BIO appreciates FDA’s efforts to further clarify labeling practices for products approved under the Accelerated Approval pathway. BIO strongly supported provisions under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) that encouraged FDA to “implement more broadly effective processes for the expedited development and review of innovative new medicines intended to address unmet medical needs for serious or life-threatening diseases or conditions, including those for rare diseases or conditions, using a broad range of surrogate or clinical endpoints and modern scientific tools earlier in the drug development cycle when appropriate.” (§901)
To that end, we believe that it is appropriate for the Agency to assist review divisions in embracing the use of Accelerated Approval more expansively, and foster more consistent approaches to how these products will be labeled across different indications. If the Agency has greater certainty that the product label is appropriately communicating the full context of anticipated benefits, potential risks, and residual scientific uncertainty to healthcare professionals, then medical reviewers should have greater confidence in granting Accelerated Approvals on a more routine basis for serious and life-threatening indications across a variety of serious conditions. However, that goal must also be carefully balanced against potential unintended consequences that may hinder the utilization of important new medicines to treat serious diseases and address key public health priorities.