Summaries of health policy coverage from major news organizations
FDA Issues Advertising Guidelines on Product Risk Information
FDA on Tuesday posted on its Web site advertising guidelines for drugmakers and medical device manufacturers, offering suggestions on how to present risk information to health care professionals and consumers, the Wall Street Journal reports. Agency officials said the industry had asked for guidance on how to comply with its rules, which require a balanced presentation of a product's risk and effectiveness. Exclusion or minimization of risk information is the most commonly cited violation each year in FDA-issued warnings or enforcement letters. The new guidelines include detailed information on how aspects such as font, types of contrast and white space in print materials can appropriately present risk information. According to the Journal, the 24-page document is not binding. FDA will accept public comments for 90 days prior to issuing final guidelines (Corbett Dooren, Wall Street Journal, 5/27).
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