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  5. The Office of Prescription Drug Promotion (OPDP)
  1. Center for Drug Evaluation and Research | CDER

The Office of Prescription Drug Promotion (OPDP)


Office Contact Information

10903 New Hampshire Ave., Building 51, Room 3203
Silver Spring, MD 20993-0002
Phone: 301-796-1200
Fax: 301-847-8444 or 301-847-8445

Mission

OPDP protects the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. This is accomplished through comprehensive surveillance, compliance, research, and education programs, and by fostering better communication of labeling and promotional information to both healthcare providers and consumers.


On April 24, 2024, the U.S. Food and Drug Administration issued a revised draft guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers.”

FDA is issuing this revised draft guidance to address questions that manufacturers, packers, distributers, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products and prescription biosimilar products, including interchangeable biosimilar products, licensed under the Public Health Service Act (PHS Act). In conjunction with the enactment of the Biosimilar User Fee Amendments of 2022 (BsUFA III), FDA committed to publishing a draft guidance on promotional labeling and advertising considerations for interchangeable biosimilar products on or before September 30, 2024, as described in the document entitled “Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027.” The revised draft guidance fulfills this commitment and replaces the draft guidance for industry entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers” issued in 2020.


Information About What OPDP Reviewers Do

OPDP reviewers have the 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 compliance letters 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. 

The Bad Ad Program

FDA's Bad Ad Program is an outreach program designed to help healthcare providers recognize potentially false or misleading prescription drug promotion. The program’s goal is to raise awareness among healthcare providers including physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and trainees about potentially false or misleading prescription drug promotion while also providing them with an easy way to report it to the Agency.

OPDP Submission Information

OPDP Resources




 

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