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108th CONGRESS
  2d Session
                                S. 2445

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 19, 2004

  Mr. Edwards introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act relating to direct-
               to-consumer prescription 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 ``Direct to Consumer Prescription Drug 
Advertising Act of 2004''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) The pharmaceutical industry spent $2,700,000,000 on 
        direct to consumer advertising in 2001, nearly a 60 percent 
        increase since 1997.
            (2) Direct to consumer prescription drug advertisements can 
        significantly increase the number of sales. In 2000, almost 
        $2,500,000,000 was spent on direct to consumer advertising to 
        promote 50 different drugs. The following year, retail sales 
        for these drugs skyrocketed by 21.4 percent.
            (3) According to the Government Accounting Office, 
        pharmaceutical companies have increased spending on direct to 
        consumer advertising more rapidly than they have increased 
        spending on research and development.
            (4) New prescription drugs that are introduced into the 
        market are generally more expensive than older drugs in the 
        same class. Consequently, direct to consumer advertising may 
        lead consumers to spend more money on new prescription drugs 
        than those of similar quality.
            (5) Although direct to consumer prescription drug 
        advertisements aid consumer awareness, they are often 
        misleading as the benefits are more accessible than the risks.
            (6) There has been a sharp increase in sales for direct to 
        consumer advertised prescription drugs, which is 
        disproportionate to the growth in the market.
            (7) Due to a revision of procedure within the Department of 
        Health and Human Services, the Food and Drug Administration is 
        often too late to act on misleading direct to consumer 
        advertisements by the pharmaceutical industry. By the time they 
        revoke an advertisement, many consumers have already viewed the 
        misleading information.

SEC. 3. PRESCRIPTION DRUG COMPARATIVE EFFECTIVENESS.

    (a) In General.--With respect to each prescription drug that is 
covered under a plan offered under the Federal Employees Health 
Benefits Program under chapter 89 of title 5, United States Code, the 
Director of the National Institutes of Health shall conduct research 
that compares the effectiveness and safety of such prescription drug 
relative to other prescription drugs used to treat the same condition 
or disease.
    (b) Rule of Construction.--The results of the research conducted 
under subsection (a) shall not be construed to be a condition of 
approval under section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355).

SEC. 4. DIRECT-TO-CONSUMER ADVERTISING.

    (a) In General.--Not later than 180 days after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
promulgate amended regulations governing prescription drug 
advertisements.
    (b) Contents.--In addition to any other requirements, the 
regulations under subsection (a) shall require that--
            (1) any advertisement present a fair balance, comparable in 
        depth and detail, between--
                    (A) information relating to effectiveness of the 
                drug (including, if available, effectiveness in 
                comparison to other drugs for substantially the same 
                condition or conditions); and
                    (B) information relating to side effects and 
                contraindications;
            (2) any advertisement present a fair balance, comparable in 
        depth, between--
                    (A) aural and visual presentations relating to 
                effectiveness of the drug; and
                    (B) aural and visual presentations relating to side 
                effects and contraindications, except that nothing in 
                this section shall require explicit images or sounds 
                depicting side effects and contraindications;
            (3) prohibit false or misleading advertising that would 
        encourage a consumer to take the prescription drug for a use 
        other than a use for which the prescription drug is approved 
        under section 505 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355); and
            (4) require that any prescription drug that is the subject 
        of a direct-to-consumer advertisement include in the package in 
        which the prescription drug is sold to consumers a medication 
        guide explaining the benefits and risks of use of the 
        prescription drug in terms designed to be understandable to the 
        general public.

SEC. 5. 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) Direct-to-Consumer Prescription Drug Advertising.--
            ``(1) In general.--A person that commits a violation of 
        section 301 involving the misbranding of a prescription drug 
        (within the meaning of section 502(n)) in a direct-to-consumer 
        advertisement shall be assessed a civil penalty if--
                    ``(A) the Secretary provides the person written 
                notice of the violation; and
                    ``(B) the person fails to correct or cease the 
                advertisement so as to eliminate the violation not 
                later than 180 days after the date of the notice.
            ``(2) Amount.--The amount of a civil penalty under 
        paragraph (1)--
                    ``(A) shall not exceed $500,000 in the case of an 
                individual and $5,000,000 in the case of any other 
                person; and
                    ``(B) shall not exceed $10,000,000 for all such 
                violations adjudicated in a single proceeding.
            ``(3) Procedure.--Paragraphs (3) through (5) of subsection 
        (f) shall apply with respect to a civil penalty under paragraph 
        (1) of this subsection 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).''.

SEC. 6. REPORTS.

    The Secretary of Health and Human Services shall annually submit to 
the Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives a report that, for the most recent 1-year period for 
which data are available--
            (1) provides the total number of direct-to-consumer 
        prescription drug advertisements made by television, radio, the 
        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)(A) identifies the 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
            (B) describes the actions taken by the Secretary in 
        response to the violations.

SEC. 7. REVIEW OF DIRECT-TO-CONSUMER DRUG ADVERTISEMENTS.

    (a) In General.--The Secretary of Health and Human Services shall 
expedite, to the maximum extent practicable, reviews of the legality of 
direct-to-consumer drug advertisements.
    (b) Policy.--The Secretary of Health and Human Services shall not 
adopt or follow any policy that would have the purpose or effect of 
delaying reviews of the legality of direct-to-consumer drug 
advertisements except--
            (1) as a result of notice-and-comment rulemaking; or
            (2) as the Secretary determines to be necessary to protect 
        public health and safety.
                                 <all>

Pages: 1

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