(formerly Division of Drug Marketing, Advertising and Communications - DDMAC)
10903 New Hampshire Ave., Building 51, Room 3203
Silver Spring, MD 20993-0002
Phone and Fax Numbers:
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."
OPDP Issues Draft Guidance on Providing Regulatory Submissions in Electronic and Non-Electronic Format
On April 21, 2015, OPDP issued a draft guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs. This draft guidance describes the various types of submissions of promotional materials and general considerations for submissions. In addition, this draft guidance discusses the specific aspects of submission of promotional materials using module 1 of the electronic Common Technical Document (eCTD) using version 3.3 or higher of the us-regional-backbone file to OPDP or to the Center for Biologics Evaluation and Research's Advertising and Promotional Labeling Branch (APLB) under section 745(a) of the Federal Food, Drug, and Cosmetics Act. Within 24 months of the publication of the final version of this guidance, all submissions under section 745(a) must be made electronically using the eCTD specifications.
OPDP Issues Revised Draft Guidance on Brief Summary and Adequate Directions for Use Requirements
On February 6, 2015, OPDP issued a revised draft guidance entitled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs. The revised draft guidance responds to stakeholder requests for specific guidance on disclosure of risk information to consumers and incorporates recent social science research results. This revised draft guidance pertains to what is commonly known as the “brief summary requirement” for consumer-directed print advertisements and to the requirement that certain information be included with consumer-directed print promotional labeling pieces for human prescription drugs and biologics. The guidance revises the January 2004 draft guidance entitled Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements. The revised draft guidance was reissued on August 5, 2015 to incorporate prescription animal drugs Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs. Commenters that provided input on the February 2015 guidance do not need to resubmit comments as these have been received and will be evaluated. There are no other changes to the February 2015 revised draft guidance beyond the addition of the prescription animal drugs.
Form 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 Reguest for Advisory Comment Submissions page for additional information.
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 email@example.com. 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.
OPDP Submission Information
Information on the components of a complete and reviewable DTC TV submission package, and for information on other submissions.