[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 578 Introduced in House (IH)]






109th CONGRESS
  1st Session
                                H. R. 578

To amend the Internal Revenue Code of 1986 with respect to the purchase 
of prescription drugs by individuals who have attained retirement age, 
 and to amend the Federal Food, Drug, and Cosmetic Act with respect to 
   the importation of prescription drugs and the sale of such drugs 
                        through Internet sites.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 2, 2005

   Mr. Paul introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
   Ways and Means, 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 with respect to the purchase 
of prescription drugs by individuals who have attained retirement age, 
 and to amend the Federal Food, Drug, and Cosmetic Act with respect to 
   the importation of prescription drugs and the sale of such drugs 
                        through Internet sites.

    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 ``Prescription Drug Affordability 
Act''.

          TITLE I--AMENDMENTS TO INTERNAL REVENUE CODE OF 1986

SEC. 101. INCOME TAX CREDIT FOR PRESCRIPTION DRUGS PURCHASED BY 
              INDIVIDUALS WHO HAVE ATTAINED RETIREMENT AGE.

    (a) In General.--Subpart A of part IV of subchapter A of chapter 1 
of the Internal Revenue Code of 1986 (relating to nonrefundable 
personal credits) is amended by inserting after section 25B the 
following new section:

``SEC. 25C. PRESCRIPTION DRUGS PURCHASED BY INDIVIDUALS WHO HAVE 
              ATTAINED SOCIAL SECURITY RETIREMENT AGE.

    ``(a) In General.--In the case of an individual who has attained 
social security retirement age, there shall be allowed as a credit 
against the tax imposed by this chapter for the taxable year an amount 
equal to 80 percent of the amount paid by the taxpayer during the 
taxable year (and not compensated for by insurance or otherwise) for 
any prescribed drug (as defined in section 213(d)(3)) for use by such 
individual.
    ``(b) Social Security Retirement Age.--For purposes of this 
section, the term `social security retirement age' means retirement age 
(as defined in section 216(l)(1) of the Social Security Act).
    ``(c) Denial of Double Benefit.--
            ``(1) Coordination with medical expense deduction.--The 
        amount which would (but for this subsection) be taken into 
        account by the taxpayer under section 213 for the taxable year 
        shall be reduced by the credit (if any) allowed by this section 
        to the taxpayer for such year.
            ``(2) Coordination with medical and health savings 
        accounts.--No credit shall be allowed under this section for 
        amounts paid from any Archer MSA (as defined in section 220(d)) 
        or any health savings account (as defined in section 223(d)).
    ``(d) Election not to Have Credit Apply.--This section shall not 
apply to a taxpayer for a taxable year if the taxpayer elects not to 
have this section apply for such year.''.
    (b) Clerical Amendment.--The table of sections for subpart A of 
part IV of subchapter A of chapter 1 of such Code is amended by 
inserting after the item relating to section 25B the following new 
item:

``Sec. 25C. Prescription drugs purchased by individuals who have 
                            attained social security retirement age.''
    (c) Effective Date.--The amendments made by this section shall 
apply to taxable years beginning more than 1 year after the date of the 
enactment of this Act.

      TITLE II--AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT

SEC. 201. FACILITATION OF IMPORTATION OF DRUGS APPROVED BY FOOD AND 
              DRUG ADMINISTRATION.

    (a) In General.--Chapter VIII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381 et seq.) is amended--
            (1) by striking section 804; and
            (2) in section 801(d)--
                    (A) by striking paragraph (2); and
                    (B) by striking ``(d)(1)'' and all that follows 
                through the end of paragraph (1) and inserting the 
                following:
    ``(d)(1)(A) A person who meets applicable legal requirements to be 
an importer of drugs described in subparagraph (B) may import such a 
drug (without regard to whether the person is a manufacturer of the 
drug) if the person submits to the Secretary an application to import 
the drug and the Secretary approves the application.
    ``(B) For purposes of subparagraph (A), the drugs described in this 
subparagraph are drugs that are subject to section 503(b)(1) or that 
are composed wholly or partly of insulin.
    ``(C) The Secretary shall approve an application under subparagraph 
(A) if the application demonstrates that the drug to be imported meets 
all requirements under this Act for the admission of the drug into the 
United States, including demonstrating that--
            ``(i) an application for the drug has been approved under 
        section 505, or as applicable, under section 351 of the Public 
        Health Service Act; and
            ``(ii) the drug is not adulterated or misbranded.
    ``(D) Not later than 60 days after the date on which an application 
under subparagraph (A) is submitted to the Secretary, the Secretary 
shall--
            ``(i) approve the application; or
            ``(ii) refuse to approve the application and provide to the 
        person who submitted the application the reason for such 
        refusal.
    ``(E) This paragraph may not be construed as affecting any right 
secured by patent.''.
    (b) Conforming Amendments.--Section 801(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended--
            (1) by redesignating paragraphs (3) and (4) as paragraphs 
        (2) and (3), respectively;
            (2) in subclause (III) of paragraph (2)(A)(i) (as 
        redesignated by this subsection), by striking ``paragraph (4)'' 
        and inserting ``paragraph (3)''; and
            (3) in paragraph (3) (as redesignated by this subsection), 
        by striking ``paragraph (3)'' each place such term appears and 
        inserting ``paragraph (2)''.

SEC. 202. INTERNET SALES OF PRESCRIPTION DRUGS.

    Section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(b)) is amended by adding at the end the following paragraph:
    ``(6)(A) With respect to the interstate sale of a prescription drug 
through an Internet site, the Secretary may not with respect to such 
sale take any action under this Act against any of the persons involved 
if--
            ``(i) the sale was made in compliance with this Act and 
        with State laws that are applicable to the sale of the drug; 
        and
            ``(ii) accurate information regarding compliance with this 
        Act and such State laws is posted on the Internet site.
    ``(B) For purposes of subparagraph (A), the sale of a prescription 
drug by a person shall be considered to be an interstate sale of the 
drug through an Internet site if--
            ``(i) the purchaser of the drug submits the purchase order 
        for the drug, or conducts any other part of the sales 
        transaction for the drug, through an Internet site; and
            ``(ii) pursuant to such sale, the person introduces the 
        drug into interstate commerce or delivers the drug for 
        introduction into such commerce.
    ``(C) Subparagraph (A) may not be construed as authorizing the 
Secretary to enforce any violation of State law.
    ``(D) For purposes of this paragraph, the term `prescription drug' 
means a drug that is subject to paragraph (1).''.

SEC. 203. REGULATIONS OF SECRETARY OF HEALTH AND HUMAN SERVICES; 
              EFFECTIVE DATE.

    (a) Regulations.--Before the expiration of the period specified in 
subsection (b), the Secretary of Health and Human Services shall 
promulgate regulations to carry out the amendments to the Federal Food, 
Drug, and Cosmetic Act that are made by sections 201 and 202.
    (b) Effective Date.--The amendments to the Federal Food, Drug, and 
Cosmetic Act that are made by sections 201 and 202 take effect upon the 
expiration of the one-year period beginning on the date of the 
enactment of this Act, without regard to whether the regulations 
required in subsection (a) have been promulgated.
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