I 
108TH CONGRESS 
1ST SESSION H. R. 3155
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 
SEPTEMBER 23, 2003
Mr. STARK (for himself, Mr. EMANUEL, and Mr. GRIJALVA) 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 consider-
ation of such provisions as fall within the jurisdiction 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 2003’’. 
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, 2003. 
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-