I
107TH CONGRESS
1ST SESSION
H. R. 2352
To amend the Internal Revenue Code of 1986 to deny any deduction for
direct-to-consumer advertisements of prescription drugs that fail to pro-
vide certain information or to present information in a balanced manner,
and to amend the Federal Food, Drug, and Cosmetic Act to require
reports regarding such advertisements.
IN THE HOUSE OF REPRESENTATIVES
JUNE 27, 2001
Mr. STARK introduced the following bill; which was referred to the Committee
on Ways and Means, and in addition to the Committee on Energy and
Commerce, for a period to be subsequently determined by the Speaker,
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned
A BILL
To amend the Internal Revenue Code of 1986 to deny any
deduction for direct-to-consumer advertisements of pre-
scription drugs that fail to provide certain information
or to present information in a balanced manner, and
to amend the Federal Food, Drug, and Cosmetic Act
to require reports regarding such advertisements.
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 ‘‘Fair Balance Prescrip-
tion Drug Advertisement Act of 2001’’.
SEC. 2. DISALLOWANCE OF DEDUCTION FOR DIRECT-TO-
CONSUMER ADVERTISEMENT OF PRESCRIP-
TION DRUG THAT FAILS TO PROVIDE CER-
TAIN INFORMATION OR TO PRESENT BAL-
ANCED INFORMATION.
(a) GENERAL RULE.—Part IX of subchapter B of
chapter 1 of the Internal Revenue Code of 1986 (relating
to items not deductible) is amended by adding at the end
thereof the following new section:
‘‘SEC. 280I. DIRECT-TO-CONSUMER ADVERTISEMENT OF
PRESCRIPTION DRUG THAT FAILS TO PRO-
VIDE 
CERTAIN 
INFORMATION 
OR 
TO
PRESENT BALANCED INFORMATION.
‘‘No deduction shall be allowed under this chapter for
any expense of an advertisement for a prescription drug
if, with respect to such advertisement, the Secretary of
Health and Human Services has submitted to the Sec-
retary of the Treasury a report under section 311 of the
Federal Food, Drug, and Cosmetic Act.’’
(b) CLERICAL AMENDMENT.—The table of sections
for part IX of subchapter B of chapter 1 of such Code
is amended by adding at the end thereof the following new
item:
‘‘Sec. 280I. Direct-to-consumer advertisement of prescription drug
that fails to provide certain information or to
present balanced information.’’
(c) EFFECTIVE DATE.—The amendments made by
this section shall apply to amounts paid or incurred after
December 31, 2001.
SEC. 3. PROHIBITIONS REGARDING DIRECT-TO-CONSUMER
PRESCRIPTION 
DRUG 
ADVERTISING; 
RE-
PORTING OF VIOLATIONS TO INTERNAL REV-
ENUE SERVICE.
Chapter III of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 331 et seq.) is amended by adding at the
end the following section:
‘‘PROHIBITIONS REGARDING DIRECT-TO-CONSUMER PRE-
SCRIPTION DRUG ADVERTISING; REPORTING OF VIO-
LATIONS TO INTERNAL REVENUE SERVICE
‘‘SEC. 311. With respect to a direct-to-consumer ad-
vertisement of a prescription drug, the Secretary shall re-
port to the Secretary of the Treasury—
‘‘(1) any violation of section 301 involving the
misbranding of the prescription drug by reason of
failure to comply with the requirements of section
502(n) that relate to the provision in the advertise-
ment of true statements relating to side effects, con-
traindications, and effectiveness; or
‘‘(2) any determination by the Secretary, made
upon a petition of an interested person or the Sec-
retary’s own initiative, that under criteria estab-
lished by the Secretary by regulation, the portion of
the advertisement devoted to describing side effects,
contraindications, or any lack of effectiveness is less
than the portion of the advertisement devoted to de-
scribing the benefits of the drug, taking into account
the amount and type size of any printed informa-
tion, whether all printed material is printed together
or on facing or consecutive pages, the duration of
the advertisement (in the case of an advertisement
through media such as television or radio), and such
other factors as the Secretary determines to be ap-
propriate.’’
Æ