WASHINGTON - A U.S. federal court has swept away most restrictions imposed by the FDA Modernization Act on the ability of drug and device manufacturers to engage in the distribution of off-label product information through peer-reviewed literature, textbooks or seminars. Unless the ruling is reversed by an appeals court, FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) will be forced to dramatically alter its regulation of drug promotion and marketing, according to attorneys who specialize in FDA law.

The new ruling, which took effect immediately, reaffirms a year-old judicial decision in a case brought against FDA by the Washington Legal Foundation (WLF). The 1998 decision allowed manufacturers to send peer reviewed papers, and chapters from reference and textbooks to physicians without prior review or approval by FDA.