article: SECTION 1. SHORT TITLE; TABLE OF CONTENTS. (a) Short Title.--This Act may be cited as the ``Generic Pharmaceutical Access and Choice for Consumers Act of 2000''. (b) Table of Contents.--The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Findings and purposes. TITLE I--ENCOURAGEMENT OF THE USE OF GENERIC DRUGS Sec. 101. Encouragement of the use of generic drugs under the Public Health Service Act. Sec. 102. Application to Federal employees health benefits program. Sec. 103. Application to medicare program. Sec. 104. Application to medicaid program. Sec. 105. Application to Indian Health Service. Sec. 106. Application to veterans programs. Sec. 107. Application to recipients of uniformed services health care. Sec. 108. Application to Federal prisoners. TITLE II--THERAPEUTIC EQUIVALENCE REQUIREMENTS FOR GENERIC DRUGS Sec. 201. Therapeutic equivalence of generic drugs. TITLE III--GENERIC PHARMACEUTICALS AND MEDICARE REFORM Sec. 301. Sense of the Senate regarding a preference for the use of generic pharmaceuticals under the medicare program. SEC. 2. FINDINGS AND PURPOSES. (a) Findings.--Congress makes the following findings: (1) Generic pharmaceuticals are approved by the Food and Drug Administration on the basis of testing and other information establishing that such pharmaceuticals are therapeutically equivalent to brand-name pharmaceuticals, ensuring consumers a safe, efficacious, and cost-effective alternative to brand-name pharmaceuticals. (2) The pharmaceutical market has become increasingly competitive during the last decade because of the increasing availability and accessibility of generic pharmaceuticals. (3) The Congressional Budget Office estimates that-- (A) the substitution of generic pharmaceuticals for brand-name pharmaceuticals will save purchasers of pharmaceuticals between $8,000,000,000 and $10,000,000,000 each year; and (B) quality generic pharmaceuticals cost between 25 percent and 60 percent less than brand-name pharmaceuticals, resulting in an estimated average savings of $15 to $30 on each prescription filled. (4) Generic pharmaceuticals are widely accepted by both consumers and the medical profession, as the market share held by generic pharmaceuticals compared to brand-name pharmaceuticals has more than doubled during the last decade, from approximately 19 percent to 43 percent, according to the Congressional Budget Office. (b) Purposes.--The purposes of this Act are-- (1) to reduce the cost of prescription drugs to the United States Government and to beneficiaries under Federal health care programs while maintaining the quality of health care by encouraging the use of generic drugs rather than nongeneric drugs under those programs whenever feasible; and (2) to increase the utilization of generic pharmaceuticals by requiring the Food and Drug Administration, where appropriate, to determine that a generic pharmaceutical is the therapeutic equivalent of its brand-name counterpart, and by affording national uniformity to that determination. TITLE I--ENCOURAGEMENT OF THE USE OF GENERIC DRUGS SEC. 101. ENCOURAGEMENT OF THE USE OF GENERIC DRUGS UNDER THE PUBLIC HEALTH SERVICE ACT. (a) In General.--Part B of title II of the Public Health Service Act (42 U.S.C. 238 et seq.) is amended by adding at the end the following new section: ``SEC. 247. USE OF GENERIC DRUGS ENCOURAGED. ``(a) Each grant or contract entered into under this Act that involves the provision of health care items or services to individuals shall include provisions to ensure that, to the extent feasible, any prescriptions provided for under such grant or contract are filled by providing the generic form of the drug involved, unless the nongeneric form of the drug is-- ``(1) specifically ordered by the prescribing provider; or ``(2) requested by the individual for whom the drug is prescribed. ``(b) In this section: ``(1) The term `generic form of the drug' means a drug that is the subject of an application approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), for which the Secretary has made a determination that the drug is the therapeutic equivalent of a listed drug under section 505(j)(5)(E) of that Act (21 U.S.C. 355(j)(5)(E)). ``(2) The term `nongeneric form of the drug' means a drug that is the subject of an application approved under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)).''. (b) Effective Date.--The amendment made by this section shall apply with respect to any drug furnished on or after the date of enactment of this Act. SEC. 102. APPLICATION TO FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM. (a) In General.--Section 8902 of title 5, United States Code, is amended by adding at the end the following new subsection: ``(p) To the extent feasible, if a contract under this chapter provides for the provision of, the payment for, or the reimbursement of the cost of any prescription drug, the carrier shall provide, pay, or reimburse the cost of the generic form of the drug (as defined in section 247(b)(1) of the Public Health Service Act), except, if the nongeneric form of the drug (as defined in section 247(b)(2) of such Act) is-- ``(1) specifically ordered by the prescribing provider; or ``(2) requested by the individual for whom the drug is prescribed.''. (b) Effective Date.--The amendment made by this section shall apply to any drug furnished during contract years beginning on or after January 1, 2001. SEC. 103. APPLICATION TO MEDICARE PROGRAM. (a) In General.--Section 1861(t) of the Social Security Act (42 U.S.C. 1395x(t)) is amended by adding at the end the following new paragraph: ``(3) For purposes of paragraph (1), the term `drugs' means, to the extent feasible, the generic form of the drug (as defined in section 247(b)(1) of the Public Health Service Act), unless the nongeneric form of such drug (as defined in section 247(b)(2) of such Act) is-- ``(A) specifically ordered by the health care provider; or ``(B) requested by the individual to whom the drug is provided.''. (b) Effective Date.-- (1) In general.--Except as provided in paragraph (2), the amendment made by this section shall apply with respect to any drug furnished on or after the date of enactment of this Act. (2) Medicare+choice plans.--In the case of a Medicare+Choice plan offered by a Medicare+Choice organization under part C of title XVIII of the Social Security Act (42 U.S.C. 1395w-21 et seq.), the amendment made by this section shall apply to any drug furnished during contract years beginning on or after January 1, 2001. SEC. 104. APPLICATION TO MEDICAID PROGRAM. (a) In General.--Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)) is amended-- (1) in paragraph (64), by striking ``and'' at the end; (2) in paragraph (65), by striking the period at the end and inserting ``; and''; and (3) by adding the following new paragraph: ``(66) provide that the State shall, in conjunction with the program established under section 1927(g), to the extent feasible, provide for the use of a generic form of a drug (as defined in section 247(b)(1) of the Public Health Service Act), unless the nongeneric form of the drug (as defined in section 247(b)(2) of such Act is-- ``(A) specifically ordered by the provider; or ``(B) requested by the individual to whom the drug is provided.''. (b) Effective Date.--The amendment made by this section shall apply with respect to any drug furnished under State plans that are approved or renewed on or after the date of enactment of this Act. SEC. 105. APPLICATION TO INDIAN HEALTH SERVICE. (a) In General.--Title II of the Indian Health Care Improvement Act (25 U.S.C. 1621 et seq.) is amended by adding at the end the following new subsection: ``SEC. 225. USE OF GENERIC DRUGS ENCOURAGED. ``In providing health care items or services under this Act, the Indian Health Service shall ensure that, to the extent feasible, any prescriptions that are provided for under this Act are filled by providing the generic form of the drug (as defined in section 247(b)(1) of the Public Health Service Act) involved, unless the nongeneric form of the drug (as defined in section 247(b)(2) of such Act) is-- ``(1) specifically ordered by the prescribing provider; or ``(2) requested by the individual for whom the drug is prescribed.''. (b) Effective Date.--The amendment made by this section shall apply with respect to any drug furnished on or after the date of enactment of this Act. SEC. 106. APPLICATION TO VETERANS PROGRAMS. (a) Use of Generic Drugs Encouraged.--Subchapter III of chapter 17 of title 38, United States Code, is amended by inserting after section 1722A the following new section: ``Sec. 1722B. Use of generic drugs encouraged ``When furnishing a prescription drug under this chapter, the Secretary shall furnish a generic form of the drug (as defined in section 247(b)(1) of the Public Health Service Act), unless the nongeneric form of the drug (as defined in section 247(b)(2) of such Act) is-- ``(1) specifically ordered by the prescribing provider; or ``(2) requested by the individual for whom the drug is prescribed.''. (b) Clerical Amendment.--The table of sections at the beginning of chapter 17 of such title is amended by inserting after the item relating to section 1722A the following new item: ``1722B. Use of generic drugs encouraged.''. (c) Effective Date.--The amendments made by this section shall apply with respect to any drug furnished on or after the date of enactment of this Act. SEC. 107. APPLICATION TO RECIPIENTS OF UNIFORMED SERVICES HEALTH CARE. (a) Use of Generic Drugs Encouraged.--Chapter 55 of title 10, United States Code, is amended by adding at the end the following new section: ``Sec. 1110. Use of generic drugs encouraged ``The Secretary of Defense shall ensure that, whenever feasible, each health care provider who furnishes a drug furnishes the generic form of the drug (as defined in section 247(b)(1) of the Public Health Service Act), unless the nongeneric form of the drug (as defined in section 247(b)(2) of such Act) is-- ``(1) specifically ordered by the prescribing provider; or ``(2) requested by the individual for whom the drug is prescribed.''. (b) Clerical Amendment.--The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 1109 the following new item: ``1110. Use of generic drugs encouraged.''. (c) Effective Date.--The amendments made by this section shall apply with respect to any drug furnished on or after the date of enactment of this Act. SEC. 108. APPLICATION TO FEDERAL PRISONERS. (a) In General.--Section 4006(b) of title 18, United States Code, is amended by adding at the end the following new paragraph: ``(3) Use of generic drugs encouraged.--The Attorney General shall ensure that, whenever feasible, each health care provider who furnishes a drug to a prisoner charged with or convicted of an offense against the United States furnishes the generic form of the drug (as defined in section 247(b)(1) of the Public Health Service Act), unless the nongeneric form of the drug (as defined in section 247(b)(2) of such Act) is-- ``(A) specifically ordered by the prescribing provider; or ``(B) requested by the prisoner for whom the drug is prescribed.''. (b) Effective Date.--The amendment made by this section shall apply with respect to any drug furnished on or after the date of enactment of this Act. TITLE II--THERAPEUTIC EQUIVALENCE REQUIREMENTS FOR GENERIC DRUGS SEC. 201. THERAPEUTIC EQUIVALENCE OF GENERIC DRUGS. (a) In General.--Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended-- (1) in paragraph (5), by adding at the end the following new subparagraph: ``(E)(i) For each abbreviated application filed under paragraph (1), the Secretary shall determine whether the new drug for which the application is filed is the therapeutic equivalent of the listed drug referred to in paragraph (2)(A)(i) prior to the approval of the application. ``(ii) For purposes of clause (i), a new drug is the therapeutic equivalent of a listed drug if-- ``(I) each active ingredient of the new drug and the listed drug is the same; ``(II) the new drug and the listed drug (aa) are of the same dosage form; (bb) have the same route of administration; (cc) are identical in strength or concentration; (dd) meet the same compendial or other applicable standards, except that the drugs may differ in shape, scoring, configuration, packaging, excipient, expiration time, or, subject to paragraph (2)(A)(v), labeling; and (ee) are expected to have the same clinical effect and safety profile when administered to patients under conditions specified in the labeling; and ``(III) the new drug does not (aa) present a known or potential bioequivalence problem and meets an acceptable in vitro standard; or (bb) if the new drug presents a known or potential bioequivalence problem, the drug is shown to meet an appropriate bioequivalence standard. ``(iii) With respect to a new drug for which an abbreviated application is filed under paragraph (1), the provisions of this subparagraph shall supersede any provisions of the law of any State relating to the determination of the therapeutic equivalence of the drug to a listed drug.''; and (2) in paragraph (7)(A), by adding at the end the following: ``(iv) The Secretary shall include in each revision of the list under clause (ii) on or after the date of enactment of this clause the official and proprietary name of each listed drug that is therapeutically equivalent to a new drug approved under this subsection during the preceding 30-day period, as determined under paragraph (5)(E).''. (b) Effective Date.--The amendments made by this section shall take effect on the date of enactment of this Act. TITLE III--GENERIC PHARMACEUTICALS AND MEDICARE REFORM SEC. 301. SENSE OF THE SENATE REGARDING A PREFERENCE FOR THE USE OF GENERIC PHARMACEUTICALS UNDER THE MEDICARE PROGRAM. It is the sense of the Senate that legislative language requiring, to the extent feasible, a preference for the safe and cost-effective use of generic pharmaceuticals should be considered in conjunction with any legislation that adds a comprehensive prescription drug benefit to the medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).
summary: Makes similar changes under the Federal Employee Health Benefits program, Medicare program, Medicaid program, and programs affecting Indians, veterans, the uniformed services, and prisoners. Title II: Therapeutic Equivalence Requirements for Generic Drugs - Amends the Federal Food, Drug, and Cosmetic Act to require that for each abbreviated drug application file there shall be a determination as to whether the new drug for which the application is filed is the therapeutic equivalent of a listed drug prior to the approval of the application. Title III: Generic Pharmaceuticals and Medicare Reform - Expresses the sense of the Senate that legislative language requiring, to the extent feasible, a preference for the safe and cost-effective use of generic pharmaceuticals should be considered in conjunction with any legislation that adds a comprehensive prescription drug benefit to the Medicare program.