Accelerating Patient Access to Lifesaving Medicines. Strengthening U.S. Competitiveness.
The FAIR Act (H.R. 7953) offers lifesaving regulatory innovation that aims to save lives and advance American leadership in biotechnology for decades to come.
As a bipartisan initiative, the Fast-tracking Approval for Innovative Rare Disease Therapies (FAIR) Act, H.R. 7953, addresses the challenges that are leaving vulnerable patients waiting for treatments they desperately need. At the same time, it works to level the global playing field in biomedical innovation.
Taking Action for Patients With Rare Diseases
Since the Orphan Drug Act was signed into law in 1983, the U.S. Food and Drug Administration (FDA) has approved hundreds of drugs for rare diseases. Despite this progress, most rare diseases, which affect more than 30 million Americans, still do not have FDA-approved treatments.
For those that do, available therapies are often inadequate and fail to appreciably extend patients’ lives, leaving patients and families in urgent need of innovative new therapies.
This treatment gap proliferates despite the availability of safe drugs and biologics that are already vetted internationally based on proven scientific evidence. At the same time, patients in other countries have access to clinical trials for investigational therapies that are not available in the U.S. Patients with rare diseases in the U.S. should not have to wait longer for lifesaving therapies than their counterparts abroad.
What the FAIR Act Does
The FAIR Act builds on the FDA’s proven work and leadership in rare diseases by creating a structured pathway, with an accelerated 30-day review for certain drugs and biologics that are approved by trusted international regulators including the European Medicines Agency, the UK Medicines and Healthcare products Regulatory Agency, and Health Canada. The FAIR Act also allows clinical trials already authorized by these regulators to be cleared for similar studies in the U.S.
By harmonizing drug reviews and approvals as well as clinical trials between the U.S. and trusted global bodies, while still preserving the FDA’s oversight role, the FAIR Act would reduce unnecessary regulatory delays and accelerate access to innovative therapies for patients and families facing urgent unmet medical needs.
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Advocacy for the FAIR Act (H.R. 7953)
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Send a letter to your Congressional representative, request Congressional co-sponsorship or request trade and patient organization endorsements here
Leveling the Playing Field in Biomedical Research
Historically, American leadership in biotechnology has been a cornerstone of U.S. global competitiveness and national security. Yet increasing regulatory unpredictability and holds are forcing American biotech innovators to launch early-phase clinical trials overseas, draining domestic research and stalling patient access to innovative new therapies or clinical trials studying novel investigational approaches.
This treatment gap proliferates despite the availability of safe drugs and biologics that are already vetted internationally based on proven scientific evidence. At the same time, patients in other countries have access to clinical trials for investigational therapies that are not available in the U.S. Patients with rare diseases in the U.S. should not have to wait longer for lifesaving therapies than their counterparts abroad.
Links to Additional Resources
