Data Collection & Right to Try Patients

The federal Right to Try Acts prevent the FDA from using outcome data from Right to Try patients to delay or deny ultimate approval of a treatment. This has led to people to conclude that the FDA will not be given any data about Right to Try patients. This is incorrect.

 

Q: Will the FDA be given data about Right to Try patients?
A: Yes! Drug manufacturers are required to report adverse events to the FDA (and data safety monitoring boards, site investigators, and others) whether they happen in a FDA-sanctioned clinical trial or outside a clinical trial. Right to Try doesn’t change that; adverse events will still be reported to the FDA. All the law says is that this data alone cannot be used to stop a trial, or to delay or deny approval of the treatment. The FDA will still be allowed to have conversations with the manufacturer about the adverse events, request more information, and even recommend changes in trial protocols. Bottom line: Right to Try does not keep data from the FDA—it just says that the FDA must decide whether to approve or reject a treatment based on the clinical trial results and nothing else, just as the Agency would if no patient had accessed a treatment through a Right to Try law.