Idaho Lawmakers Mull Whether To Authorize 'Right To Try' Unapproved Medicines | KUOW News and Information

Idaho Lawmakers Mull Whether To Authorize 'Right To Try' Unapproved Medicines

Feb 11, 2016
Originally published on February 12, 2016 1:59 pm

The process for getting a new drug approved in the U.S. takes years. If you’re very sick, it can be incredibly frustrating to learn a potential cure is out there, but may not reach the market in time to save your life.

But new legislation in Idaho is meant to give dying patients hope.

The catchphrase for this is “The Right to Try.” In other words, patients diagnosed with a terminal illness could ask for experimental drugs or devices not yet approved by the Food and Drug Administration. State legislatures in about half of U.S. states - including neighboring Oregon - have established the Right to Try in the past couple years.

Boise physician Dr. James Quinn pitched it to his state representative.

“If you have been diagnosed with a terminal illness, you have no other hope,” Quinn said. “This is a chance where you can say, I’m going to try it. I’m going to do the very best I can with this medication in the hope it will work. And if it doesn’t, at least you can say, ‘I did the very best I can.’”

Quinn was in the audience when the Idaho House Health & Welfare Committee voted to introduce the concept Thursday. The panel posed a few pointed questions about whether this is “a way to go around FDA rules.”

“The compassionate use programs that do exist have a lot of bureaucratic hoops to jump through,” replied the prime sponsor, state Rep. Melissa Wintrow, D-Boise.

“As you hear patients talk about the frustration of trying to save their life and managing those trial programs and compassionate use programs, this is a way, I don’t like to say go around the FDA, but it is a way to try that lifesaving opportunity,” Wintrow said. “When somebody is so desperate and in such dire straits, I think we should get out of the way and let them try something.”

The Arizona-based Goldwater Institute, which describes itself as being dedicated to “limited government,” gets credit for promoting Right to Try around the country. The nonprofit circulated a model law for legislators to consider.

Last summer, the Oregon Legislature unanimously approved a version of Right to Try for terminally ill patients estimated to have less than six months to live. The law took effect on January 1.

The California legislature also passed a Right to Try Act last year, but Governor Jerry Brown vetoed the legislation in October.

“Patients with life threatening conditions should be able to try experimental drugs, and the U.S. Food and Drug Administration’s compassionate use program allows this to happen,” Brown wrote in his veto message. “The proposed changes to this program will streamline access to these drugs. Before authorizing an alternative state pathway, we should give this federal expedited process a chance to work.”

In the states where Right to Try has passed, a terminally ill patient can ask a manufacturer to provide an investigational drug or device that has cleared the basic safety testing required by the FDA. The treating physician would need to give his or her recommendation. If granted access to the experimental treatment, the patient bypasses the potentially years-long wait for clinical trials on efficacy to be completed.

The legislation releases liability from doctors, hospitals and insurers. The patient has the financial responsibility to pay for the experimental drug or device as the act makes it clear that insurers or government programs would not cover such treatment.

“It puts the autonomy in the patient’s hands to save their own life,” Wintrow said.

Independently from Dr. Quinn, Wintrow said a constituent with Lou Gehrig's disease, which attacks cells that control muscles, also asked her to introduce Right to Try in the Idaho Legislature. Wintrow said that man is now too sick to speak at the upcoming public hearing on her measure, but she expects others in dire straits to provide emotional testimony.

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