Washington Report: Labels and Liability

The food and drug administration started 2006 with a bang, unveiling a long-anticipated final rule that significantly overhauls the way drugs and biologics are labeled. This new regulation, designed to improve the communication of risks and benefits, has been in the works for years, but has been delayed by industry concerns that it could expose companies to more liability suits. Implementation will be a massive, costly undertaking, but at this point industry has little choice but to comply.

This final decision on the format and content of professional labeling sets the stage for FDA to move forward with other initiatives. For example, the agency recently required manufacturers to submit all labeling

Reducing Research Failures

in electronic form. That process should finally move ahead now that FDA has eliminated uncertainty about label design. Similarly, it will now be safer and easier for manufacturers to simplify the brief summary that accompanies print advertising, as FDA wants: The "highlights" section at the beginning of the new label provides a model for developing briefer and more consumer-friendly prescribing information.

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