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
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, and education programs, and by fostering better communication of labeling and promotional information to both healthcare providers and consumers.
A revised Final Guidance for industry titled “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs” was posted on April 11, 2022.
The following changes related to regulatory submissions in electronic and non-electronic format are included in the Final Guidance:
- Footnote 12 has been updated to include the link to the FDA Forms webpage.
- Footnote 14 has been updated to include directions for requesting the current OPDP reviewer assignment through the OPDP Regulatory Project Manager Mailbox.
- References to Box 14 on the Form FDA-2253 have been removed. The box numbering on the Form FDA-2253 was updated during the April 2021 revision of the Form and Box 14 was renumbered to Box 13. All references to the box numbering have been removed and the box is now referenced by title – “For CBER Products Only.”
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 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