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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.
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