Throughout 2022, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has made efforts to become more transparent and user-friendly.
New Monthly Newsletter
In January 2022, OPDP launched “The Brief Summary,” a “one-stop hub for brief updates and newsy notes about OPDP staff and activities.” In the January issue, OPDP Office Director Dr. Catherine (Katie) Gray noted that the newsletter will “serve as another tool to help realize [OPDP’s] noble mission, enhancing communication with OPDP’s stakeholders.”
The newsletter provides updates on electronic submissions, best practices for interacting with the agency, core launch updates, enforcement actions, and Federal Register updates. Additionally, the newsletter features a “Gray Matters” column from Dr. Gray, a “Getting to Know OPDP” section, a “Staff Spotlight,” and a “What’s New” section.
New OPDP Division
At the start of the year, FDA announced in the Federal Register that it would be adding a third OPDP division: the Division of Promotion Policy, Research and Operations, which would allow staff to better organize and align their efforts in pursuing a research and policy development pipeline. Dr. Gray noted that “FDA is a science-based organization” and that this “reorganization and OPDP’s long-established social science program underscore that…guiding principle.”
The new OPDP vision will be led by Katie David and focus on guidance and policy development, in addition to legal, research, and project management activities. It’s the goal of the new division to help the agency navigate the rapidly evolving landscape of prescription drug promotion.
OPDP/Duke-Margolis Collaboration
In November 2021, OPDP and the Duke-Margolis Center for Health Policy hosted a collaborative meeting, focused on informing and refining the prescription drug promotion research agenda, including implications for prescription drug promotion related to the increase in use of digital tools. Specifically, topics such as the effects of social media and influencer promotion, native advertising, and impacts on vulnerable consumers like adolescents and those with existing health conditions came up, as well as future trends and research areas that could benefit from further study such as changes in promotion to HCPs including the rise of e-detailing. During the collaborative meeting, participants were able to discuss research topics, emerging trends in prescription drug promotion and research gaps, and future research needs.
A Meeting Report noted that, “Overall, as new forms of prescription drug promotion emerge, regulators and the broader research community must work together to better understand how promotional communications in the digital space impact consumers and HCPs and how to best protect public health.”