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May 8, 2007, 12:00 am ET - Amendment SA 1034 proposed by Senator Brown for Senator Durbin.
May 9, 2007, 12:00 am ET - Considered by Senate.
May 9, 2007, 12:37 pm ET - Durbin Amdt. No. 1034

Full Text of this Amendment

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.
``(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.


(As printed in the Congressional Record for the Senate on May 3, 2007.)