121 STAT. 960
PUBLIC LAW 110–85—SEPT. 27, 2007 ‘‘(E) CONFIDENTIAL INFORMATION.—This paragraph does not authorize the disclosure of any trade secret, confidential commercial or financial information, or other matter listed in section 552(b) of title 5, United States Code.’’.
SEC. 917. RISK COMMUNICATION.
Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.), as amended by section 603, is amended by adding at the end the following: 21 USC 360bbb–6. Establishment.
‘‘SEC. 567. RISK COMMUNICATION.
21 USC 355.
SEC. 918. REFERRAL TO ADVISORY COMMITTEE.
‘‘(a) ADVISORY COMMITTEE ON RISK COMMUNICATION.— ‘‘(1) IN GENERAL.—The Secretary shall establish an advisory committee to be known as the ‘Advisory Committee on Risk Communication’ (referred to in this section as the ‘Committee’). ‘‘(2) DUTIES OF COMMITTEE.—The Committee shall advise the Commissioner on methods to effectively communicate risks associated with the products regulated by the Food and Drug Administration. ‘‘(3) MEMBERS.—The Secretary shall ensure that the Committee is composed of experts on risk communication, experts on the risks described in subsection (b), and representatives of patient, consumer, and health professional organizations. ‘‘(4) PERMANENCE OF COMMITTEE.—Section 14 of the Federal Advisory Committee Act shall not apply to the Committee established under this subsection. ‘‘(b) PARTNERSHIPS FOR RISK COMMUNICATION.— ‘‘(1) IN GENERAL.—The Secretary shall partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted systems for communication to health care providers about emerging postmarket drug risks. ‘‘(2) PARTNERSHIPS.—The systems developed under paragraph (1) shall— ‘‘(A) account for the diversity among physicians in terms of practice, willingness to adopt technology, and medical specialty; and ‘‘(B) include the use of existing communication channels, including electronic communications, in place at the Food and Drug Administration.’’.
dkrause on GSDDPC44 with PUBLAW
Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended by section 915, is further amended by adding at the end the following: ‘‘(s) REFERRAL TO ADVISORY COMMITTEE.—Prior to the approval of a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or section 351 of the Public Health Service Act, the Secretary shall— ‘‘(1) refer such drug to a Food and Drug Administration advisory committee for review at a meeting of such advisory committee; or ‘‘(2) if the Secretary does not refer such a drug to a Food and Drug Administration advisory committee prior to the approval of the drug, provide in the action letter on the application for the drug a summary of the reasons why the Secretary
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