Senate Bill 616 Summary

• Establishes the "Right to Try Act" allowing terminally ill patients to request access to investigational drugs, biological products, or devices that have completed FDA Phase 1 clinical trials but are not yet approved for general use.

• Requires eligible patients to have a terminal illness attested by their treating physician, have considered all FDA-approved treatment options, receive physician recommendation, and provide written informed consent that includes disclosure of potential risks including death.

• Permits manufacturers to provide investigational treatments to eligible patients without compensation or to require patients to pay manufacturing costs, without mandating manufacturer participation.

• Prohibits the State Board of Medical Licensure and Supervision, Oklahoma Board of Nursing, and State Board of Osteopathic Examiners from revoking, suspending, or taking action against health care providers' licenses based solely on recommendations for investigational treatments.

• Protects manufacturers and care providers from private lawsuits for harm resulting from investigational treatments when acting in good faith with reasonable care, and clarifies that health plans and government agencies are not required to cover these treatments; effective November 1, 2015.