FAIR Act Coalition
Improving Rare Disease Access & Strengthening Innovation
Background
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The biopharma industry is routinely opting to launch clinical trials outside of the US to avoid what can be a lengthy review and approval process at the FDA.
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The result is a growing imbalance in the number of clinical trials between the US and the rest of the world. Already, China is dramatically ramping-up the number of registered clinical trials and has stated its intention to dominate the race for global biopharmaceutical innovation.
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Chinese companies are leveraging publicly available patent and press release data from US biopharma companies to create copycat or fast-follow drugs. As a result, China is poised to leapfrog the US in medical innovation.
The Shifting Landscape for Rare Disease Trials & Approved Products
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There have been several historical examples of US drug approvals lagging behind trusted nations and regulatory authorities, resulting in delays in patient access to innovative medicines, including life-threatening diseases with inadequate therapeutic options.
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Companies are now routinely launching trials in markets such as the European Union and Australia, some of these trials are never available to US patients
A Growing Access Gap for Rare Disease Patients
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When clinical trials move abroad, US patients lose out on the opportunity to participate in cutting-edge biomedical research and the potential health benefits it can bring.
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It sets the stage for delays in access to innovative medicines as US approvals could occur long after approvals in other nations. Furthermore, we are seeing clinical research jobs move abroad, eroding the US’s historic leadership in biomedical innovation.
The FAIR Act
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The FAIR Act directly confronts threats to U.S. leadership in biomedical innovation and delayed patient access to critical new therapies. By creating an accelerated 30-day review for products and clinical trials already approved by trusted international regulators, the FAIR Act aims to bring cutting-edge research and innovative medicines to American patients faster, while simultaneously bolstering the U.S. biopharmaceutical sector and retaining clinical research jobs.
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The FAIR Act would require the FDA to conduct an accelerated review within 30 days of any products or clinical trials (for drugs or biologics) for life-threatening diseases that are approved by trusted regulatory authorities but not yet approved in the US.
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Learn More About the FAIR Act
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Legislative Text
TAKE ACTION TODAY: Advocacy for the FAIR Act
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For Organizations (e.g. patient organizations, trade organizations): click here to ENDORSE the FAIR Act
For More Information: Email partnering@avivastrategies.com
