Pharmaceutical Freedom Act of 2000

Summary: Title II: Amendments to Federal Food, Drug, and Cosmetic Act
 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to replace drug reimportation provisions with provisions which permit a person who meets applicable legal requirements to be an importer of drugs to import certain drugs (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.
Prohibits the Secretary from taking any action under the FDCA with respect to the interstate sale of a prescription drug through an Internet site, if the sale was made in compliance with the FDCA and with applicable State laws and accurate information regarding compliance with the FDCA and such State laws is posted on the Internet site.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pharmaceutical Freedom Act of 
2000''.

          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 25A the 
following new section:

``SEC. 25B. 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 savings accounts.--No 
        credit shall be allowed under this section for amounts paid 
        from any medical savings account (as defined in section 
        220(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 25A the following new 
item:

                              ``Sec. 25B. 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.--Section 801(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(d)) is amended--
            (1) by striking paragraph (2); and
            (2) 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; and
            (2) in paragraph (3) (as so redesignated) 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.