30 - Can risk data be presented for patients with concomitant risk factors. ie, the product is a statin that is indicated to reduce cholesterol and also CV events in patients with high cholesterol. The registration trial obviously included patients with high cholesterol and other risk factors. Can risk data be presented on patients with hypercholesterolemia and a risk factor within the registration trial?

  • Risk data for patients with concomitant risk factors can be presented in advertising if those data are consistent with what has been approved in the product monograph (PAAB Code s3.1). In the example mentioned in the question, the PAAB would accept claims related to the cardiovascular events that are stated in the product monograph. If the risk factor in the registration file is specifically stated in the product monograph it can be presented in advertising. Just because a study is cited in the bibliography section of the product monograph does not mean the PAAB would accept all data claims from that study. Get your regulatory folks to include all relevant data claims in the product monograph text, not just a listing in the bibliography.