Scott Gottlieb, Mark McClellan warn of the major challenges created by planned reorganization of FDA

Scott Gottlieb

Mark B. McClellan

Two former FDA commissioners—Scott Gottlieb and Mark B. McClellan­—warned that the Trump administration’s proposal to restructure FDA by consolidating the different product centers that review drugs, biologics, animal health, tobacco, and medical devices into a single regulatory office would lead to major challenges.