121 STAT. 930
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Deadline.
VerDate Aug 31 2005
13:52 Jan 23, 2009
PUBLIC LAW 110–85—SEPT. 27, 2007
‘‘(f) PROVIDING SAFE ACCESS FOR PATIENTS TO DRUGS WITH KNOWN SERIOUS RISKS THAT WOULD OTHERWISE BE UNAVAILABLE.— ‘‘(1) ALLOWING SAFE ACCESS TO DRUGS WITH KNOWN SERIOUS RISKS.—The Secretary, in consultation with the offices described in subsection (c)(2), may require that the risk evaluation and mitigation strategy for a drug include such elements as are necessary to assure safe use of the drug, because of its inherent toxicity or potential harmfulness, if the Secretary determines that— ‘‘(A) the drug, which has been shown to be effective, but is associated with a serious adverse drug experience, can be approved only if, or would be withdrawn unless, such elements are required as part of such strategy to mitigate a specific serious risk listed in the labeling of the drug; and ‘‘(B) for a drug initially approved without elements to assure safe use, other elements under subsections (c), (d), and (e) are not sufficient to mitigate such serious risk. ‘‘(2) ASSURING ACCESS AND MINIMIZING BURDEN.—Such elements to assure safe use under paragraph (1) shall— ‘‘(A) be commensurate with the specific serious risk listed in the labeling of the drug; ‘‘(B) within 30 days of the date on which any element under paragraph (1) is imposed, be posted publicly by the Secretary with an explanation of how such elements will mitigate the observed safety risk; ‘‘(C) considering such risk, not be unduly burdensome on patient access to the drug, considering in particular— ‘‘(i) patients with serious or life-threatening diseases or conditions; and ‘‘(ii) patients who have difficulty accessing health care (such as patients in rural or medically underserved areas); and ‘‘(D) to the extent practicable, so as to minimize the burden on the health care delivery system— ‘‘(i) conform with elements to assure safe use for other drugs with similar, serious risks; and ‘‘(ii) be designed to be compatible with established distribution, procurement, and dispensing systems for drugs. ‘‘(3) ELEMENTS TO ASSURE SAFE USE.—The elements to assure safe use under paragraph (1) shall include 1 or more goals to mitigate a specific serious risk listed in the labeling of the drug and, to mitigate such risk, may require that— ‘‘(A) health care providers who prescribe the drug have particular training or experience, or are specially certified (the opportunity to obtain such training or certification with respect to the drug shall be available to any willing provider from a frontier area in a widely available training or certification method (including an on-line course or via mail) as approved by the Secretary at reasonable cost to the provider);
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