Although US Food and Drug Administration officials have been enthusiastic about the prospects of using real-world evidence to support new claims of efficacy, Robert Temple, deputy director for clinical science in the Center for Drug Evaluation and Research (CDER) offered an especially pessimistic assessment of the concept at the FDA panel discussion at the Biopharma Congress this past October. Pink Sheet shares his basis for skepticism and looks deeper at his history of questioning the use of real-world data to demonstrate the effectiveness of a drug and CDER director, Janet Woodcock’s echoing of the sentiment.