I 
110TH CONGRESS 
1ST SESSION H. R. 2823 
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, 
to amend the Federal Food, Drug, and Cosmetic Act to require reports 
regarding such advertisements, and to amend such Code to deny any 
deduction for direct-to-consumer advertisements of qualified prescription 
drugs for a two-year period. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 21, 2007 
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, to 
amend the Federal Food, Drug, and Cosmetic Act to 
require reports regarding such advertisements, and to 
amend such Code to deny any deduction for direct-to- 
consumer advertisements of qualified prescription drugs 
for a two-year period. 
VerDate Aug 31 2005 
04:19 Jun 23, 2007
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6652
E:\BILLS\H2823.IH
H2823
hmoore on PRODPC68 with HMBILLS
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 2007’’. 
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 
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.’’. 
VerDate Aug 31 2005 
04:19 Jun 23, 2007
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H2823.IH
H2823
hmoore on PRODPC68 with HMBILLS
(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 the following new item: 
‘‘Sec. 280I. Direct-to-consumer advertisement of prescription drug that fails to 
provide certain information or to present balanced informa-
tion.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to amounts paid or incurred after 
December 31, 2007. 
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-
VerDate Aug 31 2005 
04:19 Jun 23, 2007
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H2823.IH
H2823
hmoore on PRODPC68 with HMBILLS
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.’’. 
SEC. 4. DISALLOWANCE OF DEDUCTION FOR DIRECT-TO- 
CONSUMER ADVERTISEMENT OF QUALIFIED 
PRESCRIPTION DRUG FOR TWO-YEAR PE-
RIOD. 
(a) GENERAL RULE.—Part IX of subchapter B of 
chapter 1 of the Internal Revenue Code of 1986 (as 
amended by section 2) is amended by adding at the end 
the following new section: 
VerDate Aug 31 2005 
04:19 Jun 23, 2007
Jkt 059200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2823.IH
H2823
hmoore on PRODPC68 with HMBILLS
‘‘SEC. 280J. DIRECT-TO-CONSUMER ADVERTISEMENT OF 
QUALIFIED PRESCRIPTION DRUG. 
‘‘(a) IN GENERAL.—No deduction shall be allowed 
under this chapter for any expense of an advertisement 
for a qualified prescription drug paid or incurred during 
the two-year period beginning on the date that the quali-
fied prescription drug is first introduced into interstate 
commerce. 
‘‘(b) QUALIFIED PRESCRIPTION DRUG.—For pur-
poses of this section, the term ‘qualified prescription drug’ 
means a new drug, a new combination of active sub-
stances, or a new delivery system for an existing drug. 
‘‘(c) DISCRETIONARY AUTHORITY.—At the discretion 
of the Secretary, and in consultation with the Commis-
sioner of Food and Drugs, the Secretary may exempt a 
qualified prescription drug from the disallowance of a de-
duction under subsection (a).’’. 
(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 the following new item: 
‘‘Sec. 280J. Direct-to-consumer advertisement of qualified prescription drug.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to amounts paid or incurred after 
December 31, 2007. 
Æ 
VerDate Aug 31 2005 
04:19 Jun 23, 2007
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6301
E:\BILLS\H2823.IH
H2823
hmoore on PRODPC68 with HMBILLS