The Office of Prescription Drug Promotion (OPDP) is reorganizing its two primary advertising review divisions – professional and consumer – in an attempt to stay in line with the silo-breaking, multi-channel promotional output pouring in from pharma.
The line between physician marketing and consumer marketing has blurred as the facets of a brand campaign – from disease and drug-mechanism education to efficacy, safety and lifestyle claims – dovetail across the traditional physician-patient separation.
“We know that DTC advertising is often the catalyst for patients initiating conversations with their physicians about their untreated or undertreated conditions,” wrote Janet Woodcock, director of the Center for Drug Evaluation and Research, in an email on the changes. “The decision to restructure the divisions reflects our commitment to continue providing close oversight of DTC advertising.”
Before it got upgraded to a “Super Office” in 2011, OPDP was fondly (or sometimes not so fondly) called DDMAC (dee dee mac), which stood for the Division of Drug Marketing, Advertising and Communications. When DDMAC turned into OPDP, the office was split into two divisions: the Division of Consumer Drug Promotion, and the Division of Professional Drug Promotion. As OPDP, the steady stream of warning and untitled letters continued unabated, mostly chastising pharma marketers for misbranding, off-label, overstating the efficacy or minimizing the risks of a product, or the misuse of a color scheme, in one famous educational piece created for Novartis.
With today’s announcement, ODPD, pending final review, will rename its two primary divisions. They will now be called the Division of Advertising and Promotion Review I, and the Division of Advertising and Promotion Review II. Review of promotional materials will be separated and organized by therapeutic class, not by professional or consumer. “ODPP concluded that a structure that integrates the review of health care professional-directed and consumer directed promotion across the two divisions” would meet the stated goals of increasing efficiency, improving work distribution, and eliminating redundancy, wrote Woodcock.
“Our ODPD reviewers will continue to use a comprehensive surveillance, enforcement, and education program to foster superior communication of labeling and promotional information to both health care professionals and consumers,” she wrote.
Tom Abrams remains head of ODPD. For a list of the new review groups categorized by therapeutic area, click here.