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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 at http://www.fda.gov/cder/ddmac/submissions.htm
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 http://www.fda.gov/cder/ddmac/user_fees/default.htm.
