Q: What are the differences, if any, between the draft guidance and the final guidance concerning consumer-directed (direct-to-consumer or DTC) broadcast advertisements?
A: The final guidance does not differ substantially from the draft guidance. Minor revisions include: (1) reformatting the assumptions underlying what constitutes a compliant broadcast advertisement in general; (2) deleting the option under the toll-free telephone component of the adequate provision approach to offer to fax product labeling to consumers; (3) emphasizing the need for the print advertisement component of the adequate provision approach to be broadly disseminated; (4) acknowledging that the print brochures alternative component of the adequate provision approach was likely to be feasible only when broadcasting was fairly limited in scope; (5) acknowledging explicitly that healthcare providers other than physicians and pharmacists can be sources of additional human drug product information; and (6) adding a discussion to clarify the differences in satisfactory adequate provision approaches for telephone advertisements, compared with television or radio advertisements.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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