OPDP: Office of Prescription Drug Promotion

The Office of Prescription Drug Promotion, OPDP, is a division within the FDA’s Center for Drug Evaluation and Research, or CDER. OPDP’s primary mission is to protect the public health by ensuring that prescription drug information disseminated by pharmaceutical companies is truthful, balanced, and not misleading. They achieve this by reviewing promotional materials, conducting surveillance, ensuring compliance, taking enforcement actions when deemed necessary, researching, and aiming to foster better communication of labeling and promotional information to both healthcare providers and patients.¹ OPDP holds oversight authority for the messaging and overall content of promotional materials created by pharmaceutical companies. 

Previously known as the Division of Drug Marketing, Advertising, and Communications, OPDP was rebranded in 2011 to reflect the organization’s core function. The office has evolved and adapted its oversight in response to the growth of direct-to-consumer, or DTC, advertising as well as evolving media formats. As pharmaceutical marketing became more sophisticated, OPDP’s role expanded to ensure promotional content is aligned with the law and accurately represents a product’s risks and benefits.

OPDP engages in the following to ensure promotional materials are truthful and not misleading:¹

OPDP follows many regulations to conduct and maintain its oversight authority. Two crucial regulations are the Federal Food, Drug, and Cosmetic Act (FDCA) section 502(n) and Title 21 of the Code of Federal Regulations Part 202.1 (21 CFR 202.1). Section 502 deems a drug misbranded if its labeling is false or misleading. Both regulations require that promotional materials and their messaging are consistent with a product’s FDA approved label. In other words, promotion must be truthful. In addition, the regulations require that promotional materials provide a fair balance of a product’s benefits and risks. Both regulations require that the promotion must include a "brief summary" that outlines the drug's side effects, contraindications, and effectiveness.² In practice, this means pharmaceutical companies must present both benefits and risks of a drug in a balanced manner and avoid overstating efficacy, minimizing safety concerns, or suggesting uses that are not explicitly stated on the FDA approved label. In other words, product promotion must be non-misleading. 

OPDP reviews a wide range of promotional materials, including television and print advertisements, digital media, brochures, and sales aids used by drug manufacturers.³ These materials must comply with FDA regulations on fair balance, substantiation, and proper representation of clinical data. OPDP will utilize enforcement actions for companies that do not comply with regulations. Two common enforcement tools are Untitled Letters and Warning Letters. Untitled Letters cite violations that the FDA deems less severe than one that would warrant a Warning Letter. Warning Letters indicate more significant violations and may prompt further legal or regulatory actions if unaddressed by the company. In severe cases, OPDP can escalate matters to the Department of Justice, leading to product recalls or fines.

Along with enforcement, OPDP plays an important educational role. It offers guidance to industry stakeholders on how to comply with promotional regulations and often engages with pharmaceutical companies through advisory meetings. These meetings allow companies to receive feedback on planned campaigns, including launch materials for a New Drug Application approval or label expansion. OPDP also produces public guidance documents and research findings to help clarify expectations across the pharmaceutical industry. In addition, OPDP leads the Bad Ad Program to help healthcare providers recognize potentially false or misleading prescription drug promotion. The program includes resources for the public to report potentially misleading promotional materials, courses, webinars, and case studies of real examples of misleading prescription drug promotion. OPDP regularly presents at conferences and hosts public workshops to foster dialogue about ethical drug promotion. While OPDP’s role is regulatory, it aims to be transparent and collaborative for industry professionals navigating compliance in an ever-changing marketing environment.

As pharmaceutical promotion becomes more online, OPDP faces complex challenges in regulating digital and social media platforms. OPDP has issued guidance documents that aim to simplify risk disclosure and fair balance requirements. Examples of guidance documents for digital and social media platforms include direction on internet and social media promotion with character space limitations, content on social media posts and stories, and content in influencer marketing. The rapidly evolving digital landscape requires ongoing OPDP awareness and policy refinement.

The future of OPDP involves continued emphasis on consumer behavior research, digital promotion oversight, and adapting regulatory frameworks for emerging technologies such as artificial intelligence. As the pharmaceutical industry continues to evolve and innovate, OPDP will continue to have a crucial role in ensuring that promotional communications are supported by informed decision-making. 

References:

1. FDA. The Office of Prescription Drug Promotion (OPDP). 2024.
2. FDA. OPDP Frequently Asked Questions (FAQs). 2024.
3. Kalola AS, Dean R. The United States Food and Drug Administration and Prescription Drug Promotion. J Innov Card Rhythm Manag. 2019;10(3):3588-3591.

*Information presented on RxTeach does not represent the opinion of any specific company, organization, or team other than the authors themselves. No patient-provider relationship is created.