I
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 Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Accuracy in Pharma-
ceutical Advertisements Act’’.
SEC. 2. CIVIL PENALTY FOR CERTAIN DIRECT-TO-CON-
SUMER 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 in-
volving 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-con-
sumer 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 viola-
tion not later than 180 days after the date of
the notice.
‘‘(2) The amount of a civil penalty for a violation de-
scribed 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 viola-
tions 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 man-
ner 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 ‘‘Sec-
retary’’), acting through the Commissioner of Food and
Drugs, shall annually submit to the Committee on Energy
and Commerce of the House of Representatives, the Com-
mittee on Health, Education, Labor, and Pensions of the
Senate, and any other appropriate committee of the Con-
gress a report that, for the most recent 1-year period for
which data are available—
(1) provides the total number of such advertise-
ments 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 adver-
tisements 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 ap-
propriated to the Secretary such sums as may be nec-
essary, in addition to other authorizations of appropria-
tions that are available for such purpose.
Æ