Passive Adverse Event Approach Is Key Facet Of US FDA's Right-To-Try Rule

 
• By Sarah Karlin-Smith

Sponsors will have little obligation to conduct due diligence of adverse events experienced with right-to-try drug use under a proposed FDA rule, leading critics to once again raise safety concerns with the pathway for accessing experimental medicines. The agency will not help patients or companies determine whether drugs qualify for right-to-try.

rules and regulations marked on rubber stamp
FDA outlines annual reporting requirements for right-to-try in new proposed rule • Source: Shutterstock

Sponsors will not have to proactively monitor serious adverse events of investigational drugs provided under the 2018 “Right-to-Try” law, according to a proposed rule from the US Food and Drug Administration on the annual reporting requirements.

The FDA’s definition of “known serious adverse events” in the rule is renewing old safety concerns about the controversial law that gives patients and doctors a way to request access to experimental treatments without going through the agency’s expanded access program

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