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
Email: CDER-OPDP-RPM@fda.hhs.gov

Contact OPDP

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.

What We Do

OPDP is an office of diverse professionals dedicated to supporting our public health mission. These professionals include reviewers, health science policy analysts, regulatory counsels, social scientists, and project managers.

OPDP’s 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 (1) providing written comments to pharmaceutical sponsors on proposed promotional communications to ensure clear and unambiguous communication of the laws and regulations relating to prescription drug promotion, (2) reviewing complaints about alleged promotional violations, (3) initiating compliance letters on promotional communications that are false or misleading, (4) comparing the product labeling and promotional communications of various closely related products to ensure that the regulatory requirements are consistently and equitably applied, (5) traveling to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities, and (6) acting as a liaison between OPDP and other divisions within the FDA on promotional issues.

OPDP’s health science policy analysts focus on policy development initiatives, including the drafting and publication of guidance documents related to prescription drug promotion. Regulatory counsels are responsible for legal analysis and regulatory initiatives across OPDP, and project managers provide operations and program support to all of OPDP.

OPDP also has an active research program designed to investigate applied and theoretical issues of relevance to direct-to-consumer and health care provider-directed promotional prescription drug communications. This research program uses several different research methodologies, including survey and experimental research as well as qualitative research for development purposes. OPDP’s research supports FDA’s goal of science-based decision-making in service of our commitment to protect the public health. The OPDP Research Team also provides technical assistance to outside organizations on the design and implementation of studies concerning prescription drug promotion. Some of these organizations include academic researchers, pharmaceutical companies, and nonprofit groups.