Page:United States Statutes at Large Volume 121.djvu/952

 PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 931

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‘‘(B) pharmacies, practitioners, or health care settings that dispense the drug are specially certified (the opportunity to obtain such certification shall be available to any willing provider from a frontier area); ‘‘(C) the drug be dispensed to patients only in certain health care settings, such as hospitals; ‘‘(D) the drug be dispensed to patients with evidence or other documentation of safe-use conditions, such as laboratory test results; ‘‘(E) each patient using the drug be subject to certain monitoring; or ‘‘(F) each patient using the drug be enrolled in a registry. ‘‘(4) IMPLEMENTATION SYSTEM.—The elements to assure safe use under paragraph (1) that are described in subparagraphs (B), (C), and (D) of paragraph (3) may include a system through which the applicant is able to take reasonable steps to— ‘‘(A) monitor and evaluate implementation of such elements by health care providers, pharmacists, and other parties in the health care system who are responsible for implementing such elements; and ‘‘(B) work to improve implementation of such elements by such persons. ‘‘(5) EVALUATION OF ELEMENTS TO ASSURE SAFE USE.—The Secretary, through the Drug Safety and Risk Management Advisory Committee (or successor committee) of the Food and Drug Administration, shall— ‘‘(A) seek input from patients, physicians, pharmacists, and other health care providers about how elements to assure safe use under this subsection for 1 or more drugs may be standardized so as not to be— ‘‘(i) unduly burdensome on patient access to the drug; and ‘‘(ii) to the extent practicable, minimize the burden on the health care delivery system; ‘‘(B) at least annually, evaluate, for 1 or more drugs, the elements to assure safe use of such drug to assess whether the elements— ‘‘(i) assure safe use of the drug; ‘‘(ii) are not unduly burdensome on patient access to the drug; and ‘‘(iii) to the extent practicable, minimize the burden on the health care delivery system; and ‘‘(C) considering such input and evaluations— ‘‘(i) issue or modify agency guidance about how to implement the requirements of this subsection; and ‘‘(ii) modify elements under this subsection for 1 or more drugs as appropriate. ‘‘(6) ADDITIONAL MECHANISMS TO ASSURE ACCESS.—The mechanisms under section 561 to provide for expanded access for patients with serious or life-threatening diseases or conditions may be used to provide access for patients with a serious or life-threatening disease or condition, the treatment of which is not an approved use for the drug, to a drug that is subject to elements to assure safe use under this subsection. The Secretary shall promulgate regulations for how a physician may provide the drug under the mechanisms of section 561.

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