[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H. Con. Res. 420 Introduced in House (IH)]







106th CONGRESS
  2d Session
H. CON. RES. 420

   Providing for corrections in the enrollment of the bill H.R. 4461.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 10, 2000

     Ms. Kaptur (for herself and Mr. Obey) submitted the following 
concurrent resolution; which was referred to the Committee on Commerce, 
and in addition to the Committee on House Administration, 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

_______________________________________________________________________

                         CONCURRENT RESOLUTION


 
   Providing for corrections in the enrollment of the bill H.R. 4461.

    Resolved by the House of Representatives (the Senate concurring), 
That, in the enrollment of the bill (H.R. 4461) making appropriations 
for Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies programs for the fiscal year ending September 30, 
2001, and for other purposes, the Clerk of the House shall strike 
section 745 and insert the following:
    Sec. 745. (a) Short Title.--This section may be cited as the 
``Medicine Equity and Drug Safety Act of 2000''.
    (b) 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 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 en- able such purchases should 
        not endanger the gold standard for safety and effectiveness 
        that has been established and maintained in the United States.
    (c) Imports and Exports.--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.--The Secretary, after consultation with 
        the United States Trade Representative and the Commissioner of 
        Customs, shall promulgate regulations permitting a pharmacist 
        or wholesaler to import into the United States covered 
        products. Such regulations shall be promulgated as 
        expeditiously as possible, but in no case later than two years 
        after the date of the enactment of the Medicine Equity and Drug 
        Safety Act of 2000.
            ``(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 pharmacist or wholesaler 
                importing a covered product complies with the 
                provisions of paragraph (3); and
                    ``(C) contain such additional safeguards as the 
                Secretary may specify in order to ensure the protection 
                of the public health of patients in the United States 
                or to facilitate the importation of covered products.
            ``(3) Information and records.--Regulations promulgated 
        under paragraph (1) shall require such pharmacist or wholesaler 
        to provide information and records to the Secretary, 
        including--
                    ``(A) the name and amount of the active ingredient 
                of the product and description of the dosage form;
                    ``(B) the date that such product is shipped and the 
                quantity of such product that is shipped, the point of 
                origin and the United States consignee of such product, 
                and the price paid for such product;
                    ``(C) documentation from the foreign seller 
                specifying the original source of the product and the 
                amount of each lot of the product originally received;
                    ``(D) the manufacturer's lot or control number of 
                the product imported;
                    ``(E) the name, address, and telephone number of 
                the importer and consignee, including the professional 
                license number of the importer, if the importer is a 
                pharmacist or pharmaceutical wholesaler;
                    ``(F) for a product that is--
                            ``(i) coming from the first foreign 
                        recipient of the product who received such 
                        product from the manufacturer--
                                    ``(I) documentation demonstrating 
                                that such product came from such 
                                recipient and was received by such 
                                recipient from such manufacturer;
                                    ``(II) documentation of the amount 
                                of each lot of the product received by 
                                such recipient to demonstrate that the 
                                amount being imported into the United 
                                States is not more than the amount that 
                                was received by such recipient;
                                    ``(III) documentation demonstrating 
                                that a statistically valid sample of 
                                each lot of the initial imported 
                                shipment was tested at an appropriate 
                                Food and Drug Administration approved 
                                United States laboratory for 
                                authenticity and degradation by the 
                                importer or manufacturer of such 
                                product;
                                    ``(IV) documentation demonstrating 
                                that a statistically valid sample of 
                                all subsequent shipments from such 
                                recipient was tested at an appropriate 
                                Food and Drug Administration approved 
                                United States laboratory for 
                                authenticity and degradation by the 
                                importer or manufacturer of such 
                                product; and
                                    ``(V) certification from the 
                                importer or manufacturer of such 
                                product that the product is approved 
                                for marketing in the United States and 
                                meets all labeling requirements under 
                                this Act; and
                            ``(ii) not coming from the first foreign 
                        recipient of the product, documentation 
                        demonstrating that a statistically valid sample 
                        of each lot was tested for authenticity and 
                        degradation at an appropriate Food and Drug 
                        Administration approved United States 
                        laboratory by the importer or manufacturer of 
                        such product, and meets all labeling 
                        requirements under this Act;
                    ``(G) complete data derived from all tests 
                necessary to assure that the product is in compliance 
                with established specifications and standards, 
                including laboratory records; and
                    ``(H) any other information that the Secretary 
                determines is necessary to ensure the protection of the 
                public health of patients in the United States.
            ``(4) Records maintained by secretary.--Records described 
        in paragraph (3) shall be maintained by the Secretary for a 
        period of time determined to be necessary by the Secretary.
            ``(5) Records maintained by importer.--The pharmacist or 
        wholesaler who imports a covered product as described in 
        paragraph (1) shall maintain records documenting the resale 
        price for such product for a period of time specified by the 
        Secretary. Such records shall be provided upon request to 
        facilitate the studies under this section.
    ``(b) Testing.--
            ``(1) In general.--Testing referred to in subparagraphs (F) 
        and (G) of subsection (a)(3) may be conducted by the pharmacist 
        or wholesaler who is importing such product, or by the 
        manufacturer of the product, in a Food and Drug Administration 
        approved laboratory. Such testing may also be conducted by an 
        independent laboratory under contract with such pharmacist, 
        wholesaler, or manufacturer.
            ``(2) Authentication.--
                    ``(A) In general.--In conducting tests under 
                paragraph (1), the manufacturer of such product shall 
                provide to the pharmacist or wholesaler, information--
                            ``(i) to authenticate such product and 
                        confirm that the labeling of such product 
                        complies with labeling requirements under this 
                        Act; and
                            ``(ii) to indicate if such product is 
                        eligible for importation under this section.
                    ``(B) Confidentiality.--Information supplied under 
                subparagraph (A) and subsection (a)(3)(A) shall not be 
                disclosed for any purpose not authorized by this 
                section. Any person who knowingly and willingly 
                discloses such information for purposes not authorized 
                by this section shall be imprisoned for a period not to 
                exceed 18 months, fined in accordance with title 18, 
                United States Code, or both.
            ``(3) Discretion.--The Secretary may waive or modify 
        testing requirements described under subsection (a)(3) if 
        agreements have been entered into by the Secretary that ensure 
        the safety and effectiveness of the product imported from a 
        specific country, or through a specific distribution chain 
        certified by the Secretary.
    ``(c) Approved Labeling.--The manufacturer of a covered product 
shall provide to the importer involved written authorization for the 
importer to use at no cost the approved labeling for such product.
    ``(d) Non-Discrimination.--No manufacturer of a covered product may 
take actions that discriminate against, or cause other persons to 
discriminate against, United States pharmacists or wholesalers 
regarding the sale or distribution of covered products.
    ``(e) Study and Report.--
            ``(1) Study.--The General Accounting Office shall conduct a 
        study on the imports permitted  under this section, taking into 
consideration the information received under subsection (a). In 
conducting such study, the Office shall--
                    ``(A) evaluate importer's compliance with 
                regulations, determine the number of shipments, if any, 
                permitted under this section that have been determined 
                to be counterfeit, misbranded, or adulterated; and
                    ``(B) consult with the United States Trade 
                Representative and United States Patent and Trademark 
                Office to evaluate the effect of importations permitted 
                under this Act on trade and patent rights under Federal 
                law.
            ``(2) Report.--Not later than 5 years after the effective 
        date of final regulations issued pursuant to this section, the 
        General Accounting Office shall prepare and submit to Congress 
        a report containing the study described in paragraph (1).
    ``(f) 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 subsection (a).
    ``(g) Definitions.--In this section:
            ``(1) Covered product.--
                    ``(A) In general.--The term `covered product' means 
                a prescription drug product under section 503(b)(1) 
                that meets the applicable requirements of section 505, 
                and is approved by the Food and Drug Administration and 
                manufactured in a facility identified in the approved 
                application and is not adulterated under section 501 or 
                misbranded under section 502.
                    ``(B) Charitable contributions; parenteral drugs.--
                Notwithstanding any other provision of this section, 
                section 801(d)(1)--
                            ``(i) continues to apply to a covered 
                        product donated at no cost by the manufacturer 
                        of the drug to a charitable or humanitarian 
                        organization, including the United Nations and 
                        affiliates, or to a government of a foreign 
                        country; and
                            ``(ii) continues to apply to a covered 
                        product that is a parenteral drug the 
                        importation of which pursuant to subsection (a) 
                        is determined by the Secretary to pose a threat 
                        to the public health.
            ``(2) Pharmacist.--The term `pharmacist' means a person 
        licensed to practice pharmacy under State law, including the 
        dispensing and selling of prescription drugs, or an entity 
        licensed or otherwise authorized as a pharmacy under State law.
            ``(3) Wholesaler.--The term `wholesaler' means a person 
        licensed as a wholesaler or distributor of prescription drug 
        products in the United States pursuant to section 503(e)(2)(A).
            ``(4) Discrimination.--The term `discrimination' includes 
        with respect to United States pharmacists or wholesalers a 
        contract provision, a limitation on supply, or other measure 
        which has the effect of providing U.S. pharmacists or 
        wholesalers access to covered products on terms or conditions 
        that are less favorable than the terms or conditions provided 
        to any foreign purchaser (other than a charitable purchaser) of 
        such products, or otherwise has the effect of restricting the 
        access of United States pharmacists or wholesalers to 
        prescription drugs that can be imported into the United States 
        under this section.
    ``(h) Funding.--For the purpose of carrying out this section--
            ``(1) there is hereby appropriated, out of any money in the 
        Treasury not otherwise appropriated, $23,000,000 for fiscal 
        year 2001; and
            ``(2) there are authorized to be appropriated for fiscal 
        year 2002 and each subsequent fiscal year such sums as may be 
        necessary.
    ``(i) Conditions.--Regulations promulgated under subsection (a)(1) 
shall become effective only if the Secretary certifies to the Congress 
that the implementation of this section will pose no greater risk to 
the public's health and safety than would otherwise apply.''.
    (d) Prohibited Act.--
            (1) In general.--Section 301 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 331) is amended by adding at the end 
        the following:
    ``(aa) The importation of a covered product in violation of section 
804, the falsification of any record required to be maintained or 
provided to the Secretary under such section, or any other violation of 
requirements under such section.''.
            (2) Enhanced penalties.--Section 303(b) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 333(b)) is amended by 
        adding at the end the following:
    ``(6) Notwithstanding subsection (a), any person who is a 
manufacturer or importer of a covered product pursuant to section 
804(a) and knowingly fails to comply with a requirement of subsection 
(b), (c), or (d) of section 804 that is applicable to such manufacturer 
or importer, respectively, shall be imprisoned for not more than 10 
years or fined not more than $1,000,000, or both.''.
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