Page:United States Statutes at Large Volume 121.djvu/957

 121 STAT. 936

PUBLIC LAW 110–85—SEPT. 27, 2007

dkrause on GSDDPC44 with PUBLAW

receiving the recommendation of the Drug Safety Oversight Board. ‘‘(H) INACTION.—An approved risk evaluation and mitigation strategy shall remain in effect until the Secretary acts, if the Secretary fails to act as provided for under subparagraph (G). ‘‘(I) EFFECT ON ACTION DEADLINE.—With respect to a proposal or assessment referred to in paragraph (1), the Secretary shall be considered to have met the action deadline for the action letter on the application if the responsible person requests the dispute resolution process described in this paragraph and if the Secretary— ‘‘(i) has initiated the discussions described under paragraph (2) not less than 60 days before such action deadline; and ‘‘(ii) has complied with the timing requirements of scheduling review by the Drug Safety Oversight Board, providing a written recommendation, and issuing an action letter under subparagraphs (B), (F), and (G), respectively. ‘‘(J) DISQUALIFICATION.—No individual who is an employee of the Food and Drug Administration and who reviews a drug or who participated in an administrative appeal under subparagraph (C)(i) with respect to such drug may serve on the Drug Safety Oversight Board at a meeting under subparagraph (D) to review a dispute about the risk evaluation and mitigation strategy for such drug. ‘‘(K) ADDITIONAL EXPERTISE.—The Drug Safety Oversight Board may add members with relevant expertise from the Food and Drug Administration, including the Office of Pediatrics, the Office of Women’s Health, or the Office of Rare Diseases, or from other Federal public health or health care agencies, for a meeting under subparagraph (D) of the Drug Safety Oversight Board. ‘‘(6) USE OF ADVISORY COMMITTEES.—The Secretary may convene a meeting of 1 or more advisory committees of the Food and Drug Administration to— ‘‘(A) review a concern about the safety of a drug or class of drugs, including before an assessment of the risk evaluation and mitigation strategy or strategies of such drug or drugs is required to be submitted under any of subparagraphs (B) through (D) of subsection (g)(2); ‘‘(B) review the risk evaluation and mitigation strategy or strategies of a drug or group of drugs; or ‘‘(C) review a dispute under paragraph (4) or (5). ‘‘(7) PROCESS FOR ADDRESSING DRUG CLASS EFFECTS.— ‘‘(A) IN GENERAL.—When a concern about a serious risk of a drug may be related to the pharmacological class of the drug, the Secretary, in consultation with the offices described in subsection (c)(2), may defer assessments of the approved risk evaluation and mitigation strategies for such drugs until the Secretary has convened 1 or more public meetings to consider possible responses to such concern. ‘‘(B) NOTICE.—If the Secretary defers an assessment under subparagraph (A), the Secretary shall—

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