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MARCH 5, 2015

Right-to-Try Laws

EDITOR'S NOTE: An updated brief was published April 9, 2015.

Some states have passed legislation intended to expand access to experimental treatments for patients with serious or life-threatening conditions.

What's the issue?
What's the background?

FEDERAL REGULATION OF EXPANDED ACCESS: For these patients, a second option is to apply to the FDA for access to unapproved therapies under the expanded access program. This program allows patients who meet certain eligibility requirements to receive an experimental therapy for treatment purposes rather than as part of the formal clinical research process.

CRITICISM OF THE EXPANDED ACCESS PROGRAM: Critics of the expanded access program have argued that the application process is unnecessarily burdensome and lengthy, which discourages doctors and manufacturers from applying. By the FDA's own estimate, the current IND application can require about 100 hours to complete, and an IRB review adds an additional layer of paperwork and potential delay. For some, these requirements represent an unacceptable barrier for desperate patients seeking to access potentially life-saving drugs.

What's in the laws?
What's the debate?
What's next?
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