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What Does ‘Right to Try’ Act Mean for Providers and Patients?

by Eugene K. Pettis on Categories: right to try act

What Does ‘Right to Try’ Act Mean for Providers and Patients?

Under the Right to Try Act signed into law this May, patients with life-threatening conditions can directly ask drug manufacturers for experimental treatments that have not yet been completely reviewed and approved by the Federal Drug Administration (FDA). The goal of the federal law – and the 38 state laws that preceded its passage – is to provide a possible life-saving option when traditional treatments have failed.

In that regard, the law echoes the FDA’s “compassionate use” program, which gave expedited approval to patients seeking medications that were still under study. Now, the patient and physician can bypass the FDA and go straight to the manufacturer of the drug or medical device.

Under the new law, an experimental drug, biological product or device must have successfully completed a phase 1 clinical investigation, the first of a multi-step FDA approval process. It must remain under investigation in a clinical trial approved by the FDA and not be licensed or cleared for commercial distribution.

The law also provides liability protection to a physician prescribing the drug, as well as the manufacturer, distributor, dispenser or user. So, whatever the outcome, it’s unlikely to result in a medical malpractice lawsuit.

However, the law does not require a drug manufacturer to make an experimental medication available to a patient or provider. Nor does it mandate affordable pricing for new treatments.

In some cases, a manufacturer might choose to withhold a new treatment because of the potential for negative outcomes. Giving an early-stage drug to patients who die would result in negative statistics and perhaps delay eventual FDA approval or success in the commercial market.

On the other hand, a manufacturer might try to publicize an unproven drug or device to capitalize on the desperation of patients hoping for a cure.        

Along with these concerns, there are other issues for patients and providers to consider before embarking on a medical journey with an unknown destination.

First of all, phase 1 clinical trials are designed primarily to check for adverse reactions, and involve only a small sample of patients. About 70 percent of those experimental treatments move into phase II trials, which may test different dosages or formulations of the drugs . If successful, those treatments then progress to large-scale phase III and phase IV trials that deliver far more accurate assessments of safety and efficacy or effectiveness.

Because only about 5 percent of experimental treatments that pass phase I trials ever make it to market, the odds are against an unproven drug being effective for a patient’s condition. That doesn’t mean an experimental drug shouldn’t be tried when all else fails, but both the patient and provider should have realistic expectations about the results.

Finally, there is usually a small subset of patients who beat the odds for even the most challenging medical conditions. Trying an experimental treatment could reduce even a 5 to 10 percent chance of survival. Therefore, both patients and providers should carefully consider their options before making a decision based on the new “right to try” law.

Eugene K. Pettis is a founding partner at Haliczer Pettis & Schwamm whose trial practice includes medical malpractice, personal injury, commercial litigation and professional liability matters.

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