Senate Passes Federal Right-To-Try

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Article source: Stem Cells Daily

The U.S. Senate just passed a bill that if it becomes law would codify Right-To-Try as a federal law, meaning terminally patients across the U.S. could ask their physicians and drug manufacturers to be given still investigational therapies such as still unproven stem cell therapies in development. The bill’s official name is “The Trickett Wendler Frank Mongiello Jordan McLinn,and Matthew Bellina Right to Try Act of 2017.” Its goal is summarized this way, “To authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.”

It has 7 key bullet points according to 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.

Proponents say it makes good sense and is ethical that such extremely ill patients should be given the right to try a wide range of options including unproven therapies, while opponents say it is too risky and that the FDA’s current compassionate use/expanded access program already works for such patients. It is likely that this bill will become law soon.