text: 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.).
target: 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.
feat_title: Generic Pharmaceutical Access and Choice for Consumers Act of 2000