At the present time, DDMAC is not accepting electronic submissions through the GATEWAY Portal
Recommendations on Specific Types of Submissions
Submission of Proposed DTC TV Ads for Advisory Review
What constitutes a complete and reviewable submission?
Proposed DTC TV advertisements submitted for advisory review should include the following information and documents as part of the submission:
- Cover letter:
- Subject line that states "Request for Advisory Comments on Proposed DTC TV ad", the NDA/BLA number, Proprietary Name/Established Name (dosage form)”, and the name of the advertisement.
- The letter should also indicate whether DDMAC has previously commented on this ad, the comment date, and the MACMIS#.
- Contact name, title, address, phone, fax, and email of the person that DDMAC should contact about issues related to the submission.
- Generally send 10 copies of:
- Annotated Storyboard, with sequentially numbered frames, to show which references support which claims
- Annotated current Approved Package Insert /Medication Guide/Patient Package Insert, all cross-referenced to the storyboard
- Annotated references to support product claims not contained in the labeling, cross referenced with the storyboard
- Annotated references to Support Disease and Epidemiology Information
- Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate.
- Official translation for proposed foreign language DTC television advertisements
- For new drugs or indications, or drugs in a class advertised on TV for the first time, please send 17 copies of the items above.
- Optionally, submissions for advisory review may include a video or animatic of the proposed advertisement. Please submit two copies of such material in one of the following media formats:
- MPEG-2-HD (High Definition Video)
- WMV-HD (High Definition Video)
- DVD-VR
- DVD+VR
- DVD-Video
- Mini-DVD
- CD-R and CD-RW
- VHS
- Please Note: the following file formats are acceptable:
- .iso files
- Audio_ts/video_ts folders that include the following formats:
Companies planning to send more than one proposed DTC television advertisement to DDMAC for advisory review should not consolidate them into one submission. Instead, each proposed DTC television advertisement for advisory review should be submitted separately (not bundled together), and each submission should be complete and reviewable as a stand-alone submission. A submission should not rely on references or other materials previously provided to FDA or submitted as part of another submission.
Please be advised that other promotional material should NOT be bundled together with submissions of proposed DTC TV ads for advisory review (for example, companies should no longer send a print advertisement in a package with a proposed DTC TV advertisement for advisory review).
Proposed DTC TV ads for advisory review should be sent directly to FDA’s central document room to the attention of DDMAC’s Project Management Team. Please send these submissions to:
Wayne Amchin
Project Manager
Division of Drug Marketing,
Advertising and Communications
Food and Drug Administration
Center for Drug Evaluation and Research
5901-B Ammendale Road
Beltsville, MD 20705-1266
Attention: DTC TV Ad for Advisory Review
DDMAC strongly encourages companies to note on the exterior package that the submission is a proposed DTC TV ad for DDMAC advisory review. Companies with questions about submission of proposed DTC TV advertisements should contact Wayne Amchin or Paul Loebach at 301-796-1200 or by email at dtcp@fda.hhs.gov.
Requests for Advisory Comment on Promotional Materials Other than Proposed DTC TV Ads
Advisory comments can be requested on draft promotional pieces that have not been published or disseminated and are not currently in use. With the exception of draft DTC TV ads, draft promotional materials submitted for advisory comment can be bundled together into one submission. We suggest that these materials be consolidated into single submissions to the extent possible rather than sending the materials piecemeal in several submissions over the course of a few days/weeks. However, please submit professional and direct-to-consumer materials separately. This approach will help to ensure that the proposals are reviewed in a timely manner. Materials should be provided in triplicate unless otherwise specified. Please do NOT include Form FDA-2253 or 356H.
Please include in the submission:
- Cover letter stating your request for advisory comments
- Include "Request for Advisory Comments" in the subject line of the cover letter
- Draft promotional materials including annotations to references
- Annotated supporting references
- Annotated current Approved Package Insert/Medication Guide/Patient Package Insert
These submissions to DDMAC should be sent to the FDA central document room at the following address:
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Drug Marketing, Advertising, and Communications
5901-B Ammendale Road
Beltsville, MD 20705-1266
To help avoid misdirection of your promotional materials intended for DDMAC, DDMAC suggests applying a "DDMAC" sticker [example sticker (PDF) 
] or other prominent directional notation to the exterior of packages submitted to DDMAC. If it is not possible to add this notation to the exterior of the package, DDMAC recommends adding a prominent directional notation (e.g., sticker, rubber stamp, etc.) to the cover letter itself. This notation should also be used on packages containing a DDMAC submission and additional desk copies of the same material intended for another division within FDA.
Note: For any time sensitive materials other than proposed DTC TV advertisements, please confirm receipt of the submission by DDMAC with a phone call to the relevant DDMAC reviewer or the DDMAC project manager at 301.796.1200. To confirm receipt of DTC TV advertisements submitted for advisory review, contact the DDMAC project manager at 301.796.1200 or by email at dtcp@fda.hhs.gov.
Form FDA-2253 submissions
According to 21 CFR 314.81(b)(3)(i), all advertisements and promotional labeling for a particular drug product must be submitted at the time of initial publication or dissemination. Each submission is required to be accompanied by a completed transmittal Form FDA-2253. Please submit professional and direct-to-consumer materials separately. Please do NOT include a cover letter. All materials, both paper and electronic format, must be submitted in duplicate. Please be sure to use the most current version of Form FDA-2253, available below on this website. NOTE: A revised version of this form will be available in May 2008.
Please include in the submission:
- Form FDA-2253 - Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use [PDF]
- For CDER Biologic Drug Products: On Form FDA-2253, Box 13 titled "Biological Products," please do NOT check the "Part I/Draft" or "Part II/Final" boxes. This form should be submitted with FINAL promotional materials only.
- Promotional materials - Materials can be submitted in paper or electronic format. Please consult the following draft guidance for information on submitting materials in electronic format:
- Draft Guidance - "Guidance for Industry Providing Regulatory submissions in Electronic Format -- Prescription Drug Advertising and Promotional Labeling" (1/31/01) [HTML] [PDF]
- Current approved Package insert and, if applicable, Medication Guide/Patient Package Insert
Complaints
Please submit complaints regarding professional and direct-to-consumer materials separately. A duplicate copy of the submission should be provided. Please do NOT include Form FDA-2253 or 356H.
Please include in the submission:
- Cover letter identifying the drug, manufacturer, promotional materials and violations
- Include "Complaint" in the subject line of the cover letter
- Promotional materials
Part 99 Applications
Please be aware that Section 401 of the FDA Modernization Act of 1997, 21 U.S.C. § 360aaa, et seq., ceased to be effective on September 30, 2006. As a result, we are no longer evaluating whether information to be disseminated about unapproved/ new uses is consistent with the provisions of 21 CFR Part 99.
