[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2520 Introduced in Senate (IS)]







106th CONGRESS
  2d Session
                                S. 2520

  To amend the Federal Food, Drug, and Cosmetic Act to allow for the 
    importation of certain covered products, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 9, 2000

 Mr. Jeffords (for himself, Mr. Wellstone, Ms. Snowe, and Ms. Collins) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to allow for the 
    importation of certain covered products, and for other purposes.

    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 ``Medicine Equity and Drug Safety Act 
of 2000''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) The cost of prescription drugs for Americans continues 
        to rise at an alarming rate.
            (2) Millions of Americans, including medicare beneficiaries 
        on fixed incomes, face a daily choice between purchasing life-
        sustaining prescription drugs, or paying for other necessities, 
        such as food and housing.
            (3) Many life-saving prescription drugs are available in 
        countries other than the United States at substantially lower 
        prices, even though such drugs were developed and are approved 
        for use by patients in the United States.
            (4) Many Americans travel to Canada or other countries to 
        purchase prescription drugs because the medicines that they 
        need are unaffordable in the United States.
            (5) Americans should be able to purchase medicines at 
        prices that are comparable to prices for such medicines in 
        other countries, but efforts to enable such purchases should 
        not endanger the gold standard for safety and effectiveness 
        that has been established and maintained in the United States.

SEC. 3. IMPORTATION OF COVERED PRODUCTS.

    Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381 et seq.) is amended--
            (1) in section 801(d)(1), by inserting ``and section 804'' 
        after ``paragraph (2)''; and
            (2) by adding at the end the following:

``SEC. 804. IMPORTATION OF COVERED PRODUCTS.

    ``(a) Regulations.--
            ``(1) In general.--Notwithstanding sections 301(d), 301(t), 
        and 801(a), the Secretary, after consultation with the United 
        States Trade Representative and the Commissioner of Customs, 
        shall promulgate regulations permitting importation into the 
        United States of covered products.
            ``(2) Limitation.--Regulations promulgated under paragraph 
        (1) shall--
                    ``(A) require that safeguards are in place that 
                provide a reasonable assurance to the Secretary that 
                each covered product that is imported is safe and 
                effective for its intended use;
                    ``(B) require that the individual, or pharmacist or 
                wholesaler, importing a covered product complies with 
                the provisions of subsection (b) or (c), as 
                appropriate; and
                    ``(C) contain such additional safeguards as the 
                Secretary may specify in order to ensure the safety of 
                patients in the United States.
            ``(3) Safeguards.--In determining safeguards for a covered 
        product under paragraph (2)(C), the Secretary shall consider 
        the adequacy of the regulatory structure of the exporting 
        country to ensure the safety and effectiveness of the covered 
        product.
            ``(4) Records.--Regulations promulgated under paragraph (1) 
        shall require that records regarding importation described in 
        subsections (b) and (c) be gathered and maintained by the 
        Secretary for a period of time determined to be necessary by 
        the Secretary.
    ``(b) Personal Baggage.--
            ``(1) In general.--The Secretary shall promulgate 
        regulations that permit an individual to import into the United 
        States a covered product in personal baggage.
            ``(2) Regulations.--Regulations promulgated under paragraph 
        (1) shall require an individual importing a covered product 
        to--
                    ``(A) affirm in writing that the product is for 
                personal use of the individual;
                    ``(B) seek to import an amount of the product 
                appropriate for personal use, such as a 3-month supply; 
                and
                    ``(C) provide to the Secretary--
                            ``(i) the name and address of a health 
                        professional licensed to prescribe drugs in the 
                        United States that is responsible for treatment 
with the product, or evidence that the product is for the continuation 
of a treatment begun in a foreign country;
                            ``(ii) a description of the product, 
                        including the name, the amount being imported, 
                        and the price paid for the product;
                            ``(iii) information indicating the 
                        destination of the product;
                            ``(iv) information indicating the date on 
                        which and the place where the product was 
                        purchased;
                            ``(v) the name, address, and telephone 
                        number of the importer; and
                            ``(vi) any other information that the 
                        Secretary determines is necessary to ensure 
                        that the product being imported is safe and 
                        effective for its intended use, and to ensure 
                        that the Secretary maintains the ability to 
                        track an imported product that is found to be 
                        counterfeit, expired, subpotent, or otherwise 
                        unsafe or ineffective for its intended use.
    ``(c) Reimportation.--
            ``(1) In general.--The Secretary shall promulgate 
        regulations that permit a pharmacist or wholesaler to import 
        into the United States a covered product that meets the 
        requirements of sections 501, 502, and 505, and was 
        manufactured in a State and exported, or in an establishment 
        registered under 510.
            ``(2) Regulations.--Regulations promulgated under paragraph 
        (1) shall require a pharmacist or wholesaler to provide to the 
        Secretary--
                    ``(A) a description of the product, including the 
                name, the amount being imported, and the price paid for 
                the product;
                    ``(B) information indicating the destination of the 
                product;
                    ``(C) information indicating the date on which and 
                the place where the product was purchased;
                    ``(D) the name, address, and telephone number of 
                the importer, and the professional license number of 
                the pharmacist or wholesaler;
                    ``(E) information demonstrating to the satisfaction 
                of the Secretary that the product being imported was 
                manufactured in a State or at an establishment 
                registered under section 510; and
                    ``(F) any other information that the Secretary 
                determines is necessary to ensure that the product 
                being imported is safe and effective.
    ``(d) Study and Report.--
            ``(1) Study.--The Secretary shall conduct, or contract with 
        an entity to conduct, a study on the imports permitted under 
        this section, taking into consideration the information 
        received under subsections (a), (b), and (c). In conducting 
        such study, the Secretary or entity shall evaluate the safety 
        and purity of the products imported, and other patent and trade 
        issues that may have an effect on the safety or availability of 
        such products .
            ``(2) Report.--Not later than 5 years after the date of 
        enactment of this section, the Secretary shall prepare and 
        submit to Congress a report containing the study described in 
        paragraph (1).
    ``(e) Construction.--Nothing in this section shall be construed to 
limit the statutory, regulatory, or enforcement authority of the 
Secretary relating to importation of covered products, other than the 
importation described in subsections (a), (b), and (c).
    ``(f) Limitation.--Information collected pursuant to this section 
shall be subject to the provisions of section 522a of title 5, United 
States Code (commonly known as the `Privacy Act of 1974').
    ``(g) Definitions.--In this section:
            ``(1) Covered product.--The term `covered product' means a 
        prescription drug under section 503(b)(1).
            ``(2) Pharmacist.--The term `pharmacist' means a person 
        licensed by a State to practice pharmacy in the United States, 
        including the dispensing and selling of prescription drugs.
            ``(3) Wholesaler.--The term `wholesaler' means a person 
        licensed as a wholesaler or distributor of prescription drugs 
        in the United States.''.
                                 <all>