[Congressional Record (Bound Edition), Volume 148 (2002), Part 10]
[Senate]
[Pages 14233-14235]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 4316. Mr. ROCKEFELLER (for himself, Ms. Collins, Mr. Nelson of 
Nebraska, Mr. Smith of Oregon, Mrs. Lincoln, Mr. Durbin, Mr. Corzine, 
Mr. Harkin Mr. Murkowski, Mr. Hutchinson, Mrs. Clinton, Mr. Torricelli, 
Mr. Wellstone, Mr. Schumer, Ms. Mikulski, Mr. Kerry, Ms. Landrieu, Mr. 
Bingaman, Mrs. Feinstein, Mrs. Murray, Ms. Snowe, Mr. Enzi, Mr. 
Johnson, Mr. Sarbanes, Mr. Dayton, Mr. Leahy, Ms. Cantwell, Mr. Bayh, 
Mr. Kennedy, Mr. Jeffords, Mr. Cleland, Mr. Miller, and Mr. Cochran) 
proposed an amendment to amendment SA 4299 proposed by Mr. Reid (for 
Mr. Dorgan (for himself, Mr. Wellstone, Mr. Jeffords, Ms. Stabenow, Ms. 
Collins, Mr. Levin, Mr. Johnson, Mr. Miller, Mr. Durbin, Mr. Feingold, 
and Mr. Harkin)) to the bill (S. 812) to amend the Federal Food, Drug, 
and Co:

       At the appropriate place, insert the following:

     SEC. __. TEMPORARY STATE FISCAL RELIEF.

       (a) Temporary Increase of Medicaid FMAP.--
       (1) Permitting maintenance of fiscal year 2001 fmap for 
     last 2 calendar quarters of fiscal year 2002.--
     Notwithstanding any other provision of law, but subject to 
     paragraph (5), if the FMAP determined without regard to this 
     subsection for a State for fiscal year 2002 is less than the 
     FMAP as so determined for fiscal year 2001, the FMAP for the 
     State for fiscal year 2001 shall be substituted for the 
     State's FMAP for the third and fourth calendar quarters of 
     fiscal year 2002, before the application of this subsection.
       (2) Permitting maintenance of fiscal year 2002 fmap for 
     fiscal year 2003.--Notwithstanding any other provision of 
     law, but subject to paragraph (5), if the FMAP determined 
     without regard to this subsection for a State for fiscal year 
     2003 is less than the FMAP as so determined for fiscal year 
     2002, the FMAP for the State for fiscal year 2002 shall be 
     substituted for the State's FMAP for each calendar quarter of 
     fiscal year 2003, before the application of this subsection.
       (3) General 1.35 percentage points increase for last 2 
     calendar quarters of fiscal year 2002 and fiscal year 2003.--
     Notwithstanding any other provision of law, but subject to 
     paragraphs (5) and (6), for each State for the third and 
     fourth calendar quarters of fiscal year 2002 and each 
     calendar quarter of fiscal year 2003, the FMAP (taking into 
     account the application of paragraphs (1) and (2)) shall be 
     increased by 1.35 percentage points.
       (4) Increase in cap on medicaid payments to territories.--
     Notwithstanding any other provision of law, but subject to 
     paragraph (6), with respect to the third and fourth calendar 
     quarters of fiscal year 2002 and each calendar quarter of 
     fiscal year 2003, the amounts otherwise determined for Puerto 
     Rico, the Virgin Islands, Guam, the Northern Mariana Islands, 
     and American Samoa under subsections (f) and (g) of section 
     1108 of the Social Security Act (42 U.S.C. 1308) shall each 
     be increased by an amount equal to 2.7 percent of such 
     amounts.
       (5) Scope of application.--The increases in the FMAP for a 
     State under this subsection shall apply only for purposes of 
     title XIX of the Social Security Act and shall not apply with 
     respect to--
       (A) disproportionate share hospital payments described in 
     section 1923 of such Act (42 U.S.C. 1396r-4); or
       (B) payments under title IV or XXI of such Act (42 U.S.C. 
     601 et seq. and 1397aa et seq.).
       (6) State eligibility.--
       (A) In general.--Subject to subparagraph (B), a State is 
     eligible for an increase in its FMAP under paragraph (3) or 
     an increase in a cap amount under paragraph (4) only if the 
     eligibility under its State plan under title XIX of the 
     Social Security Act (including any waiver under such title or 
     under section 1115 of such Act (42 U.S.C. 1315)) is no more 
     restrictive than the eligibility under such plan (or waiver) 
     as in effect on January 1, 2002.
       (B) State reinstatement of eligibility permitted.--A State 
     that has restricted eligibility under its State plan under 
     title XIX of the Social Security Act (including any waiver 
     under such title or under section 1115 of such Act (42 U.S.C. 
     1315)) after January 1, 2002, but prior to the date of 
     enactment of this Act is eligible for an increase in its FMAP 
     under paragraph (3) or an increase in a cap amount under 
     paragraph (4) in the first calendar quarter (and subsequent 
     calendar quarters) in which the State has reinstated 
     eligibility that is no more restrictive than the eligibility 
     under such plan (or waiver) as in effect on January 1, 2002.
       (C) Rule of construction.--Nothing in subparagraph (A) or 
     (B) shall be construed as affecting a State's flexibility 
     with respect to benefits offered under the State medicaid 
     program under title XIX of the Social Security Act (42 U.S.C. 
     1396 et seq.) (including any waiver under such title or under 
     section 1115 of such Act (42 U.S.C. 1315)).
       (7) Definitions.--In this subsection:
       (A) FMAP.--The term ``FMAP'' means the Federal medical 
     assistance percentage, as defined in section 1905(b) of the 
     Social Security Act (42 U.S.C. 1396d(b)).
       (B) State.--The term ``State'' has the meaning given such 
     term for purposes of title XIX of the Social Security Act (42 
     U.S.C. 1396 et seq.).
       (8) Repeal.--Effective as of October 1, 2003, this 
     subsection is repealed.
       (b) Additional Temporary State Fiscal Relief.--
       (1) In general.--Title XX of the Social Security Act (42 
     U.S.C. 1397-1397f) is amended by adding at the end the 
     following:

     ``SEC. 2008. ADDITIONAL TEMPORARY GRANTS FOR STATE FISCAL 
                   RELIEF.

       ``(a) In General.--For the purpose of providing State 
     fiscal relief allotments to States under this section, there 
     are hereby appropriated, out of any funds in the Treasury not 
     otherwise appropriated, $3,000,000,000. Such funds shall be 
     available for obligation by the State through June 30, 2004, 
     and for expenditure by the State through September 30, 2004. 
     This section constitutes budget authority in advance of 
     appropriations Acts and represents the obligation of the 
     Federal Government to provide for the payment to States of 
     amounts provided under this section.
       ``(b) Allotment.--Funds appropriated under subsection (a) 
     shall be allotted by the Secretary among the States in 
     accordance with the following table:

       

------------------------------------------------------------------------
               ``State                       Allotment (in dollars)
------------------------------------------------------------------------
 Alabama                                $33,918,100
 Alaska                                 $8,488,200
 Amer. Samoa                            $88,600
 Arizona                                $47,601,600
 Arkansas                               $27,941,800
 California                             $314,653,900
 Colorado                               $27,906,200
 Connecticut                            $41,551,200
 Delaware                               $8,306,000
 District of Columbia                   $12,374,400
 Florida                                $128,271,100
 Georgia                                $69,106,600
 Guam                                   $135,900
 Hawaii                                 $9,914,700
 Idaho                                  $10,293,600
 Illinois                               $102,577,900
 Indiana                                $50,659,800
 Iowa                                   $27,799,700
 Kansas                                 $21,414,300
 Kentucky                               $44,508,400
 Louisiana                              $50,974,000
 Maine                                  $17,841,100
 Maryland                               $44,228,800
 Massachusetts                          $100,770,700
 Michigan                               $91,196,800
 Minnesota                              $57,515,400
 Mississippi                            $35,978,500
 Missouri                               $62,189,600
 Montana                                $8,242,000
 Nebraska                               $16,671,600
 Nevada                                 $10,979,700
 New Hampshire                          $10,549,400
 New Jersey                             $87,577,300
 New Mexico                             $21,807,600
 New York                               $461,401,900
 North Carolina                         $79,538,300
 North Dakota                           $5,716,900
 N. Mariana Islands                     $50,000
 Ohio                                   $116,367,800
 Oklahoma                               $30,941,800
 Oregon                                 $34,327,200
 Pennsylvania                           $159,089,700
 Puerto Rico                            $3,991,900
 Rhode Island                           $16,594,100
 South Carolina                         $38,238,000
 South Dakota                           $6,293,700
 Tennessee                              $81,120,000
 Texas                                  $159,779,800
 Utah                                   $12,551,700
 Vermont                                $8,003,800
 Virgin Islands                         $128,800
 Virginia                               $44,288,300
 Washington                             $66,662,200
 West Virginia                          $19,884,400
 Wisconsin                              $47,218,900
 Wyoming                                $3,776,400
------------------------------------------------------------------------
 Total                                  $3,000,000,000
------------------------------------------------------------------------


[[Page 14234]]

       ``(c) Use of Funds.--Funds appropriated under this section 
     may be used by a State for services directed at the goals set 
     forth in section 2001, subject to the requirements of this 
     title.
       ``(d) Payment to States.--Not later than 30 days after 
     amounts are appropriated under subsection (a), in addition to 
     any payment made under section 2002 or 2007, the Secretary 
     shall make a lump sum payment to a State of the total amount 
     of the allotment for the State as specified in subsection 
     (b).
       ``(e) Definition.--For purposes of this section, the term 
     `State' means the 50 States, the District of Columbia, and 
     the territories contained in the list under subsection 
     (b).''.
       (2) Repeal.--Effective as of January 1, 2005, section 2008 
     of the Social Security Act, as added by paragraph (1), is 
     repealed.
       (c) Emergency Designation.--The entire amount necessary to 
     carry out this section is designated by Congress as an 
     emergency requirement pursuant to section 252(e) of the 
     Balanced Budget and Emergency Deficit Control Act of 1985 (2 
     U.S.C. 902(e)).

  SA 4317. Mrs. CLINTON (for herself, Mr. DeWine, Mr. Dodd, and Mr. 
Bingaman) submitted an amendment intended to be proposed by her to the 
bill S. 812, to amend the Federal Food, Drug, and Cosmetic Act to 
provide greater access to affordable pharmaceuticals; which was ordered 
to lie on the table; as follows:
       At the appropriate place, insert the following:

     SEC. __. PEDIATRIC LABELING OF DRUGS AND BIOLOGICAL PRODUCTS

       (a) In General.--Subchapter A of chapter V of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is 
     amended by inserting after section 505A the following:

     ``SEC. 505B. PEDIATRIC LABELING OF DRUGS AND BIOLOGICAL 
                   PRODUCTS.

       ``(a) New Drugs and Biological Products.--
       ``(1) In general.--A person that submits an application (or 
     supplement to an application)--
       ``(A) under section 505 for a new active ingredient, new 
     indication, new dosage form, new dosing regimen, or new route 
     of administration; or
       ``(B) under section 351 of the Public Health Service Act 
     (42 U.S.C. 262) for a biological product license;
     shall submit with the application the assessments described 
     in paragraph (2).
       ``(2) Assessments.--
       ``(A) In general.--The assessments referred to in paragraph 
     (1) shall contain data, gathered using appropriate 
     formulations, that are adequate--
       ``(i) to assess the safety and effectiveness of the drug, 
     or the biological product licensed under section 351 of the 
     Public Health Service Act (42 U.S.C. 262), for the claimed 
     indications in all relevant pediatric subpopulations; and
       ``(ii) to support dosing and administration for each 
     pediatric subpopulation for which the drug, or the biological 
     product licensed under section 351 of the Public Health 
     Service Act (42 U.S.C. 262), is safe and effective.
       ``(B) Similar course of disease or similar effect of drug 
     or biological product.--If the course of the disease and the 
     effects of the drug are sufficiently similar in adults and 
     pediatric patients, the Secretary may conclude that pediatric 
     effectiveness can be extrapolated from adequate and well-
     controlled studies in adults, usually supplemented with other 
     information obtained in pediatric patients, such as 
     pharmacokinetic studies.
       ``(3) Deferral.--On the initiative of the Secretary or at 
     the request of the applicant, the Secretary may defer 
     submission of some or all assessments required under 
     paragraph (1) until a specified date after approval of the 
     drug or issuance of the license for a biological product if--
       ``(A) the Secretary finds that--
       ``(i) the drug or biological product is ready for approval 
     for use in adults before pediatric studies are complete; or
       ``(ii) pediatric studies should be delayed until additional 
     safety or effectiveness data have been collected; and
       ``(B) the applicant submits to the Secretary--
       ``(i) a certified description of the planned or ongoing 
     studies; and
       ``(ii) evidence that the studies are being conducted or 
     will be conducted with due diligence.
       ``(b) Marketed Drugs and Biological Products.--After 
     providing notice and an opportunity for written response and 
     a meeting, which may include an advisory committee meeting, 
     the Secretary may by order require the holder of an approved 
     application relating to a drug under section 505 or the 
     holder of a license for a biological product under section 
     351 of the Public Health Service Act (42 U.S.C. 262) to 
     submit by a specified date the assessments described in 
     subsection (a) if the Secretary finds that--
       ``(1)(A) the drug or biological product is used for a 
     substantial number of pediatric patients for the labeled 
     indications; and
       ``(B) the absence of adequate labeling could pose 
     significant risks to pediatric patients; or
       ``(2)(A) there is reason to believe that the drug or 
     biological product would represent a meaningful therapeutic 
     benefit over existing therapies for pediatric patients for 1 
     or more of the claimed indications; and
       ``(B) the absence of adequate labeling could pose 
     significant risks to pediatric patients.
       ``(c) Delay in Submission of Assessments.--If a person 
     delays the submission of assessments relating to a drug or 
     biological product beyond a date specified in subsection (a) 
     or (b)--
       ``(1) the drug or biological product--
       ``(A) shall be deemed to be misbranded;
       ``(B) shall be subject to action under sections 302 and 
     304; and
       ``(C) shall not be subject to action under section 303; and
       ``(2) the delay shall not be the basis for a proceeding to 
     withdraw approval for a drug under section 505(e) or revoke 
     the license for a biological product under section 351 of the 
     Public Health Service Act (42 U.S.C. 262).
       ``(d) Waivers.--
       ``(1) Full waiver.--At the request of an applicant, the 
     Secretary shall grant a full waiver, as appropriate, of the 
     requirement to submit assessments under subsection (a) or (b) 
     if--
       ``(A) necessary studies are impossible or highly 
     impracticable;
       ``(B) there is evidence strongly suggesting that the drug 
     or biological product would be ineffective or unsafe in all 
     pediatric age groups; or
       ``(C)(i) the drug or biological product--
       ``(I) does not represent a meaningful therapeutic benefit 
     over existing therapies for pediatric patients; and
       ``(II) is not likely to be used for a substantial number of 
     pediatric patients; and
       ``(ii) the absence of adequate labeling would not pose 
     significant risks to pediatric patients.
       ``(2) Partial waiver.--At the request of an applicant, the 
     Secretary shall grant a partial waiver, as appropriate, of 
     the requirement to submit assessments under subsection (a) 
     with respect to a specific pediatric subpopulation if--
       ``(A) any of the grounds stated in paragraph (1) applies to 
     that subpopulation; or
       ``(B) the applicant demonstrates that reasonable attempts 
     to produce a pediatric formulation necessary for that 
     subpopulation have failed.
       ``(3) Labeling requirement.--If the Secretary grants a full 
     or partial waiver because there is evidence that a drug or 
     biological product would be ineffective or unsafe in 
     pediatric populations, the information shall be included in 
     the labeling for the drug or biological product.
       ``(e) Meetings.--The Secretary shall meet at appropriate 
     times in the investigational new drug process with the 
     sponsor to discuss background information that the sponsor 
     shall submit on plans and timelines for pediatric studies, or 
     any planned request for waiver or deferral of pediatric 
     studies.''.
       (b) Conforming Amendments.--
       (1) Section 505(b)(1) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(b)(1)) is amended in the second 
     sentence--
       (A) by striking ``and (F)'' and inserting ``(F)''; and
       (B) by striking the period at the end and inserting ``, and 
     (G) any assessments required under section 505B.''.
       (2) Section 505A(h) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355a(h)) is amended--
       (A) in the subsection heading, by striking ``Regulations'' 
     and inserting ``Pediatric Study Requirements''; and
       (B) by striking ``pursuant to regulations promulgated by 
     the Secretary'' and inserting ``by a provision of law 
     (including a regulation) other than this section''.
       (3) Section 351(a)(2) of the Public Health Service Act (42 
     U.S.C. 262(a)(2)) is amended--
       (A) by redesignating subparagraph (B) as subparagraph (C); 
     and
       (B) by inserting after subparagraph (A) the following:
       ``(B) Pediatric studies.--A person that submits an 
     application for a license under this paragraph shall submit 
     to the Secretary as part of the application any assessments 
     required under section 505B of the Federal Food, Drug, and 
     Cosmetic Act.''.
       (c) Final Rule.--Except to the extent that the final rule 
     is inconsistent with the amendment made by subsection (a), 
     the final rule promulgating regulations requiring 
     manufacturers to assess the safety and effectiveness of new 
     drugs and biological products in pediatric patients (63 Fed. 
     Reg. 66632 (December 2, 1998)), shall be considered to 
     implement the amendment made by subsection (a).
       (d) No Effect on Authority.--Section 505B of the Federal 
     Food, Drug, and Cosmetic Act (as added by subsection (a)) 
     does not affect whatever existing authority the Secretary of 
     Health and Human Services has to require pediatric 
     assessments regarding the safety and efficacy of drugs and 
     biological products in addition to the assessments required 
     under that section. The authority, if any, of the Secretary 
     of Health and Human Services regarding specific populations 
     other than the pediatric population shall be exercised in 
     accordance with the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 301 et seq.) as in effect on the day before the date 
     of enactment of this Act.

  SA 4318. Mrs. CLINTON submitted an amendment intended to be proposed 
by

[[Page 14235]]

her to the bill S. 812, to amend the Federal Food, Drug, and Cosmetic 
Act to provide greater access to affordable pharmaceuticals; which was 
ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

       TITLE __--ETHICAL PRESCRIPTION DRUG MARKETING ACT OF 2002

     SEC. __1. SHORT TITLE.

       This title may be cited as the ``Ethical Prescription Drug 
     Marketing Act of 2002''.

     SEC. __2. PROHIBITION ON OFFERING OR PROVIDING ITEMS OR 
                   SERVICES FROM DRUG MANUFACTURERS TO HEALTH CARE 
                   PROFESSIONALS.

       Section 503 of the Federal Food, Drug, and Cosmetics Act 
     (21 U.S.C. 353) is amended by adding at the end the 
     following:
       ``(h)(1) A drug manufacturer shall not offer or provide any 
     item or service to a health care professional in a manner or 
     on a condition that would interfere with the independence of 
     the health care professional's prescribing practices.
       ``(2)(A) A drug manufacturer shall not offer or provide any 
     money (including cash or a cash equivalent) to a health care 
     professional, except as compensation under an arrangement for 
     bona fide services, such as services as a consultant, as a 
     participant in speaker training meetings, or as a researcher.
       ``(B) A drug manufacturer shall not offer or provide any 
     non-monetary item or service to a health care professional 
     intended primarily for the personal benefit of the health 
     care professional.
       ``(C) A drug manufacturer shall not offer or provide any 
     non-monetary item or service, of substantial value, to a 
     health care professional, except that a drug manufacturer may 
     distribute a drug sample in compliance with subsection (d).
       ``(3) Each drug manufacturer shall be subject to a civil 
     monetary penalty of not more than $10,000 for each violation 
     of this subsection. Each unlawful offer or provision shall 
     constitute a separate violation. The provisions of paragraphs 
     (3), (4), and (5) of section 303(g) shall apply to such a 
     violation in the same manner as such provisions apply to a 
     violation of a requirement of this Act that relates to 
     devices.
       ``(4)(A) For purposes of this subsection, an arrangement 
     between a drug manufacturer and a health care professional 
     for the services of the health care professional shall be 
     considered to be an arrangement for bona fide services if, of 
     the factors described in subparagraph (B), the factors that 
     are relevant to the arrangement are present.
       ``(B) The factors referred to in subparagraph (A) are--
       ``(i) a legitimate need for the services, identified in 
     advance of requesting the services and entering into the 
     arrangement;
       ``(ii) a written contract specifying the nature of the 
     services and the basis for payment for those services;
       ``(iii) selection of the health care professional to 
     provide the services, based on criteria directly related to 
     the identified need, and conducted by a person with the 
     expertise necessary to evaluate whether health care 
     professionals meet the criteria;
       ``(iv) a number of health care professionals retained under 
     the arrangement that is not greater than the number 
     reasonably necessary to address the identified need;
       ``(v) maintenance of appropriate records concerning, and 
     appropriate use of the services of, the health care 
     professional; and
       ``(vi) a venue and circumstances for any meeting that is 
     conducive to providing the services, with any social or 
     entertainment events at the meeting clearly subordinate to 
     the provision of the services.
       ``(5) In this subsection:
       ``(A) The term `drug manufacturer' means--
       ``(i) a person who manufactures a prescription drug 
     approved under section 505 or a biological product licensed 
     under section 351 of the Public Health Service Act (42 U.S.C. 
     262); or
       ``(ii) a person who is licensed by a person described in 
     clause (i) to distribute or market such a drug or biological 
     product.
       ``(B) The term `health care professional' means a 
     physician, or other individual who is a provider of health 
     care, who is licensed under the law of a State to prescribe 
     drugs.
       ``(C) The term `substantial value' means $100 or more.''.

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