Consumer-Directed Broadcast Advertisements Questions and Answers
Q: What are the differences, if any, between the draft guidance and the final guidance concerning consumer-directed (direct-to-consumer or DTC) broadcast advertisements?
A: The final guidance does not differ substantially from the draft guidance.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)
If unable to submit comments online, please mail written comments to:
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Food and Drug Administration
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All comments should be identified with the title of the guidance.