Sec. 3. SENSE OF THE SENATE

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## SEC. 3 SENSE OF THE SENATE It is the sense of the Senate that section 561B of the Federal Food, Drug, and Cosmetic Act, as added by section 2— ####

(1)does not establish a new entitlement or modify an existing entitlement, or otherwise establish a positive right to any party or individual; ####

(2)does not establish any new mandates, directives, or additional regulations; ####

(3)only expands the scope of individual liberty and agency among patients, in limited circumstances; ####

(4)is consistent with, and will act as an alternative pathway alongside, existing expanded access policies of the Food and Drug Administration; ####

(5)will not, and cannot, create a cure or effective therapy where none exists; ####

(6)recognizes that the eligible terminally ill patient population often consists of those patients with the highest risk of mortality, and use of experimental treatments under the criteria and procedure described in such section 561A involves an informed assumption of risk; and ####

(7)establishes national standards and rules by which investigational drugs may be provided to terminally ill patients.