What is the official ID of this bill?
The official print number for this legislation is S 1906.
Faster Drug Access for Life-Threatening Illnesses: Provisional Approval Pathway.
This Act establishes a new, accelerated pathway for the provisional approval of drugs treating serious or life-threatening conditions. This allows patients quicker access to promising therapies before they complete the full FDA approval process. Patients must provide informed consent acknowledging the risks and are required to participate in observational registries to track their health data.
Key points
Drugs for life-threatening diseases can be evaluated for provisional approval within 90 days based on early evidence of safety and efficacy.
Health insurers and Federal programs cannot deny coverage for these drugs solely because they are provisionally approved or considered experimental.
Patients must participate in mandatory registries to monitor their data and sign informed consent acknowledging the reduced testing and associated risks.
Drug manufacturers receive limited legal liability protection against claims of unsafety or ineffectiveness, except in cases of gross negligence or willful misconduct.
Status:
Expired
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