Industry, pharmacists call for changes to FDA labeling guidance

Pharmacists, drug companies, and other stakeholders want FDA to do some more work on its new draft guidance governing the "Indications and Usage" section of product labels. The American Pharmacists Association (APhA), for example, suggests that the regulator step up its surveillance of drugs or biologics with expanded or narrow indications.

Pharmacists, drug companies, and other stakeholders want FDA to do some more work on its new draft guidance governing the "Indications and Usage" section of product labels. The American Pharmacists Association (APhA), for example, suggests that the regulator step up its surveillance of drugs or biologics with expanded or narrow indications. It also believes FDA should carefully monitor adverse events affecting populations that were not studied as well as keep an eye on whether certain patient groups are being disproportionately excluded from labeling. On the matter of "Limitations of Use," meanwhile, APhA had this to say: "Because prominent placement of Limitations of Use in the labeling may infer a greater risk, APhA recommends FDA test whether the labeling is confusing or misleading to health care practitioners." Additional feedback from other industry interests touch on areas such whether or not to include information on secondary outcomes and whether or not age groups should be routinely specified in the "Indications" section, among other comments.