The lack of effectiveness would have consequences. When we're looking at the definitions, we're really focusing on the consequence. Regardless of the upstream cause of it, you're looking at something that could have an impact on patient safety or endangering patient safety. Then we have the powers to do something about it, regardless of the actual cause. That lack of effectiveness, or for a drug to work, would get captured in the definition.
On June 12th, 2014. See this statement in context.