FDA Suggests New Leeway for Consumer Drug Advertising The FDA is proposing a new tradeoff for direct-to-consumer advertising of prescription drugs. The FDA now requires that a print advertisement of a particular brand-name drug and its uses contain all the fine-print contraindications and side-effect cautions that must be included in the package insert. In fact, many ads simply reprint the package inserts verbatim. This satisfies FDA rules, but some staffers argue that it may not be the best way to help patients. "This labeling is written for health professionals, using medical terminology," a new FDA draft guideline notes, and so "may be difficult for consumers to understand. "The following compromise has been proposed: if a drugmaker uses language more accessible to laymen in outlining possible problems with the drugs, the FDA will pull back from what cautions are required. The ads would still have to include all contraindications, warnings, and major precautions but would be able to omit mention of side effects that occur infrequently and are not serious, information related to such special populations as children and pregnant or breast-feeding women, and "information related to carcinogenesis, mutagenesis, and infertility that does not warrant a discussion under the Warnings section." The language would have to get FDA approval as patient labeling. As a benchmark, the draft guidelines suggest that approvals already given to patient labeling for such drugs as Glucophage, Fosamax, Evista, Ziagen, and Xenical would suffice. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.