Accelerated Approval and DTC Advertising – FDA Proposes a Study to Inform Which Direction to Take

In the Federal Register (FR) pre-publication page (here) today, FDA announced a proposed study to evaluate patient/consumer ability to understand the impact of Direct to Consumer (DTC) advertising for products with accelerated approvals.  These products are typically approved based on a surrogate endpoint (such as a blood test) that has a reasonable likelihood to predict clinical benefit.