation described in 
        paragraph (1)(A), including each distribution of a direct-to-
        consumer advertisement in violation of section 506A, shall 
        constitute a separate offense.
            ``(4) Relation to other penalties.--A civil penalty under 
        paragraph (1) and an order under paragraph (2) shall be in 
        addition to any other penalty applicable under this Act or 
        other law to the violation involved.''.

SEC. 5. ORDER REQUIRING POSTMARKET CHANGE IN LABELING.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is 
amended--
            (1) in section 502, by adding at the end the following:
    ``(x) If it is a drug and its labeling fails to comply with an 
order issued pursuant to section 506E, or the manufacturer of the drug 
fails to provide notification to physicians as required by the 
Secretary pursuant to such section.''; and
            (2) by inserting after section 506D, as added by section 2, 
        the following:

``SEC. 506E. POSTMARKET CHANGE IN LABELING.

    ``(a) In General.--In the case of any drug for which an approval of 
an application submitted under section 505(b) or (j) is in effect, the 
Secretary may require by order that information, including specific 
wording, be included in the labeling of a drug on the basis that such 
information is necessary to ensure the safe and effective use of the 
drug.
    ``(b) Notification.--If the Secretary issues an order described in 
subsection (a), the Secretary may require the manufacturer of the drug 
involved to notify the public and the medical community of the labeling 
change.''.

SEC. 6. PUBLIC EDUCATION CAMPAIGN ON RISKS OF CERTAIN DRUGS.

    The Secretary of Health and Human Services shall conduct an 
education campaign to increase public awareness of risks that, for some 
patients, may outweigh the benefits of using a particular drug, whether 
such risks are known at the time of the approval of the drug or become 
known after the approval of the drug.

SEC. 7. ADDITIONAL FUNDING FOR REGULATION OF DIRECT-TO-CONSUMER DRUG 
              ADVERTISING.

    There are authorized to be appropriated to the Food and Drug 
Administration $2,500,000 for each of fiscal years 2007 and 2008 for 
the purpose of regulating direct-to-consumer drug advertisements, 
including by carrying out the amendments made by section 2. The 
authorization of appropriations in the preceding sentence is in 
addition to any other authorization of appropriations for such purpose.
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