LINCOLN (AP) — A new Nebraska law will give terminally ill patients the opportunity to attempt treatments that have not yet received approval from the federal Food and Drug Administration, but some doubt the change will make much difference.
The bill’s sponsor, Sen. Robert Hilkemann, a retired podiatrist from Omaha, said the so-called “right-to-try” legislation eases the process for terminally ill patients to access unapproved treatments and drugs in the clinical trial stages of FDA approval. The law will go into effect in July.
Supporters tout the law as a way to bypass bureaucratic FDA reviews that can take up to a decade before drugs arrive on the market. The federal government already has a program called the Compassionate Use Act that last year let about 1,500 people seek expanded access to unapproved medicine, but the new law will let Nebraska join 39 other states in making the process quicker and easier.
Hilkemann said the FDA can take months to process requests, lessening the chance terminally ill patients could benefit from treatments.
Sen. Mark Kolterman, of Seward, supported the change, noting the opportunity to try a new drug could have helped his wife of 46 years, Suzanne Geis. She died from pancreatic cancer last year.
“When you’re in a situation with a terminal illness, you’d do everything you can to try to help them,” he said.
However, some physicians remain skeptical that much will change in Nebraska.
Lincoln Dr. Leslie Spry, a member of the Nebraska Medical Association’s committee on legislation, acknowledged existing federal rules are cumbersome, as they require doctors to do extensive, specialized research and fill out lengthy requests.
The new state law decreases reporting requirements, but Spry said, “for me to advise a patient about these treatments, I would have to do a lot of work to be comfortable with what the drug is and does and how it could affect my patient.”
To receive unproven treatment, patients often must join clinical trials, and that can be difficult regardless of what state and federal laws allow because the studies are highly selective. Kolterman said his wife didn’t qualify for trials because her cancer was so advanced.
And even for those who can participate, Spry notes that only about one in 10 drugs or treatments will ever be approved.
Cost is another issue, as right-to-try laws give companies the option to charge for treatment and insurance companies aren’t obligated to cover such treatment. Some pharmaceutical companies provide free treatment to qualified patients.
Since right-to-try legislation began gaining traction in other states three years ago, Hilkemann said the FDA has tried to make the Compassionate Use process more efficient. If a doctor files for emergency use, the process can be expedited.
That was the case in 2014, when the University of Nebraska Medical Center called for emergency access to then-unapproved medication to treat a doctor with Ebola.
Without an emergency, Hilkemann said the FDA’s Compassionate Use process could still take up to six months.
“With right-to-try, it’s about individual doctors,” Hilkemann said. “And if a doctor talks to the drug manufacturer, they can potentially get the process going in a matter of days.”
Hilkemann initially introduced his measure two years ago, and if approved it would have made Nebraska among the first states to adopt the policy. However, the 2016 legislative session ran out of time and his bill was held up last year by unrelated politics. The measure passed 35-13 this year.
While results of experimental drugs are unknown, Kolterman said families should be able to try everything to save someone they love.
“It’s something you can’t understand until you’re living it,” he said. “We would’ve tried anything.”