Drugmakers should submit proposed direct-to-consumer television ads to the FDA Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research for review before airing them, according to a draft guidance from the agency. The FDA has 45 days from the date a complete package is received for review and will notify the sponsor if the review will not be completed on time. "This guidance creates an FDA 'shot clock' that doesn't allow you to take a shot at broadcast marketing for an additional 45 days," said Coalition for Healthcare Communication Executive Director John Kamp.

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