[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11311-11314]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 1034. Mr. DURBIN (for himself and Mr. Bingaman) submitted an 
amendment intended to be proposed by him to the bill S. 1082, to amend 
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the 
prescription drug user fee provisions, and for other purposes; which 
was ordered to lie on the table; as follows:

       In title II, strike subtitle D and insert the following:

                   Subtitle D--Conflicts of Interest

     SEC. 241. CONFLICTS OF INTEREST.

       (a) In General.--Subchapter A of chapter VII of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is 
     amended by inserting at the end the following:

     ``SEC. 712. CONFLICTS OF INTEREST.

       ``(a) Definitions.--For purposes of this section:
       ``(1) Advisory committee.--The term `advisory committee' 
     means an advisory committee under the Federal Advisory 
     Committee Act that provides advice or recommendations to the 
     Secretary regarding activities of the Food and Drug 
     Administration.
       ``(2) Financial interest.--The term `financial interest' 
     means a financial interest under section 208(a) of title 18, 
     United States Code.
       ``(b) Appointments to Advisory Committees.--
       ``(1) Recruitment.--
       ``(A) In general.--Given the importance of advisory 
     committees to the review process at the Food and Drug 
     Administration, the Secretary, through the Office of Women's 
     Health, the Office of Orphan Product Development, the Office 
     of Pediatric Therapeutics, and other offices within the Food 
     and Drug Administration with relevant expertise, shall 
     develop and implement strategies on effective outreach to 
     potential members of advisory committees at universities, 
     colleges, other academic research centers, professional and 
     medical societies, and patient and consumer groups. The 
     Secretary shall seek input from professional medical and 
     scientific societies to determine the most effective 
     informational and recruitment activities. The Secretary shall 
     also take into account the advisory committees with the 
     greatest number of vacancies.
       ``(B) Recruitment activities.--The recruitment activities 
     under subparagraph (A) may include--
       ``(i) advertising the process for becoming an advisory 
     committee member at medical and scientific society 
     conferences;
       ``(ii) making widely available, including by using existing 
     electronic communications channels, the contact information 
     for the Food and Drug Administration point of contact 
     regarding advisory committee nominations; and
       ``(iii) developing a method through which an entity 
     receiving funding from the National Institutes of Health, the 
     Agency for Healthcare Research and Quality, the Centers for 
     Disease Control and Prevention, or the Veterans Health 
     Administration can identify a person who the Food and Drug 
     Administration can contact regarding the nomination of 
     individuals to serve on advisory committees.
       ``(2) Evaluation and criteria.--When considering a term 
     appointment to an advisory committee, the Secretary shall 
     review the expertise of the individual and the financial 
     disclosure report filed by the individual pursuant to the 
     Ethics in Government Act of 1978 for each individual under 
     consideration for the appointment, so as to reduce the 
     likelihood that an appointed individual will later require a 
     written determination as referred to in section 208(b)(1) of 
     title 18, United States Code, a written certification as 
     referred to in section 208(b)(3) of title 18, United States 
     Code, or a waiver as referred to in subsection (c)(3) of this 
     section for service on the committee at a meeting of the 
     committee.
       ``(3) Participation of guest expert with financial 
     interest.--Notwithstanding any other provision of this 
     section, an individual with a financial interest with respect 
     to any matter considered by an advisory committee may be 
     allowed to participate in a meeting of an advisory committee 
     as a guest expert if the Secretary determines that the 
     individual has particular expertise required for the meeting. 
     An individual participating as a guest expert may provide 
     information and expert opinion, but shall not participate in 
     the discussion or voting by the members of the advisory 
     committee.
       ``(c) Granting and Disclosure of Waivers.--
       ``(1) In general.--Prior to a meeting of an advisory 
     committee regarding a `particular matter' (as that term is 
     used in section 208 of title 18, United States Code), each 
     member of the committee who is a full-time Government 
     employee or special Government employee shall disclose to the 
     Secretary financial interests in accordance with subsection 
     (b) of such section 208.
       ``(2) Financial interest of advisory committee member or 
     family member.--No member of an advisory committee may vote 
     with respect to any matter considered by the advisory 
     committee if such member (or an immediate family member of 
     such member) has a financial interest that could be affected 
     by the advice given to the Secretary with respect to such 
     matter, excluding interests exempted in regulations issued by 
     the Director of the Office of Government Ethics as too remote 
     or inconsequential to affect the integrity of the services of 
     the Government officers or employees to which such 
     regulations apply.

[[Page 11312]]

       ``(3) Waiver.--The Secretary may grant a waiver of the 
     prohibition in paragraph (2) if such waiver is necessary to 
     afford the advisory committee essential expertise.
       ``(4) Limitations.--
       ``(A) One waiver per committee meeting.--Notwithstanding 
     any other provision of this section, with respect to each 
     advisory committee, the Secretary shall not grant more than 1 
     waiver under paragraph (3) per committee meeting.
       ``(B) Scientific work.--The Secretary may not grant a 
     waiver under paragraph (3) for a member of an advisory 
     committee when the member's own scientific work is involved.
       ``(5) Disclosure of waiver.--Notwithstanding section 
     107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), 
     the following shall apply:
       ``(A) 15 or more days in advance.--As soon as practicable, 
     but in no case later than 15 days prior to a meeting of an 
     advisory committee to which a written determination as 
     referred to in section 208(b)(1) of title 18, United States 
     Code, a written certification as referred to in section 
     208(b)(3) of title 18, United States Code, or a waiver as 
     referred to in paragraph (3) applies, the Secretary shall 
     disclose (other than information exempted from disclosure 
     under section 552 of title 5, United States Code, and section 
     552a of title 5, United States Code (popularly known as the 
     Freedom of Information Act and the Privacy Act of 1974, 
     respectively)) on the Internet website of the Food and Drug 
     Administration--
       ``(i) the type, nature, and magnitude of the financial 
     interests of the advisory committee member to which such 
     determination, certification, or waiver applies; and
       ``(ii) the reasons of the Secretary for such determination, 
     certification, or waiver.
       ``(B) Less than 30 days in advance.--In the case of a 
     financial interest that becomes known to the Secretary less 
     than 30 days prior to a meeting of an advisory committee to 
     which a written determination as referred to in section 
     208(b)(1) of title 18, United States Code, a written 
     certification as referred to in section 208(b)(3) of title 
     18, United States Code, or a waiver as referred to in 
     paragraph (3) applies, the Secretary shall disclose (other 
     than information exempted from disclosure under section 552 
     of title 5, United States Code, and section 552a of title 5, 
     United States Code) on the Internet website of the Food and 
     Drug Administration, the information described in clauses (i) 
     and (ii) of subparagraph (A) as soon as practicable after the 
     Secretary makes such determination, certification, or waiver, 
     but in no case later than the date of such meeting.
       ``(d) Public Record.--The Secretary shall ensure that the 
     public record and transcript of each meeting of an advisory 
     committee includes the disclosure required under subsection 
     (c)(5) (other than information exempted from disclosure under 
     section 552 of title 5, United States Code, and section 552a 
     of title 5, United States Code).
       ``(e) Annual Report.--Not later than February 1 of each 
     year, the Secretary shall submit to the Committee on 
     Appropriations and the Committee on Health, Education, Labor, 
     and Pensions of the Senate, and the Committee on 
     Appropriations and the Committee on Energy and Commerce of 
     the House of Representatives a report that describes--
       ``(1) with respect to the fiscal year that ended on 
     September 30 of the previous year, the number of vacancies on 
     each advisory committee, the number of nominees received for 
     each committee, and the number of such nominees willing to 
     serve;
       ``(2) with respect to such year, the aggregate number of 
     disclosures required under subsection (c)(5) for each meeting 
     of each advisory committee and the percentage of individuals 
     to whom such disclosures did not apply who served on such 
     committee for each such meeting;
       ``(3) with respect to such year, the number of times the 
     disclosures required under subsection (c)(5) occurred under 
     subparagraph (B) of such subsection; and
       ``(4) how the Secretary plans to reduce the number of 
     vacancies reported under paragraph (1) during the fiscal year 
     following such year, and mechanisms to encourage the 
     nomination of individuals for service on an advisory 
     committee, including those who are classified by the Food and 
     Drug Administration as academicians or practitioners.
       ``(f) Periodic Review of Guidance.--Not less than once 
     every 5 years, the Secretary shall review guidance of the 
     Food and Drug Administration regarding conflict of interest 
     waiver determinations with respect to advisory committees and 
     update such guidance as necessary.''.
       (b) Conforming Amendment.--Section 505(n) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended 
     by--
       (1) striking paragraph (4); and
       (2) redesignating paragraphs (5), (6), (7), and (8) as 
     paragraphs (4), (5), (6), and (7), respectively.
       (c) Effective Date.--The amendments made by this section 
     shall take effect on October 1, 2007.
                                 ______
                                 
  SA 1035. Mr. BURR submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the end of the bill, insert the following:

     SEC. __. ADDITION TO PRIORITY LIST CONSIDERATIONS.

       Section 409I of the Public Health Service Act (42 U.S.C. 
     284m), as amended by this Act, is further amended--
       (1) by striking subsection (a)(2) and inserting the 
     following:
       ``(2) Consideration of available information.--In 
     developing and prioritizing the list under paragraph (1), the 
     Secretary--
       ``(A) shall consider--
       ``(i) therapeutic gaps in pediatrics that may include 
     developmental pharmacology, pharmacogenetic determinants of 
     drug response, metabolism of drugs and biologics in children, 
     and pediatric clinical trials;
       ``(ii) particular pediatric diseases, disorders or 
     conditions where more complete knowledge and testing of 
     therapeutics, including drugs and biologics, may be 
     beneficial in pediatric populations; and
       ``(iii) the adequacy of necessary infrastructure to conduct 
     pediatric pharmacological research, including research 
     networks and trained pediatric investigators; and
       ``(B) may consider the availability of qualified 
     countermeasures (as defined in section 319F-1) and qualified 
     pandemic or epidemic products (as defined in section 319F-3) 
     to address the needs of pediatric populations, in 
     consultation with the Assistant Secretary for Preparedness 
     and Response.''; and
       (2) in subsection (b), by striking ``subsection (a)'' and 
     inserting ``paragraphs (1) and (2)(A) of subsection (a)''.

                                 ______
                                 
  SA 1036. Mr. CORKER submitted an amendment intended to be proposed to 
amendment SA 990 submitted by Mr. Dorgan (for himself, Ms. Snowe, Mr. 
Grassley, Mr. McCain, Ms. Stabenow, Mr. Nelson of Florida, Mr. Pryor, 
Mr. Sanders, Mr. Whitehouse, and Mrs. McCaskill) to the bill S. 1082, 
to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and 
amend the prescription drug user fee provisions, and for other 
purposes; which was ordered to lie on the table; as follows:

       On page 88 of the amendment, strike lines 5 through 7 and 
     insert the following:
       ``(B) the packaging, repackaging, labeling, relabeling, or 
     distribution of a prescription drug.
       ``(o) Prohibition on Commingling.--
       ``(1) In general.--A registered importer shall not 
     commingle a prescription drug imported into the United States 
     under this section with another prescription drug unless such 
     other prescription drug is imported from a permitted country.
       ``(2) Label.--A registered importer (including an Internet 
     pharmacy) that dispenses a prescription drug imported from a 
     permitted country shall affix on each dispensed container of 
     the prescription drug the label required under paragraph (3), 
     unless such a label is already affixed to the container.
       ``(3) Requirements.--Each prescription drug imported under 
     this section shall be in a container that bears a label 
     stating, in prominent and conspicuous type--
       ``(A) the lot number of the prescription drug;
       ``(B) the name, address, and phone number of the exporter 
     of the drug, regardless of whether the exporter is 
     registered;
       ``(C) the following statement: `This drug has been imported 
     from ______.' with the name of the permitted country from 
     which the prescription drug has imported in the blank space;
       ``(D) a unique identifier code provided by the Secretary 
     that modifies the national drug code of the prescription drug 
     to indicate that the drug has been imported;
       ``(E) a statement that discloses the originating country of 
     the drug; and
       ``(F) that the container complies with any other applicable 
     requirement of this Act.''.

                                 ______
                                 
  SA 1037. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place in the amendment, insert the 
     following:

     SEC. __. REQUIRED TESTING OF DRUGS.

       Notwithstanding any other provision of this title (and the 
     amendment made by this title) a prescription drug may only be 
     imported by a pharmacist, wholesaler, or individual under 
     this title (or amendments) if the importer of such drug 
     complies with subsections (d)(1) and (e) of section 804 of 
     such Act (21 U.S.C. 384(d)(1) and (e)), as in effect on the 
     day before the date of enactment of this Act.
                                 ______
                                 
  SA 1038. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for

[[Page 11313]]

other purposes; which was ordered to lie on the table; as follows:

       At the appropriate place in the amendment, insert the 
     following:

     SEC. __. REQUIRED FDA APPROVAL OF DRUGS.

       Notwithstanding any other provision of this title (and the 
     amendment made by this title) a prescription drug may only be 
     imported by a pharmacist, wholesaler, or individual under 
     this title (or amendments) if--
       (1) such drug complies with section 505 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355)(including with 
     respect to being safe and effective for the intended use of 
     the prescription drug) and with sections 501 and 502 of such 
     Act (21 U.S.C. 351 and 352);
       (2) the importer of such drug complies with subsections 
     (d)(1) and (e) of section 804 of such Act (21 U.S.C. 
     384(d)(1) and (e)), as in effect on the day before the date 
     of enactment of this Act; and
       (3) the drug or importer of such drug complies with any 
     additional requirements determined by the Secretary of Health 
     and Human Services to be appropriate as a safeguard to 
     protect the public health or as a means to facilitate the 
     importation of prescription drugs.
                                 ______
                                 
  SA 1039. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end of subtitle E of title II, insert the following:

     SEC. 2_. AUTHORITY OF THE OFFICE OF SURVEILLANCE AND 
                   EPIDEMIOLOGY.

       With respect to all actions of the Food and Drug 
     Administration related to postmarketing drug safety, 
     including labeling changes, postapproval studies, and 
     restrictions on distribution or use of drugs with serious 
     risks, the Office of Surveillance and Epidemiology (or 
     successor office) of such Administration and the Office of 
     New Drugs (or successor office) of such Administration shall 
     make decisions jointly. In the event of a disagreement with 
     respect to an action related to postmarketing drug safety, 
     including labeling changes, postapproval studies, and 
     restrictions on distribution or use of drugs with serious 
     risks, between such 2 offices, the Commissioner of Food and 
     Drugs shall make the decision with respect to such action.
                                 ______
                                 
  SA 1040. Mrs. CLINTON (for herself and Mr. Lautenberg) submitted an 
amendment intended to be proposed by her to the bill S. 1082, to amend 
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the 
prescription drug user fee provisions, and for other purposes; which 
was ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

     SEC. __. JOINT TASK FORCE WITH THE FOOD AND DRUG 
                   ADMINISTRATION AND THE DEPARTMENT OF 
                   AGRICULTURE.

       (a) In General.--Not later than 180 days after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services, the Commissioner of Food and Drugs, and the 
     Secretary of Agriculture shall establish a joint task force 
     concerning foodborne illnesses.
       (b) Chairperson.--The Secretary of Health and Human 
     Services shall serve as the chairperson of the joint task 
     force established under subsection (a).
       (c) Duties.--The joint task force established under 
     subsection (a) shall--
       (1) develop recommendations on how to effectively address 
     the problem of foodborne illness in the United States;
       (2) submit to Congress recommendation for changes in the 
     law to address the sources of food contamination before 
     hazards enter the food supply, such as mandatory recall 
     authority, trace back procedures, and modification to farm 
     regulations; and
       (3) identify measures to be taken at the Federal agency 
     level to effectively improve internal and external 
     communication and information sharing with respect to 
     addressing the problem of foodborne illness.
       (d) Participation and Input of Others.--The joint task 
     force established under subsection (a) shall establish 
     mechanisms to allow relevant stakeholder, including farmers, 
     the food industry, consumer groups, and relevant State 
     agencies, to participate in task force activities and to 
     provide the task force with input on food safety policy.
                                 ______
                                 
  SA 1041. Mr. OBAMA submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. IMPROVING GENETIC TEST SAFETY AND QUALITY.

       Not later than 30 days after the date of enactment of this 
     Act, the Secretary shall enter into a contract with the 
     Institute of Medicine to conduct a study and prepare a report 
     that includes recommendations to improve Federal oversight 
     and regulation of genetic tests. Such study shall take into 
     consideration relevant reports by the Secretary's Advisory 
     Committee on Genetic Testing and other groups and shall be 
     completed not later than 1 year after the date on which the 
     Secretary entered into such contract.
                                 ______
                                 
  SA 1042. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. LIABILITY OF HEALTHCARE PROVIDERS.

       A healthcare provider who prescribes, or who dispenses 
     pursuant to a prescription, a drug, biologic product, or 
     medical device approved, licensed, or cleared by the Food and 
     Drug Administration shall not be named as a party to a 
     product liability lawsuit involving such drug, biological 
     product, or medical device and shall not be liable to a 
     claimant in a class action lawsuit against the manufacturer, 
     distributor, or seller of such drug, biological product, or 
     medical device.
                                 ______
                                 
  SA 1043. Mr. REED (for himself and Mr. Dodd) submitted an amendment 
intended to be proposed to amendment SA 1035 submitted by Mr. Burr and 
intended to be proposed to the bill S. 1082, to amend the Federal Food, 
Drug, and Cosmetic Act to reauthorize and amend the prescription drug 
user fee provisions, and for other purposes; which was ordered to lie 
on the table; as follows:

       In lieu of the matter proposed to be inserted, insert the 
     following:
       ( ) Addition to Priority List Considerations.--
       (1) In general.--Section 409I of the Public Health Service 
     Act (42 U.S.C. 284m), as amended by this Act, is amended--
       (A) by striking subsection (a)(2) and inserting the 
     following:
       ``(2) Consideration of available information.--In 
     developing and prioritizing the list under paragraph (1), the 
     Secretary--
       ``(A) shall consider--
       ``(i) therapeutic gaps in pediatrics that may include 
     developmental pharmacology, pharmacogenetic determinants of 
     drug response, metabolism of drugs and biologics in children, 
     and pediatric clinical trials;
       ``(ii) particular pediatric diseases, disorders or 
     conditions where more complete knowledge and testing of 
     therapeutics, including drugs and biologics, may be 
     beneficial in pediatric populations; and
       ``(iii) the adequacy of necessary infrastructure to conduct 
     pediatric pharmacological research, including research 
     networks and trained pediatric investigators; and
       ``(B) may consider the availability of qualified 
     countermeasures (as defined in section 319F-1) and qualified 
     pandemic or epidemic products (as defined in section 319F-3) 
     to address the needs of pediatric populations, in 
     consultation with the Assistant Secretary for Preparedness 
     and Response.''; and
       (B) in subsection (b), by striking ``subsection (a)'' and 
     inserting ``paragraphs (1) and (2)(A) of subsection (a)''.
       (2) Biomedical advanced research and development 
     authority.--Section 319L(c)(6) of the Public Health Service 
     Act (42 U.S.C. 247d-e(c)(6)) is amended by striking ``may 
     give priority'' and inserting ``shall give priority''.
                                 ______
                                 
  SA 1044. Mr. KOHL submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. PROHIBITION ON IMPORTATION FROM A FOREIGN FOOD 
                   FACILITY THAT DENIES ACCESS TO FOOD INSPECTORS.

       Notwithstanding any other provision of law, no food product 
     may be imported into the United States that is the product of 
     a foreign facility registered under section 415 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) that 
     refuses to permit United States inspectors, upon request, to 
     inspect such facility or that unduly delays access to United 
     States inspectors.

[[Page 11314]]



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