Practice Tip

The Bush administration has adopted a new tactic in its ongoing efforts to create liability shields on behalf of various industries, including the pharmaceutical industry. Despite a number of failed legislative attempts at tort reform, on Jan. 18, the administration quietly enacted its own liability-shield agenda under the guise of federal pre-emption. A new U.S. Food and Drug Administration ('FDA') rule titled <i>'Final Rule: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products'</i> (21 C.F.R. 201, 314 and 601), which goes into effect on June 30, 2006, extensively modifies the format of prescription drug information, commonly referred to as the 'package insert' and published in the Physician's Desk Reference', and will come with an attempt at broad federal pre-emption.

27 minute read April 28, 2006 at 01:52 PM

By

Perry Weitz And Shannon Sneed