Resources for You
- OPDP Research
- Truthful Prescription Drug Advertising and Promotion (Bad Ad)
- OPDP Complaints
- First Report to Congress on the Implementation of Section 3507 of the Patient Protection and Affordable Care Act of 2010 (PDF - 227KB)
Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs
The Office of Prescription Drug Promotion (OPDP)
(formerly Division of Drug Marketing, Advertising and Communications - DDMAC)
10903 New Hampshire Ave., Building 51, Room 3200
Silver Spring, MD 20993-0002
Phone and Fax Numbers:
Fax: 301-847-8444 or 301-847-8445
"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."
OPDP has transitioned to a new tracking system. There are new requirements when submitting requests for advisory. For more information, please refer to the following:
- OPDP Submission of Proposed DTC TV Ads for Advisory Review
- Requests for Advisory Comment on Promotional Materials Other than Proposed DTC TV Ads
New Form FDA-2253
OPDP Enforcement Actions Webinar – January 30, 2014 at 11:30 AM
The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) invites you to participate in the next Enforcement Webinar on January 30, 2014, from 11:30 AM to 12:00 PM (ET). Viewers can begin submitting questions 30 minutes prior to the webinar start time. During the webinar, OPDP will give stakeholders a chance to directly communicate with the Agency about clarifications or questions concerning recent Warning Letters and Untitled Letters issued by OPDP. This particular webinar will cover Warning Letters and Untitled Letters issued from July 2013 through December 2013. The October Webinar has been canceled due to the Government shutdown. The Enforcement and Warning Letters from the October Webinar will be included in the January Webinar.
These focused webinars support OPDP's mission to protect the public health by assuring that prescription drug information is truthful, balanced, and accurately communicated.
To join the meeting: https://collaboration.fda.gov/opdp1028
Risk Communication Advisory Committee; Notice of Meeting
Information About What OPDP Reviewers Do
OPDP 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 OPDP and other divisions within the FDA on promotional issues. Interested in a position at OPDP?
Important Information About Submissions
OPDP 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 OPDP Advisory Review
Please visit OPDP’s submission page for information on the components of a complete and reviewable DTC TV submission package, and for information on other submissions. OPDP’s submissions web page is available below.
Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)
The Prescriber's Role - Recognize and Report
FDA's educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.
The "Bad Ad" Program is administered by the agency's Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research. It will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.
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
OPDP Submission Information
Information on the components of a complete and reviewable DTC TV submission package, and for information on other submissions.