FDA Widens Scope In Considering Evidence For Off-Label Use

After much wrangling, the US agency finally clarified its position on what evidence can determine "intended use" of a product – and industry is not happy.

Metal fork about to be inserted into an open electrical outlet socket.

The US Food and Drug Administration in a 2 August final rule broadened the benchmarks for what can be considered evidence for intended use of a device or drug, going against an industry that wanted a more narrow approach focused on a firm’s promotional claims.

The rule puts a cap on five years of drama on the issue of intended use that began in 2015...