The Right to Try in Florida

Sharon Roberts AttorneyOver the past year or so, Right-to-Try laws have become increasingly popular throughout the United States. These laws allow patients who are terminally ill to access experimental drugs, biologics and devices that have not yet secured the approvals necessary to be distributed widely. Florida recently approved a Right-to-try law for eligible patients.

 

Currently, the Right To Try is limited to patients afflicted with a terminal disease who have already tried the traditional treatments but are unable to enroll in a clinical trial. Essentially this is the last option for these terminal patients. However, it is important to keep in mind that all medications available to these patients must have successfully completed certain safety testing and be included in the FDA’s continuous approval process by law.

 

State Representative Ray Pilon and State Senator Jeff Brandes jointly sponsored the Florida Right to Try Act. Although this has not been approved on a national level, the cause has gained traction as a movement, with supporters expressing themselves on digital platforms.

However, it is important to keep in mind that Federal preemption laws prevent states from creating workarounds that supposedly supersede all of the regulatory infrastructure enforced by the FDA.

In the incidences of patients utilizing a treatment options through the RTT, both manufacturers and physicians will receive liability protection against claims based in adverse events caused by these non-traditional and unapproved treatment options.

Additionally, manufacturers might have the option to charge for the treatments – which are most likely outside of the coverage offered by health insurance.

Although these specifics have yet to be addressed within the acts themselves, support for this movement is quickly spreading, not just in Florida, but across the nation. The Goldwater Institute and a mother based in Indiana have joined forces to support the Right To Try and created a Change.org petition  that has already collected over 95,000 signatures, perhaps indicating the support to come.