(Saint Petersburg, FL - July 5, 2011)

The US FDA recently completed a study aimed at discovering whether or not consumers truly comprehend information provided on drug labeling and other printed material. The overall conclusion of the study was that the "brief summary" section on printed materials clearly affects consumer understanding of prescription medications.

FDA regulations require that printed advertisements for prescription drugs must contain a true statement of information "in brief summary" with regards to side effects, contraindications, and effectiveness. Print ads, such as those in magazines and newspapers, are often two or more pages long. The first page is more sales and marketing related and often includes pictures and intended uses. The second page summarizes product risks and often includes considerable technical information.

While this particular FDA study did not conclusively deem changes to industry advertising and labeling are required, the fact that the agency dedicated resources to this effort is indicative that changes to regulations associated with packaging, labeling, and product advertising may be on the way sooner than later.

According to Jonathan Lewis, Principal at Advanced Biomedical Consulting, a leading FDA compliance consulting firm, labeling, advertising, and regulatory affairs are among the most time consuming and costly activities associated with drug manufacturing and marketing. Therefore, conclusions from FDA's studies and recent enforcement trends should be carefully monitored by industry in the coming months to help ensure changes in requirements to not result in non-compliant labeling and advertising efforts.

 (Saint Petersburg, FL - July 5, 2011)