A bill that would allow terminally ill people to obtain experimental drugs appears headed to Governor Brown's desk for the second year in a row. Brown vetoed a similar measure last year, but supporters believe conditions are right for him to sign it this time around.
Brown said he vetoed last year’s "Right-to-Try" measure because he wanted time to see how changes to the FDA’s "Compassionate Use" program streamlined the process of getting experimental drugs to terminal patients.
Nearly a year later, the new bill’s supporters say it's time for California to step in with its own solution, because the modified federal initiative has not reduced the minimum 30-day wait for drugs.
"The process may have to start over if the FDA has even one question," said the bill's author, Assembly Majority Leader Ian Calderon (D-Whittier). "Terminally ill patients can still end up waiting weeks and months" for an approval.
Calderon's measure would allow drug manufacturers to give certain terminally ill people access to drugs not yet approved by the FDA.
To qualify, patients would have to be diagnosed with an "immediately life-threatening condition" that left them with only a matter of months to live, and two doctors would have to recommend they try the experimental drug.
The bill has won approval in the State Senate and Assembly; it faces one last concurrence vote in the Assembly as early as Tuesday.
Brown has not indicated whether he would sign the measure.
The Medical Oncology Association of Southern California, which opposes the bill, is concerned about difficulties in identifying which types of life-threatening conditions would qualify under the measure. It also worries about the potential damage such a law might do to enrollment in adult clinical trials.
The California Nurses Association opposes the measure on the grounds that subjecting patients to "unproven, experimental medicines is not the humane solution promised by some of the proponents of this legislation," according to Bonnie Castillo, the Association's health and safety director.
She called for a system in which the development of life-saving drugs "is not subject to the profiteering of the pharmaceutical industry, to ensure that all new drugs are safe, effective, and affordable."
Calderon's office says "Right-to-Try" legislation is already in place in 31 states.