FDA issues new labeling rules

The FDA has announced major changes to its prescription drug labeling rules. The changes are intended to prevent medical errors by reducing the potential for confusion. Under the new regulations, drug labels will carry a highlighted section that summarizes known risks and includes information on recent changes. Officials at the agency say the new rules will likely lead to major changes in direct-to-consumer pharma advertising as well, as advertisers drop much of the fine print that now takes up TV air time.

Although many of the rule's changes are clearly well intentioned, they also will have a significant impact on pharmaceutical liability law, critics argue. Some  believe the new labeling requirements will make it easier for drug companies to dodge product liability suits.

- see this article from the Boston Globe

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