About FDA

The Office of Prescription Drug Promotion (OPDP)

(formerly Division of Drug Marketing, Advertising and Communications - DDMAC)

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Office Location

10903 New Hampshire Ave., Building 51, Room 3203
Silver Spring, MD 20993-0002

Phone and Fax Numbers

Phone: 301-796-1200
Fax: 301-847-8444 or 301-847-8445


"To protect the public health by ensuring that 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." 

FDA Issues Guidance for Industry: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements Draft Guidance on October 16, 2018
FDA issued a draft guidance for industry entitled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.  This draft guidance provides recommendations for presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements for prescription human drugs and biological products and prescription animal drugs and in DTC promotional labeling for over-the-counter (OTC) animal drugs (collectively promotional materials).  For the purposes of this guidance, quantitative efficacy and risk information refers to information that numerically addresses the likelihood or magnitude of a drug’s effectiveness or risks. FDA is issuing this draft guidance to describe the Agency's recommendations for how manufacturers, packers and distributors that include quantitative efficacy or risk information about their drugs in DTC promotional materials can make the language and presentation more consumer-friendly.  For more information about the guidance, see the Notice of Availability.

FDA 2253

The Office of Prescription Drug Promotion (OPDP) reminds you to use the current Form FDA-2253 [PDF] and instructions [PDF].  Visit the OPDP Form FDA-2253 and Request for Advisory Comment Submissions page for additional information.

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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?

Providing Regulatory Submissions in Electronic and Non-Electronic Format

Please see the draft guidance for information on electronic (including eCTD) and non-electronic submissions.  FDA is expected to begin accepting eCTD submissions using the new M1 specifications as of June 15, 2015.  Please refer to the eCTD webpage for details.

For technical questions on eCTD format for CDER, please refer to the eCTD webpage or contact esub@fda.hhs.gov.  For questions regarding the guidance or eCTD submissions to OPDP, please contact OPDPeCTD@fda.hhs.gov.

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.

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OPDP Submission Information

Information on the components of a complete and reviewable DTC TV submission package, and for information on other submissions.

Page Last Updated: 12/12/2018
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