Industry, patient and investor stakeholders say FDA's new benefit-risk framework could become a powerful aid to communication and discussions with the agency. But so far the agency has no plans to share the documentation created by the scheme with sponsors or the public, except after a product approval and probably in advisory committee meetings.

Thus the framework's most near-term effect will be within FDA, where the new tool will assist the agency with its most difficult decisions - including the resolution of internal disagreements about the balance between benefit and risk.