PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 927
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‘‘(A) IN GENERAL.—If the Secretary has approved a covered application (including an application approved before the effective date of this section) and did not when approving the application require a risk evaluation and mitigation strategy under paragraph (1), the Secretary, in consultation with the offices described in paragraph (1), may subsequently require such a strategy for the drug involved (including when acting on a supplemental application seeking approval of a new indication for use of the drug) if the Secretary becomes aware of new safety information and makes a determination that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks of the drug. ‘‘(B) SUBMISSION OF PROPOSED STRATEGY.—Not later than 120 days after the Secretary notifies the holder of an approved covered application that the Secretary has made a determination under subparagraph (A) with respect to the drug involved, or within such other reasonable time as the Secretary requires to protect the public health, the holder shall submit to the Secretary a proposed risk evaluation and mitigation strategy. ‘‘(3) ABBREVIATED NEW DRUG APPLICATIONS.—The applicability of this section to an application under section 505(j) is subject to subsection (i). ‘‘(4) 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). ‘‘(b) DEFINITIONS.—For purposes of this section: ‘‘(1) ADVERSE DRUG EXPERIENCE.—The term ‘adverse drug experience’ means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including— ‘‘(A) an adverse event occurring in the course of the use of the drug in professional practice; ‘‘(B) an adverse event occurring from an overdose of the drug, whether accidental or intentional; ‘‘(C) an adverse event occurring from abuse of the drug; ‘‘(D) an adverse event occurring from withdrawal of the drug; and ‘‘(E) any failure of expected pharmacological action of the drug. ‘‘(2) COVERED APPLICATION.—The term ‘covered application’ means an application referred to in section 505(p)(1)(A). ‘‘(3) NEW SAFETY INFORMATION.—The term ‘new safety information’, with respect to a drug, means information derived from a clinical trial, an adverse event report, a postapproval study (including a study under section 505(o)(3)), or peerreviewed biomedical literature; data derived from the postmarket risk identification and analysis system under section 505(k); or other scientific data deemed appropriate by the Secretary about— ‘‘(A) a serious risk or an unexpected serious risk associated with use of the drug that the Secretary has become aware of (that may be based on a new analysis of existing
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