IMPORTANT NEWS FROM THE PAAB

PAAB Code Clarification – Implementation April 2002

At the November 9, 2001 Board meeting, the PAAB members unanimously approved a revision to the PAAB Code. PAAB Commissioner Ray Chepesiuk presented the following backgrounder to the members. “Currently PAAB Code section 6.6.f allows for exemption from preclearance review for ‘Patient information from product monographs and patient education material’. There are no explanatory notes to accompany that section. Prior to the 1993 Code revision, patient education materials created by pharmaceutical companies and distributed through health professionals did require PAAB preclearance review. It may have been believed that the ‘information for the Consumer’ section of the Product Monograph would be distributed by drug companies and those items would not require PAAB review. The intent of the Information to the Consumer is to provide adequate directions for use of a product to achieve optimal therapeutic results. We have seen a recent proliferation of these items and a rise in the number of complaints regarding violations of the Food & Drugs Act because the items were perceived to be ‘advertising’ and not ‘information’. Sponsors were incorrect in their assessment of the regulatory status of the material. Companies have viewed these items as an opportunity to communicate product-specific messages directly to patients and to the general public. In my opinion, this activity is leading to the perception that this type of item is a loophole in the regulatory framework and may contribute to mistrust of the pharmaceutical industry.”