121 STAT. 926
PUBLIC LAW 110–85—SEPT. 27, 2007
and sections 314.70 and 601.12 of title 21, Code of Federal Regulations (or any successor regulations). ‘‘(5) NON-DELEGATION.—Determinations by the Secretary under this subsection for a drug shall be made by individuals at or above the level of individuals empowered to approve a drug (such as division directors within the Center for Drug Evaluation and Research). ‘‘(p) RISK EVALUATION AND MITIGATION STRATEGY.— ‘‘(1) IN GENERAL.—A person may not introduce or deliver for introduction into interstate commerce a new drug if— ‘‘(A)(i) the application for such drug is approved under subsection (b) or (j) and is subject to section 503(b); or ‘‘(ii) the application for such drug is approved under section 351 of the Public Health Service Act; and ‘‘(B) a risk evaluation and mitigation strategy is required under section 505–1 with respect to the drug and the person fails to maintain compliance with the requirements of the approved strategy or with other requirements under section 505–1, including requirements regarding assessments of approved strategies. ‘‘(2) CERTAIN POSTMARKET STUDIES.—The failure to conduct a postmarket study under section 506, subpart H of part 314, or subpart E of part 601 of title 21, Code of Federal Regulations (or any successor regulations), is deemed to be a violation of paragraph (1).’’. (b) REQUIREMENTS REGARDING STRATEGIES.—Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505 the following section: 21 USC 355–1.
‘‘SEC. 505–1. RISK EVALUATION AND MITIGATION STRATEGIES.
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‘‘(a) SUBMISSION OF PROPOSED STRATEGY.— ‘‘(1) INITIAL APPROVAL.—If the Secretary, in consultation with the office responsible for reviewing the drug and the office responsible for postapproval safety with respect to the drug, determines that a risk evaluation and mitigation strategy is necessary to ensure that the benefits of the drug outweigh the risks of the drug, and informs the person who submits such application of such determination, then such person shall submit to the Secretary as part of such application a proposed risk evaluation and mitigation strategy. In making such a determination, the Secretary shall consider the following factors: ‘‘(A) The estimated size of the population likely to use the drug involved. ‘‘(B) The seriousness of the disease or condition that is to be treated with the drug. ‘‘(C) The expected benefit of the drug with respect to such disease or condition. ‘‘(D) The expected or actual duration of treatment with the drug. ‘‘(E) The seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug. ‘‘(F) Whether the drug is a new molecular entity. ‘‘(2) POSTAPPROVAL REQUIREMENT.—
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