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If the FDA seeks to have greater success in the future in regulating DTC advertising, it needs to take several steps. First, the agency needs to develop clear standards and procedures for determining when exactly a DTC advertisement is to be considered ldquo;false or misleading. rdquo; Second, the agency has to be creative in defining new and substantial interests that it can assert to justify regulating drug manufacturer speech. This is no easy task, given that a wide variety of rationales for regulation have already been asserted before the courts, and nearly all of them have been struck down.]