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.
Core Launch Updates
On November 20, 2020, OPDP hosted a webinar to provide an overview of the upcoming changes to the OPDP Core Launch Review process. The webinar will provide information to:
- Identify promotional materials that qualify for Core Launch Review within the OPDP Advisory Process
- Understand the changes to the Core Launch Review process and incorporate those changes into existing promotional material development strategies
- Utilize the various resources provided by OPDP to support the Core Launch Review process
The recorded webinar is available at the link below.
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 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
Learn More About OPDP
- OPDP Reflects on 2020, Looks Forward to 2021 as It Helps Ensure Prescription Drug Promotion Is Truthful, Balanced and Accurate