Personal Injury Law

Could Drugmakers Use Journals to Promote Off Label Use?

By Peopleslawyer

Drug and medical-device makers would be allowed to use medical journal articles to promote unapproved uses of their products under a U.S. proposal that drew immediate criticism on Capitol Hill.

The Food and Drug Administration issued draft guidelines today explaining the circumstances in which companies could distribute ``truthful and non-misleading'' articles to health- care providers.

Makers of drugs and devices aren't permitted to promote their products for conditions not approved by the FDA, although doctors are free to prescribe such ``off-label'' uses. Representative Henry Waxman, a California Democrat, said the FDA's proposal ``caters to the industry's desire'' to market products without enough testing or review.

Source here.

Full post as published by A Georgia Lawyer on February 18, 2008 (boomark / email).