Class Labeling: Implications for Treatment and Challenges to Differentiation in Development

Submitted by Co-Chairs: Steven Potkin, Steven Romano

Over the last decade, a number of safety issues regarding medicines used to treat neurological and psychiatric conditions have led to class labeling for events such as suicidality (antidepressants, AEDs), metabolic disturbances (atypical antipsychotics) and CV/stroke (atypical antipsychotics in elderly patients with dementia). This has created challenges for clinicians who must make important choices about individual treatment, often without the necessary skills to assess risk at the patient level. Given that the communication of risk in labeling is evolving, the utility of the information currently provided may not necessarily meet the needs of the prescriber. This session will review the evidentiary standards that contribute to the determination of a class label. Specific questions to be addressed include what, in fact, makes a “class” a “class” (shared mechanism? shared targeted indication?); what determines that a product group will have such labeling; and what are the implications for practice, in particular, physician decision-making regarding choosing the right medicine for an individual patient. Current standards for safety capture in phase 2/3 development programs, as well as conventions for safety data display and descriptions in labeling, will be reviewed. Regulatory agency representatives from the United States and the European Union will present regulatory views, addressing evidence requirements and any concerns regarding implications for prescribers and patients. Agency representatives will additionally be asked to highlight any potential future approaches to the display or communication of safety information that could lead to enhanced utility to the prescriber. Emphasis will be placed, during facilitated discussions, on how individual product data might be provided for a specific safety parameter, even in light of that medicine having a class label for that particular safety parameter (for instance, if evidence for class labeling came from pooled/meta-analyses, could a single product’s data be provided in label even in light of “lack of individual signal”). Implications for drug development will be discussed.