[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4833 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 4833

    To amend the Federal Food, Drug, and Cosmetic Act to establish 
authority for the imposition of civil penalties for direct-to-consumer 
     advertisements that violate such Act, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 23, 2002

Mr. Allen (for himself, Mr. Berry, Mr. Langevin, Mr. Brown of Ohio, Mr. 
   Stark, Mr. Rangel, Ms. Kaptur, Mr. Baldacci, Ms. DeLauro, and Mr. 
   Waxman) 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 establish 
authority for the imposition of civil penalties for direct-to-consumer 
     advertisements that violate such Act, 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 ``Accuracy in Pharmaceutical 
Advertisements Act''.

SEC. 2. CIVIL PENALTY FOR CERTAIN DIRECT-TO-CONSUMER ADVERTISEMENTS OF 
              PRESCRIPTION DRUGS.

    Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333) is amended by adding at the end the following subsection:
    ``(h)(1) With respect to a violation of section 301 involving the 
misbranding of a prescription drug within the meaning of section 
502(n), any person that engages in such a violation shall be liable to 
the United States for a civil penalty if--
                    ``(A) the violation involves a direct-to-consumer 
                advertisement;
                    ``(B) the Secretary provides written notice of the 
                violation to the person; and
                    ``(C) the person fails to correct or cease the 
                advertisement so as to eliminate such violation not 
                later than 180 days after the date of the notice.
    ``(2) The amount of a civil penalty for a violation described in 
paragraph (1) shall not exceed $500,000 in the case of an individual 
and $5,000,000 in the case of any other person, not to exceed 
$10,000,000 for all such violations adjudicated in a single proceeding.
    ``(3) Paragraphs (3) through (5) of subsection (g) apply with 
respect to a civil penalty under paragraph (1) of this subsection to 
the same extent and in the same manner as such paragraphs (3) through 
(5) apply with respect to a civil penalty under paragraph (1) or (2) of 
subsection (g).''.

SEC. 3. REPORTS; PUBLIC NOTICE OF VIOLATIONS.

    With respect to direct-to-consumer advertisements for prescription 
drugs, the Secretary of Health and Human Services (referred to in this 
section as the ``Secretary''), acting through the Commissioner of Food 
and Drugs, shall annually submit to the Committee on Energy and 
Commerce of the House of Representatives, the Committee on Health, 
Education, Labor, and Pensions of the Senate, and any other appropriate 
committee of the Congress a report that, for the most recent 1-year 
period for which data are available--
            (1) provides the total number of such advertisements made 
        by television, radio, Internet, written publication, or other 
        media;
            (2) identifies, for each such advertisement--
                    (A) the dates on which, the times at which, and the 
                markets in which the advertisement was made; and
                    (B) the type of advertisement (reminder, help-
                seeking, or product-claim); and
            (3) identifies such advertisements that violated or 
        appeared to violate section 502(n) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 352(n)), and describes the actions 
        taken by the Secretary in response to the violations.

SEC. 4. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS FOR COMPLIANCE 
              FUNCTIONS.

    For the purpose of providing additional personnel and other 
resources to the Secretary of Health and Human Services for identifying 
direct-to-consumer advertisements for prescription drugs that violate 
section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
352(n)), and for taking actions under such Act in response to such 
violations, there are authorized to be appropriated to the Secretary 
such sums as may be necessary, in addition to other authorizations of 
appropriations that are available for such purpose.
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