[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2352 Introduced in House (IH)]







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 
  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

                             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 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Fair Balance Prescription Drug 
Advertisement Act of 2001''.

SEC. 2. DISALLOWANCE OF DEDUCTION FOR DIRECT-TO-CONSUMER ADVERTISEMENT 
              OF PRESCRIPTION DRUG THAT FAILS TO PROVIDE CERTAIN 
              INFORMATION OR TO PRESENT BALANCED 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 PROVIDE 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 Secretary 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; REPORTING OF VIOLATIONS TO INTERNAL REVENUE 
              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 prescription drug 
    advertising; reporting of violations to internal revenue service

    ``Sec. 311. With respect to a direct-to-consumer advertisement of a 
prescription drug, the Secretary shall report 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 advertisement of true statements relating 
        to side effects, contraindications, and effectiveness; or
            ``(2) any determination by the Secretary, made upon a 
        petition of an interested person or the Secretary's own 
        initiative, that under criteria established 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 describing the benefits of the drug, taking into 
        account the amount and type size of any printed information, 
        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 appropriate.''
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