OPDP Reorg, Outreach Efforts Designed to Improve Relationship with Industry

June 13, 2022 – From a staff reorganization to a monthly newsletter to increased collaborations with stakeholders, in 2022 the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) – under the direction of Dr. Catherine “Katie” Gray – has made a series of organizational and communications moves to make OPDP both more transparent and user-friendly.

New OPDP division

The FDA announced in the Jan. 3 Federal Register a restructuring that adds a third OPDP division: the Division of Promotion Policy, Research and Operations (DPPRO). DPPRO will allow staff to better organize and align efforts as they pursue a research and policy development pipeline in order to “address and investigate issues critical to stakeholders in the field of prescription drug promotion,” Gray stated in her April 2022 column.

“FDA is a science-based organization,” she noted. “This reorganization and OPDP’s long-established social science program underscore that science is a guiding principle for OPDP.”

Led by DDPRO Director Katie David, this third division comprises guidance and policy development, as well as legal, research and project management activities, which should enhance the office’s ability to navigate the rapidly evolving landscape of prescription drug promotion.

“We’re pleased to see the additional prominence for the strong social science research program, which can drive improvements in guiding promotion, especially in such areas as use of social media and statements about adverse effects,” remarked Coalition for Healthcare Communication Executive Director Jon Bigelow.

OPDP “Brief Summary”

In January, OPDP also launched “The Brief Summary” monthly newsletter, dubbed “a one-stop hub for brief updates and newsy notes about OPDP staff and activities,” according to Gray, who also noted in the newsletter’s inaugural issue that it will “serve as another tool to help realize [OPDP’s] noble mission, enhancing communication with OPDP’s stakeholders.”

In addition to providing information on electronic submissions, best practices for interacting with OPDP, core launch updates, enforcement actions and Federal Register updates, the newsletter includes helpful and informative features, such as:

  • A “Gray Matters” column from Gray
  • “Getting to Know OPDP”
  • “Staff Spotlight”
  • “What’s New”

You can view past issues here and sign up for OPDP email updates here.

OPDP/Duke-Margolis collaboration

Late last year, OPDP hosted its first collaborative meeting with the Duke-Margolis Center for Health Policy at Duke University. “The meeting explored potential implications for prescription drug promotion as patients and healthcare providers increasingly use digital tools to inform and manage aspects of care, and drug manufacturers look to these tools to reach target audiences,” according to Gray.

“Much of the discussion focused on identifying touchpoints where researchers both within and outside FDA can focus their attention in order to improve and safeguard the information that makes its way to patients and healthcare providers,” she stated.

The Nov. 19, 2021, public meeting, which brought together experts who have researched prescription drug promotion and digital marketing, discussed:

  • Current research topics
  • Emerging trends in prescription drug promotion and research gaps; and
  • Future research needs.

“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,” a recent report on the meeting stated.

All of these changes help OPDP to move forward in a more proactive manner. “Dr. Gray’s initiatives, such as the reorganization, the conferences with the Duke-Margolis Center, and the introduction of The Brief Summary, show a real focus on making the OPDP’s activities more visible, more efficient, and more user-friendly for stakeholders,” noted CHC’s Bigelow.