Second Circuit rejects FDA regulation of “off-label” promotion as misbranding in Caronia case *

USA - December 3 2012
In a widely anticipated ruling, the United States Court of Appeals for the Second Circuit this morning reversed the conviction of pharmaceutical sales representative Alfred Caronia for misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA), based on alleged “off-label” promotion.

Co-authors: Paul E. Kalb, M.D, Coleen Klasmeier.

FDA reorganization furthers pro-enforcement agenda, reflects global focus *

USA - July 18 2011
On July 13, 2011, Commissioner of Food and Drugs Dr. Margaret A. Hamburg announced a reorganization to create new “directorates” overseeing the core functions and responsibilities of the agency.

Co-authors: Nicholas K. Wimbush, Coleen Klasmeier.