OKLAHOMA CITY – According to the Pew Charitable Trust, some critics of the years-long federal Food and Drug Administration drug approval process, with its requirement for multiple clinical trials, contend that it is much longer than it should be, thereby keeping some promising drugs from those who might benefit.
Withholding drugs from the most gravely ill has fueled several states to pass so-called “right-to-try” legislation that would make these drugs available, without FDA approval, to terminally ill patients with no other option.
“The Goldwater Institute, a conservative non-profit that defends states’ rights, created model legislation in Colorado, and I have used that model to draft my legislation,” House Bill 1074, said state Rep. Richard Morrissette (D-Oklahoma City).
“I am especially concerned for our children diagnosed with terminal illness, who for want of a drug may be stuck in some trial for a decade, when a second chance at life might be possible,” the Oklahoma City Democrat said. “This is a pro-life issue and it seems we have all waited long enough for the process of clinical trials to improve without any relief. It is the system that’s terminal.”
Legislation in four states has now passed overwhelmingly with bipartisan support. All of the existing laws and the Morrissette proposal leave the decision to try an unapproved medication to the patient, the doctor and the drug company.
In all participating states, the laws are supposed to open up access to drugs that passed through just the first stage of clinical trials and are part of ongoing trials. It has yet to be determined if ‘right-to-try’ legislation will withstand a legal challenge from the federal government.