Faster Access to Drugs for Rare and Fatal Diseases: Conditional FDA Approval.
This Act establishes a new conditional approval pathway for drugs treating rare, rapidly progressive, and terminal diseases. This means patients with serious, incurable conditions can gain access to promising therapies sooner, before full FDA approval is granted. Crucially, the law mandates that private and federal health care programs must cover the costs of these conditionally approved drugs, eliminating cost-sharing requirements for patients.
Key points
Conditional Drug Approval: The FDA can grant faster approval for drugs targeting rare, progressive, and terminal diseases based on preliminary evidence of safety and effectiveness (e.g., Phase 1 and 2 data).
Mandatory Insurance Coverage: Private health plans and Federal health care programs (like Medicare/Medicaid) must cover these conditionally approved drugs without imposing any cost-sharing requirements on patients.
Observational Registries: Patients receiving conditionally approved drugs must enroll in an observational registry to collect real-world data on safety, side effects, and outcomes, which is vital for the drug's ongoing evaluation.
Liability Limitation: Drug sponsors, manufacturers, and prescribing healthcare providers are protected from liability under State law, absent intentional wrongdoing.
Time Limit: Conditional approval lasts for 2 years and can be renewed up to a maximum of 8 years, after which the drug must seek full approval or be withdrawn.
Expired
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