“RIGHT TO TRY” ACT: Individual Patient Treatments

Posted on March 8, 2024 by Dr. David Edward Marcinko MBA MEd CMP™

TO FIX THE FDA APPROVAL’S FLAW

By Staff Reporters

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DEFINITION: Right-to-try laws are United States state laws and a federal law that were created with the intent of allowing terminally ill patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but have not been approved by the Food and Drug Administration (FDA).

Right to Try 2.0 laws could help fix FDA’s approval process; Right to Try for Individualized Treatments. 

This law would allow patients suffering from rare and genetic diseases to try personalized treatments not yet approved by the FDA, as long as they have the support of their physician and have exhausted other treatment options. This policy would have an outsized impact on patients with rare diseases. Although rare diseases have small patient pools by definition, collectively, about 30 million Americans are estimated to have a rare disease.

What’s more, 80% of these rare diseases are genetic in nature, and 95% have no FDA-approved treatment.

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