[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 215 Introduced in Senate (IS)]







107th CONGRESS
  1st Session
                                 S. 215

To amend the Federal Food, Drug, and Cosmetic Act to permit importation 
    in personal baggage and by mail of certain covered products for 
personal use from certain foreign countries and to correct impediments 
 in implementation of the Medicine Equity and Drug Safety Act of 2000.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 30, 2001

 Ms. Stabenow 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 permit importation 
    in personal baggage and by mail of certain covered products for 
personal use from certain foreign countries and to correct impediments 
 in implementation of the Medicine Equity and Drug Safety Act of 2000.

    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 ``Medication Equity and Drug Savings 
Act''.

SEC. 2. IMPORTATION OF COVERED PRODUCTS FOR PERSONAL USE.

    (a) In General.--Chapter VIII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381 et seq.) is amended by adding at the end 
the following:

``SEC. 805. IMPORTATION OF COVERED PRODUCTS FOR PERSONAL USE.

    ``(a) Definitions.--In this section:
            ``(1) Covered product.--The term `covered product' means a 
        prescription drug described in section 503(b)(1).
            ``(2) Foreign country.--The term `foreign country' means--
                    ``(A) Australia, Canada, Israel, Japan, New 
                Zealand, Switzerland, and South Africa; and
                    ``(B) any other country, union, or economic area 
                that the Secretary designates for the purposes of this 
                section, subject to such limitations as the Secretary 
                determines to be appropriate to protect the public 
                health.
            ``(3) Market value.--The term `market value' means--
                    ``(A) the price paid for a covered product in 
                foreign country; or
                    ``(B) in the case of a gift, the price at which the 
                covered product is being sold in the foreign country 
                from which the covered product is imported.
    ``(b) Importation in Person.--
            ``(1) Regulations.--Notwithstanding subsections (d) and (t) 
        of section 301 and section 801(a), the Secretary shall 
        promulgate regulations permitting individuals to import into 
        the United States from a foreign country, in personal baggage, 
        a covered product that meets--
                    ``(A) the conditions specified in paragraph (2); 
                and
                    ``(B) such additional criteria as the Secretary 
                specifies to ensure the safety of patients in the 
                United States.
            ``(2) Conditions.--A covered product may be imported under 
        the regulations if--
                    ``(A) the intended use of the covered product is 
                appropriately identified;
                    ``(B) the covered product is not considered to 
                represent a significant health risk (as determined by 
                the Secretary without any consideration given to the 
                cost or availability of such a product in the United 
                States); and
                    ``(C) the individual seeking to import the covered 
                product--
                            ``(i) states in writing that the covered 
                        product is for the personal use of the 
                        individual;
                            ``(ii) seeks to import a quantity of the 
                        covered product appropriate for personal use, 
                        such as a 90-day supply;
                            ``(iii) provides the name and address of a 
                        health professional licensed to prescribe drugs 
                        in the United States that is responsible for 
                        treatment with the covered product or provides 
                        evidence that the covered product is for the 
                        continuation of a treatment begun in a foreign 
                        country;
                            ``(iv) provides a detailed description of 
                        the covered product being imported, including 
                        the name, quantity, and market value of the 
                        covered product;
                            ``(v) provides the time when and the place 
                        where the covered product is purchased;
                            ``(vi) provides the port of entry through 
                        which the covered product is imported;
                            ``(vii) provides the name, address, and 
                        telephone number of the individual who is 
                        importing the covered product; and
                            ``(viii) provides any other information 
                        that the Secretary determines to be necessary, 
                        including such information as the Secretary 
                        determines to be appropriate to identify the 
                        facility in which the covered product was 
                        manufactured.
            ``(3) Importation by an individual other than the 
        patient.--The regulations shall permit an individual who seeks 
        to import a covered product under this subsection to designate 
        another individual to effectuate the importation if the 
        individual submits to the Secretary a certification by a health 
        professional licensed to prescribe drugs in the United States 
        that travelling to a foreign country to effectuate the 
        importation would pose a significant risk to the health of the 
        individual.
            ``(4) Consultation.--In promulgating regulations under 
        paragraph (1), the Secretary shall consult with the United 
        States Trade Representative and the Commissioner of Customs.
    ``(c) Importation by Mail.--
            ``(1) Regulations.--Notwithstanding subsections (d) and (t) 
        of section 301 and section 801(a), the Secretary shall 
        promulgate regulations permitting individuals to import into 
        the United States by mail a covered product that meets such 
        criteria as the Secretary specifies to ensure the safety of 
        patients in the United States.
            ``(2) Criteria.--In promulgating regulations under 
        paragraph (1), the Secretary shall impose the conditions 
        specified in subsection (b)(2) to the maximum extent 
        practicable.
            ``(3) Consultation.--In promulgating regulations under 
        paragraph (1), the Secretary shall consult with the United 
        States Trade Representative and the Commissioner of Customs.
    ``(d) Records.--Any information documenting the importation of a 
covered product under subsections (b) and (c) shall be gathered and 
maintained by the Secretary for such period as the Secretary determines 
to be appropriate.
    ``(e) Study and Report.--
            ``(1) Study.--The Secretary shall conduct a study on the 
        imports permitted under this section, taking into consideration 
        the information received under subsections (b) and (c).
            ``(2) Evaluations.--In conducting the study, the Secretary 
        shall evaluate--
                    ``(A) the safety and purity of the covered products 
                imported; and
                    ``(B) patent, trade, and other issues that may have 
                an effect on the safety or availability of the covered 
                products.
            ``(3) Report.--Not later than 5 years after the date of 
        enactment of this section, the Secretary shall submit to 
        Congress a report describing the results of the study.
    ``(f) No Effect on Other Authority.--Nothing in this section limits 
the statutory, regulatory, or enforcement authority of the Secretary 
relating to importation of covered products, other than the importation 
described in subsections (b) and (c).
    ``(g) Limitation.--Information collected under this section shall 
be subject to section 522a of title 5, United States Code.''.
    (b) Conforming Amendment.--Section 801(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(d)(1)) is amended by striking 
``section 804'' and inserting ``sections 804 and 805''.

SEC. 3. CORRECTION OF IMPEDIMENTS IN IMPLEMENTATION OF MEDICINE EQUITY 
              AND DRUG SAFETY ACT OF 2000.

    (a) Access to Labeling to Permit Importation.--Section 804 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (2), by striking ``and'' at the 
                end;
                    (B) in paragraph (3), by striking the period at the 
                end and inserting ``; and''; and
                    (C) by adding at the end the following paragraph:
            ``(4) specify a fair and reasonable fee that a manufacturer 
        may charge an importer for printing and shipping labels for a 
        covered product for use by the importer.'';
            (2) in subsection (e)(2), by inserting after ``used only 
        for purposes of testing'' the following: ``or the labeling of 
        covered products''; and
            (3) in subsection (h)--
                    (A) by striking ``No manufacturer'' and inserting 
                the following:
            ``(1) In general.--No manufacturer''; and
                    (B) by adding at the end the following:
            ``(2) No conditions for labeling.--No manufacturer of a 
        covered product may impose any condition for the privilege of 
        an importer in using labeling for a covered product, except a 
        requirement that the importer pay a fee for such use 
        established by regulation under subsection (b)(4).''.
    (b) Prohibition of Pricing Conditions.--Paragraph (1) of section 
804(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(h)) 
(as designated by subsection (a)(3)(A)) is amended by inserting before 
the period at the end the following: ``that--
                    ``(A) imposes a condition regarding the price at 
                which an importer may resell a covered product; or
                    ``(B) discriminates against a person on the basis 
                of--
                            ``(i) importation by the person of a 
                        covered product imported under subsection (a); 
                        or
                            ``(ii) sale or distribution by the person 
                        of such covered products''.
    (c) Conditions for Taking Effect.--Section 804 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384) is amended by striking 
subsection (l) and inserting the following:
     ``(l) Conditions for Taking Effect.--
            ``(1) In general.--Except as provided in paragraph (2), 
        this section shall become effective only if the Secretary 
        certifies to Congress that there is no reasonable likelihood 
        that the implementation of this section would pose any 
        appreciable additional risk to the public health or safety.
            ``(2) Regulations.--Notwithstanding the failure of the 
        Secretary to make a certification under paragraph (1), the 
        Secretary, not later than 30 days after the date of enactment 
        of this paragraph, shall commence a rulemaking for the purpose 
        of formulating regulations to enable the Secretary to implement 
        this section immediately upon making such a certification.''.
    (d) Repeal of Sunset Provision.--Section 804 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384) is amended by striking 
subsection (m).
    (e) Authorization of Appropriations.--Section 804 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 384) (as amended by subsection 
(d)) is amended by adding at the end the following:
    ``(m) Authorization of Appropriations.--There are authorized to be 
appropriated for fiscal year 2002 and each subsequent fiscal year such 
sums as are necessary to carry out this section.''.
                                 <all>