The Office of Prescription Drug Promotion (OPDP)
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
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 June 27, 2023, the FDA issued a final guidance for industry entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” This guidance finalizes the draft guidance issued in October 2018. The guidance provides recommendations for presenting quantitative efficacy and risk information in DTC promotional labeling and advertisements for prescription human drug and biological products, prescription animal drugs, and in DTC promotional labeling for nonprescription animal drugs (collectively, “promotional communications”). The recommendations are informed by current research findings related to communicating health information and cover the following topics:
- Providing quantitative efficacy or risk information from the control group, when applicable;
- Presenting probability information in terms of absolute frequencies, percentages, and relative frequencies;
- Formatting quantitative efficacy or risk information; and
- Using visual aids to illustrate quantitative efficacy or risk information.
The guidance outlines recommendations for how manufacturers, distributors, and packers (collectively, “firms”) that include quantitative efficacy or risk information in DTC promotional communications for their drugs can make the language and presentation more consumer-friendly.
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 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.
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
- OPDP News
- OPDP Frequently Asked Questions (FAQs)
- For Industry: Using Social Media
- OPDP Research
- Contact OPDP
- OPDP Regulatory Information
- Truthful Prescription Drug Advertising and Promotion
- OPDP Metrics
- OPDP eCTD