Faster Drug Access for Serious Diseases: Provisional Approvals and Patient Registries.
This new act aims to accelerate access to drugs for serious diseases, including those related to epidemics, by introducing provisional approvals. Citizens using these drugs will need to provide consent and participate in registries, ensuring safety and efficacy monitoring. The act seeks to facilitate faster treatment in critical situations while maintaining data transparency.
Key points
Drugs for serious diseases, including COVID-19, can be approved faster, potentially within 90 days, and during epidemics, within 3 weeks of partial application submission.
Provisional drug approval lasts 2 years, renewable up to 6 years; full approval is possible if the drug shows a 15% improvement over standard therapies.
Private and federal health insurers cannot deny coverage for provisionally approved drugs, treating them like fully approved medications.
Patients using provisionally approved drugs must give informed consent and participate in registries to monitor their health and side effects.
A Patient Advocate General position will be established within the FDA to assist patients and their families using new drugs.
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