Lawmaker Protests New FDA Guidelines
Published by Food and Drug Administration News December 1st, 2007 in Uncategorized“It’s not a radical change. It’s not a new loophole.”
The Bush administration is poised to give drug and medical device companies new leeway to use scientific journal articles to promote their products for unapproved uses, a Democratic lawmaker said Friday.
The Food and Drug Administration generally prohibits manufacturers from marketing products for any off-label use _ those uses that have not been approved as safe and effective. Since 1997, however, Congress has made an exception for journal articles. That law recently expired, and now, the agency is trying to put voluntary guidelines in place. Read more