CIAO DATE: 07/2008
May 2008
American Enterprise Institute for Public Policy Research
In this article, AEI resident fellow Scott Gottlieb, M.D., describes how information about a new use of the breast cancer drug Herceptin was slow in reaching oncologists. The Food and Drug Administration (FDA) delayed approving the new indication for almost two years, and during that period, the drug's sponsor could not distribute its findings about the new use. Proposed FDA guidelines on dissemination of information on unapproved uses of medical products, Gottlieb says, will establish a more appropriate standard for what kind of information should be shared.
Resource link: A Good Framework for Distributing Information on Off-Label Uses [PDF] - 60K