Colorado lawmakers want to make it easier for patients with terminal illnesses to get experimental drugs. They’re proposing “Right to Try” legislation, which would allow patients to access drugs that are still undergoing clinical trials.
Under the legislation, a doctor and a patient would discuss the patient's options and decide together if it makes sense for the patient to try a certain medication. The Food and Drug Administration already has a process that allows patients to take a drug that hasn’t been approved, but some doctors and patients say it takes too long. Ultimately, it would be up to the FDA to decide whether to expedite the process if the legislation passes in Colorado.
State Representative Janek Joshi, a Republican from Colorado Springs, says sometimes terminally ill people or their doctors hear about experimental drugs that could help them. But, Joshi says, they aren't allowed to take part in studies for those drugs because their life expectancies are too short.
“They couldn’t qualify for clinical trials, so they could not access the medications,” Joshi says.
Joshi, a retired doctor, says when he was practicing medicine, he knew of many experimental drugs that could help patients, but he was unable to obtain them for his patients.
Under the legislation, a doctor would not be liable if the drug caused adverse side-effects for a patient.
“We are giving them the immunity [that] they are not responsible because going into this, the patient will realize that this is an experimental drug even though it has been tried on several patients and may have worked,” Joshi says.
The legislation also exempts insurance companies from providing care to a patient who decided to take an experimental drug unless the insurer determined that the care was for the pre-existing condition and not the medication.
Joshi says he’s heard many stories of very sick patients who tried to get approval to take certain drugs, but became too frustrated by the process.
"A lot of patients just give up because they know they will not be able to get it before their time is up,” Joshi says.
Insurance companies have expressed concerns that gray areas remain in the bill, but they are currently neutral, since adjustments are still being made to the bill.
A spokesperson for the FDA says at this time the agency does not have a position on the bill. Several states, including Missourri, Connecticut and Louisiana, are considering similar legislation.
