FDA's DDMAC explores "mental models" of prescribers

The US Food and Drug Administration's Division of Drug Marketing, Advertising and Communications has issued a new report titled: Mental  Models Study of Health Care Providers' Understanding of Prescription  Drug Effectiveness. A notice concerning the report appears in the  Federal Register for April 3.

The DDMAC states that "the presentation [in advertisements] of...risk  information is likely to evoke trade offs by consumers and physicians,  ie, comparisons with the perceived risks of not taking a treatment and  comparisons with the perceived benefits of taking a treatment." Because  the FDA is tasked with the fostering of safe and proper use of  prescription drugs, "an in-depth understanding of physicians' processing  of this information, their thinking on relevant topics and their  informational needs are central to this regulatory task."

Peter Pitts, the president of the Center for Medicine in the Public  Interest, a New York-based think-tank specializing in pharmaceutical  issues, welcomes the DDMAC's efforts to ensure that direct-to-consumer  advertising carries the right level of risk awareness to physicians and  patients about adverse effects. However, Mr Pitts also asks: "shouldn't  the DDMAC look first to the well-understood failure of both the brief  summary and fair balance/adequate provision methods it currently uses?"