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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 'Final Rule: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products' (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.
According to the FDA's press release, the 'new format requires that prescription information for new and recently approved products meet specific graphical requirements and includes the reorganization of critical information so physicians can find the information they need quickly.' The rule is described by the agency as 'an effort to better manage the risks of medical product use and reduce medical errors associated with the use of prescription drug products.' (FDA Announces Final Rule on Requirements for Prescribing Information for Drug and Biological Products. FDA News, Jan. 18, 2006.) Health professionals and consumer advocacy groups have long urged the need for changes to the format in which prescription drug information is provided to physicians. Currently, package inserts are far from user friendly with agonizingly small print and hundreds of different pieces of information loosely organized under different subjects through numerous pages. The current format allows important information regarding adverse events and potential risks to become easily 'buried' within a tome of information.
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