The drugmaker received a warning letter that a professional file card, which is basically promotional material, overestimated the effectiveness of its Alzheimer’s med, contained misleading info concerning risks and unsubstantiated superiority claims, and recommended an unapproved combo with another drug. You can look at the file card here.

“These violations are concerning from a public health perspective because they suggest that Exelon is safer or more effective than has been demonstrated, and they encourage the use of Exelon in circumstances other than those for which the drug has been shown to be safe and effective,” wrote Tom Abrams, who heads the FDA’s Division of Drug Marketing, Advertising and Communications, in the letter to Alex Gorsky, who heads Novartis pharma in the US.

This is the second time in recent days the FDA’s DDMAC has warned a drugmaker over its promotional materials. Pfizer received such a warning for an ad for its Geodon schizophrenia treatment. As the FDA Law Blog notes, DDMAC is concerned with the ’substantial evidence’ notion - promotional pieces contain substantial evidence to support advertising claims and proper presentations of safety data.