The Senate Health and Welfare Committee approved major legislation this
week that would allow a terminally ill patient that has an advanced
illness to try an experimental drug that has completed Phase I of
clinical trials but is still pending approval by the Federal Drug
Administration (FDA). Senate Bill 811
would apply to terminally ill patients who have tried all other
treatment options that are currently available as long as their
physician has recommended it and the diagnosis and prognosis has been
confirmed by a second physician.
Drugs and medical devices undergo three phases of clinical trials before
they go to the FDA for review. The process can take more than a
decade. Other than clinical trials, which are difficult to qualify for,
the FDA has provisions for patients who want to access experimental
drugs under its compassionate use program, but that process is also
lengthy and time-consuming.
The bill also releases the physician and treatment facility from liability for using the drug.
The proposal now heads to the Senate floor for final approval.
The above is reposted from Senator Jack Johnson's newsletter. Rod
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