Faster Drug Access for Rare Diseases: Conditional Approval and Mandated Coverage.
This law establishes a new, accelerated conditional approval pathway for drugs treating rare, progressive, and serious diseases with high unmet medical needs. Citizens gain quicker access to promising treatments, but must acknowledge that these drugs have not completed the full FDA approval process. Crucially, both private insurers and federal health programs are mandated to cover these conditionally approved drugs without imposing any cost-sharing requirements on patients.
Key points
A conditional approval pathway is created for rare and terminal disease drugs based on preliminary safety and effectiveness evidence (Phase 1 and 2 data).
Patients must provide informed consent and enroll in an observational registry to monitor the drug's long-term effects and safety.
Health insurers (private and federal) must fully cover the cost of conditionally approved drugs, eliminating patient co-pays or deductibles.
Legal liability for manufacturers and prescribing healthcare providers is limited, except in cases of intentional wrongdoing.
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