PharmacoEconomics & Outcomes News 296 - 20 Jan 2001

■ The US FDA* has proposed a new format forprescription drug labelling in an attempt to reducemedical errors; such errors may be responsible for asmany as 98 000 deaths in the US annually, accordingto the National Academy of Sciences. The FDA’sproposal came following the findings of an FDA studywhich revealed that practitioners found drug productlabelling complex, lengthy and hard to use. Dr JaneHenney, FDA Commissioner, says that ‘this proposal isparticularly valuable because it will make importantinformation available in a clear, consistent, andreadable format that is essential to proper prescribingpractices’. The proposed new format, which includes anew introductory ‘Highlights’ section, will allowpractitioners to quickly find the most importantinformation about the product. The FDA says that theproposal will only apply to relatively new prescriptiondrug products.* Food and Drug Administration

Food and Drug Administration. Physician labeling proposal. Media Release :[1 page], 21 Dec 2000. Available from: URL: http://www.fda.gov 800852256

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PharmacoEconomics & Outcomes News 20 Jan 2001 No. 2961173-5503/10/0296-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved