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FDA DRAFTING LAUNCH AD CAMPAIGN REVIEW "GUIDANCE DOCUMENT

Executive Summary

FDA DRAFTING LAUNCH AD CAMPAIGN REVIEW "GUIDANCE DOCUMENT, to make sponsors aware of the requirements and expectations of the Division of Drug Marketing Advertising & Communications. A DDMAC/Pharmaceutical Manufacturers Association task force met Oct. 13 to consider the launch campaign review process and revisions to FDA's Form 2253, for reporting ad materials to the agency. The task force and DDMAC will draft launch review guidance documents concurrently. DDMAC will then issue a guidance document that incorporates the best parts of the two drafts. DDMAC expects to complete the launch review policy guidance in about two months. The task force comprised FDAers DDMAC Acting Director Lucy Rose, Norin Drezin, Heidi Marchand, Warren Rumble, Chet Trybus and Ed Zimney. Industry representatives in the group were Berlex Labs' Tony Bourdakis, PMA's Tom Copmann, Lederle's Vern DeVries, Zeneca's Tony Rogers, DuPont Merck's Preeti Pinto and SmithKline Beecham's Bob Powell. DDMAC is understood to be willing to review launch materials based on draft labeling if the review division agrees that the draft essentially represents what will be the final labeling. Additionally, materials can be submitted in black and white but should be reasonable facsimiles of the actual piece, showing the layout, shading, size of copy and footnotes, warnings and figures. Task force members are asking sponsors to keep materials submitted for review to a minimum. If separate, essentially duplicate pieces are submitted for preclearance, they must be reviewed separately. Supporting materials should be referenced, and the hard copy should be included in the submission package. The hard copy should highlight specific supporting text, the task force agreed. Additionally, each page of reference material should be numbered. DDMAC is advising sponsors to abjure face-to-face meetings for dispute resolution and is recommending instead that companies employ teleconferencing or video-conferences as the most expeditious, time-saving method for resolving conflicts about ad programs. The task force favors a "first-in, first-out" policy review process and agreed that sponsors should supply duplicate copies of launch materials to DDMAC and to the Therapeutic Review Division to accelerate the review process. The task force also agreed to provide DDMAC with a proposed revised draft of FDA 2253 that streamlines and condenses the form. There was also agreement that it would be in the best interests of the agency and the industry if the Center for Biologics Evaluation & Research and the center for drugs both use a common form.
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