25 April 2023
Like so many others, our family has experienced the heartbreak of dealing with a severely disabling disease for which no Food and Drug Administration-approved treatments exist. We were fortunate to live close to a clinical trial site and, after years of waiting, our family member was finally approved for the trial. The drug worked. That was more than 30 years ago.
Tens of thousands of people with the same disease still cannot access this drug because they live too far away from a trial site or have some other complicating factor that keeps them out of the drug trial. AB188 would allow a licensed provider to administer this drug if they felt it could bring their patient significant relief from their suffering.
Our current Right-to-Try laws have proven to be a valuable lifeline for numerous patients fighting life-threatening conditions. Assembly Bill 188, or Right-To-Try 2.0, is an essential piece of legislation that seeks to expand this framework and adapt it to rapidly evolving technological medical advances.
It’s crucial to emphasize that AB188 does not bypass the FDA’s authority. The legislation upholds the agency’s oversight and safeguards while simultaneously granting patients access to potentially life-saving treatments that are still under investigation.
AB188 shines the spotlight on individualized treatments, which have become increasingly relevant in this era of precision medicine. By broadening the scope of the Right-to-Try Act, AB188 paves the way for patients with rare or ultra-rare diseases to benefit from cutting-edge treatments designed specifically for their genetic makeup.
As our understanding of the human genome expands and advanced gene therapies emerge, countless patients could benefit from these personalized approaches. However, the current regulatory landscape may impede access to these potentially life-saving interventions.
Far from undermining the FDA’s authority or compromising patient safety, AB188 builds upon the existing Right-to-Try Act to better accommodate individualized treatments. The bill maintains essential safeguards like informed consent, physician certification, drug sponsor agreement, FDA notification and adverse event reporting.
AB188 can help broaden access to innovative therapies for patients who have exhausted all other options. The Right-to-Try 2.0 legislation represents an opportunity to foster hope and potentially save lives without compromising the FDA’s vital oversight role.
Backing Assembly Bill 188 ensures that patients facing life-threatening or severely disabling diseases can access potentially life-saving, individualized treatments. By extending the existing Right-to-Try Act without overriding the FDA’s authority, AB188 presents a compassionate and responsible approach to addressing the urgent needs of patients with no other options left.
Legislators must recognize the potential of this bill to improve and save lives and work together to make it a reality.
Annette Whittemore is the CEO of the Whittemore Peterson Institute, a nonprofit medical research institute dedicated to the support of those with a spectrum of neuro-immune diseases.
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