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 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. 

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 consideration 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 prescription 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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Fair Balance Prescrip3 tion Drug Advertisement Act of 2003’’. 

4 SEC. 2. DISALLOWANCE OF DEDUCTION FOR DIRECT-TO5 CONSUMER ADVERTISEMENT OF PRESCRIP6 TION DRUG THAT FAILS TO PROVIDE CER7 TAIN INFORMATION OR TO PRESENT BAL8 ANCED INFORMATION. 

9 (a) GENERAL RULE.—Part IX of subchapter B of 

10 chapter 1 of the Internal Revenue Code of 1986 (relating 

11 to items not deductible) is amended by adding at the end 

12 thereof the following new section: 

13 ‘‘SEC. 280I. DIRECT-TO-CONSUMER ADVERTISEMENT OF 

14 PRESCRIPTION DRUG THAT FAILS TO PRO15 VIDE CERTAIN INFORMATION OR TO 

16 PRESENT BALANCED INFORMATION. 

17 ‘‘No deduction shall be allowed under this chapter for 

18 any expense of an advertisement for a prescription drug 

19 if, with respect to such advertisement, the Secretary of 

20 Health and Human Services has submitted to the Sec21 retary of the Treasury a report under section 311 of the 

22 Federal Food, Drug, and Cosmetic Act.’’

23 (b) CLERICAL AMENDMENT.—The table of sections 

24 for part IX of subchapter B of chapter 1 of such Code 

25 is amended by adding at the end thereof the following new 

26 item:
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‘‘Sec. 280I. Direct-to-consumer advertisement of prescription drug 

that fails to provide certain information or to 

present balanced information.’’

1 (c) EFFECTIVE DATE.—The amendments made by 

2 this section shall apply to amounts paid or incurred after 

3 December 31, 2003. 

4 SEC. 3. PROHIBITIONS REGARDING DIRECT-TO-CONSUMER 

5 PRESCRIPTION DRUG ADVERTISING; RE6 PORTING OF VIOLATIONS TO INTERNAL REV7 ENUE SERVICE. 

8 Chapter III of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 331 et seq.) is amended by adding at the 

10 end the following section: 

11 ‘‘PROHIBITIONS REGARDING DIRECT-TO-CONSUMER PRE12 SCRIPTION DRUG ADVERTISING; REPORTING OF VIO13 LATIONS TO INTERNAL REVENUE SERVICE

14 ‘‘SEC. 311. With respect to a direct-to-consumer ad15 vertisement of a prescription drug, the Secretary shall re16 port to the Secretary of the Treasury—

17 ‘‘(1) any violation of section 301 involving the 

18 misbranding of the prescription drug by reason of 

19 failure to comply with the requirements of section 

20 502(n) that relate to the provision in the advertise21 ment of true statements relating to side effects, con22 traindications, and effectiveness; or 

23 ‘‘(2) any determination by the Secretary, made 

24 upon a petition of an interested person or the Sec-
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1 retary’s own initiative, that under criteria estab2 lished by the Secretary by regulation, the portion of 

3 the advertisement devoted to describing side effects, 

4 contraindications, or any lack of effectiveness is less 

5 than the portion of the advertisement devoted to de6 scribing the benefits of the drug, taking into account 

7 the amount and type size of any printed informa8 tion, whether all printed material is printed together 

9 or on facing or consecutive pages, the duration of 

10 the advertisement (in the case of an advertisement 

11 through media such as television or radio), and such 

12 other factors as the Secretary determines to be ap13 propriate.’’.

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