PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 929
dkrause on GSDDPC44 with PUBLAW
‘‘(2) to the extent required by the Secretary, in consultation with the office responsible for reviewing the drug and the office responsible for postapproval safety with respect to the drug, include additional elements described in subsections (e) and (f). ‘‘(d) MINIMAL STRATEGY.—For purposes of subsection (c)(1), the risk evaluation and mitigation strategy for a drug shall require a timetable for submission of assessments of the strategy that— ‘‘(1) includes an assessment, by the date that is 18 months after the strategy is initially approved; ‘‘(2) includes an assessment by the date that is 3 years after the strategy is initially approved; ‘‘(3) includes an assessment in the seventh year after the strategy is so approved; and ‘‘(4) subject to paragraphs (1), (2), and (3)— ‘‘(A) is at a frequency specified in the strategy; ‘‘(B) is increased or reduced in frequency as necessary as provided for in subsection (g)(4)(A); and ‘‘(C) is eliminated after the 3-year period described in paragraph (1) if the Secretary determines that serious risks of the drug have been adequately identified and assessed and are being adequately managed. ‘‘(e) ADDITIONAL POTENTIAL ELEMENTS OF STRATEGY.— ‘‘(1) IN GENERAL.—The Secretary, in consultation with the offices described in subsection (c)(2), may under such subsection require that the risk evaluation and mitigation strategy for a drug include 1 or more of the additional elements described in this subsection if the Secretary makes the determination required with respect to each element involved. ‘‘(2) MEDICATION GUIDE; PATIENT PACKAGE INSERT.—The risk evaluation and mitigation strategy for a drug may require that, as applicable, the responsible person develop for distribution to each patient when the drug is dispensed— ‘‘(A) a Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations (or any successor regulations); and ‘‘(B) a patient package insert, if the Secretary determines that such insert may help mitigate a serious risk of the drug. ‘‘(3) COMMUNICATION PLAN.—The risk evaluation and mitigation strategy for a drug may require that the responsible person conduct a communication plan to health care providers, if, with respect to such drug, the Secretary determines that such plan may support implementation of an element of the strategy (including under this paragraph). Such plan may include— ‘‘(A) sending letters to health care providers; ‘‘(B) disseminating information about the elements of the risk evaluation and mitigation strategy to encourage implementation by health care providers of components that apply to such health care providers, or to explain certain safety protocols (such as medical monitoring by periodic laboratory tests); or ‘‘(C) disseminating information to health care providers through professional societies about any serious risks of the drug and any protocol to assure safe use.
VerDate Aug 31 2005
13:52 Jan 23, 2009