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'Right to try' effects might be mixed

'Right to try' effects might be mixed

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On paper, Prop. 303 – or the ‘Right to Try’ -- sounds like a lifeline for people struggling with an illness deemed terminal because no FDA-approved drugs are available.

The measure would attempt to legalize at the state level to grant terminally ill people access by to experimental drugs that have passed the first phase of FDA approval with a goal of prolonging or improving their lives.

But some worry that the lifeline offered by Prop. 303 will instead become a snare, entangling the unwary in a spiral of runaway drug costs for little benefit. Think payday loan industry, but with much more heartache.

And whether doctors in Arizona will agree to jeopardize their federal prescribing privileges by participating in an end run around the FDA is also in question.

Nevertheless, it is easy to see why Prop. 303 has attracted popular support. There is nothing more heartbreaking than seeing a loved one suffering while advance reports of clinical drug trials offer much promise but are still years away from final approval.

Prop. 303 would require a physician to determine a patient has a terminal illness, then agree to help guide the patient through the use of an investigational drug. A state regulatory board cannot penalize a doctor or hospital for using an unapproved drug, nor can a state agency block access to such a drug.

Ideally, the measure would apply only to patients who have exhausted all conventional treatment methods. But how extensive those treatments have to be and how a terminal illness is determined are not defined in the proposition. And the measure might put patients at risk because the first phase of FDA approval, in which a drug is tested on healthy individuals, is far easier than the second phase, which tests for toxicity and efficacy. It’s not until a drug reaches the third phase that it’s tested on those with the disease in question.

The measure, if adopted, may lead to some reforms of the process: It takes, on average, 10-25 years and $1 billion for a drug to go through the FDA’s approval system.

Yet there are still physicians practicing today who remember the Thalidomide birth defects tragedy of the 1960s, which struck Great Britain but was avoided in the U.S. because of stricter drug approval regulations. FDA rules may be cumbersome, but they are dealing with life and death issues.

In the end, it may take years for Prop. 303 to take effect in Arizona – if ever. Most constitutional lawyers see the measure as yet another state thumb in the eye of the federal government, and it is unlikely that FDA lawyers will let such a direct challenge to its licensing authority go legally unchallenged. So Arizona will once again be involved in a long, drawn-out court battle over state vs. federal sovereignty – at least John Stewart of Comedy Central will have plenty of new material.

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