FL S1552

Allows licensed physicians to prescribe and eligible facilities to administer experimental treatments—drugs, biologics, devices, or personalized genomic therapies that have completed FDA phase 1 clinical trials but lack full approval—to patients with terminal conditions (death expected within 1 year) or rare life-threatening diseases affecting fewer than 200,000 people in the U.S.

Requires experimental treatments to be administered under an Institutional Review Board-approved platform or master protocol, with eligible patients providing detailed written informed consent covering risks, benefits, cost liability, and authorization to share de-identified health data with a state patient registry.

Directs the Department of Health to establish a patient registry for tracking treatment outcomes, publish an annual public report on aggregate outcomes and safety signals, license experimental treatment centers within 90 days of a completed application, and adopt operational and procedural standards by rule.

Sets reimbursement for experimental treatments at a department-determined discounted rate based on recognized pricing benchmarks (e.g., wholesale acquisition cost), requires manufacturers to offer a temporary price concession, and ties both the discount and concession to registry compliance—with rates expiring upon full FDA approval.

Prohibits licensing boards and state agencies from taking action against physicians solely for recommending experimental treatments, shields compliant manufacturers and providers from private causes of action (except for gross negligence or willful misconduct), and bars public officials from denying patient access to authorized experimental treatments.