[DDMAC] Division of Drug Marketing, Advertising, and Communications

Division of Drug Marketing, Advertising, and Communications (DDMAC)
Description

New Office Location:
10903 New Hampshire Ave., Building 51, Room 3200
Silver Spring, MD 20993-0002

New Phone and Fax Numbers:
Phone: 301-796-1200
Fax: 301-847-8444 or 301-847-8445

Mission

"To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers."

Information About What DDMAC Reviewers Do

DDMAC reviewers have responsibility for reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading. They engage in a variety of tasks to perform this responsibility, including: providing written comments to pharmaceutical sponsors on proposed promotional materials to ensure clear and unambiguous communication of the laws and regulations relating to prescription drug promotion; reviewing complaints about alleged promotional violations; initiating enforcement actions on promotional materials that are false or misleading; comparing the product labeling and promotional materials of various closely related products to ensure that the regulatory requirements are consistently and equitably applied; traveling to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities; and acting as a liaison between DDMAC and other divisions within the FDA on promotional issues.

Important Information About Submissions

DDMAC reminds all companies who are engaging in DTC advertising of prescription drugs that the requirements of section 906 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) went into effect on March 25, 2008. Section 906 of FDAAA mandates that published direct-to-consumer advertisements for prescription drugs include the following statement printed in conspicuous text: "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088."

Proposed DTC TV Advertisements Voluntarily Submitted for DDMAC Advisory Review

Please visit DDMAC’s submission page for information on the components of a complete and reviewable DTC TV submission package, and for information on other submissions. DDMAC’s submissions web page is available below.

Information about the status of the DTC user fee program enacted under the Food and Drug Administration Amendments Act of 2007 (FDAAA) is posted at the

Direct-to-Consumer (DTC) Television User Fee Program Documents page.

Direct-to-Consumer (DTC) Television User Fee Program Documents


1/15/2008: The Food and Drug Administration (FDA) is issuing this notice to inform companies that the Direct-to-Consumer (DTC) television advertisement user fee program will not commence because the necessary user fees for the program were not "provided in advance in appropriations Acts" as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA). Federal Register notice [HTML] [PDF]

If you have questions about the DTC user fee program or about submitting DTC TV ads for advisory review, please contact either Mr. Wayne Amchin or Mr. Paul Loebach at (301) 796-1200.

Proposed DTC TV Advertisements Voluntarily Submitted for DDMAC Advisory Review

Since the DTC User Fee Program will not be implemented, all direct-to-consumer (DTC) television advertisements voluntarily submitted for DDMAC 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.

Companies planning to send more than one proposed DTC television advertisement to DDMAC for advisory review should not consolidate them into one submission. 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.

What Constitutes a Complete and Reviewable DTC TV Submission?

Please visit DDMAC’s submission page for information on what constitutes a complete and reviewable DTC TV submission, and for information on other submissions. DDMAC’s submissions web page is available at Submission of Proposed DTC TV Ads for Advisory Review.

Federal Register Documents Concerning the DTC User Fee Program

DTC User Fee Program Will Not be Implemented [HTML] [PDF] (1/16/08)
User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products; Request for Notification of Participation and Number of Advertisements for Review [HTML] [PDF] (posted 10/25/2007)
Federal Register Notice: Establishment of Fiscal Year 2008 User Fee Rates for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products. [HTML] [PDF] (12/13/2007)