Proposed guidelines from the U.S. Food and Drug Administration (FDA) would allow companies to market more drugs for unapproved uses and are a step in the wrong direction, said a researcher from the Stanford University School of Medicine.
In an editorial published in the April 3 issue of The New England Journal of Medicine, Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, criticized the draft guidelines, which were subject to public comment through April 21. They curtail the FDA's already limited authority over the marketing of drugs for off-label uses, Stafford said.To read the full story in the May 2008 issue of the APPI Bulletin, click here.For more information about the APPI Bulletin, click here.