Banner Ads Need Specific FDA Guidance: Professor

University of Miami professor Crystal Adams says it appears that drug manufacturers using Internet banner ads for prescription drugs are trying to comply with FDA ad guidelines that are not really applicable. In the absence of specific guidelines for banner ads, she writes online in the Journal of Medical Internet Research, companies are trying to comply with regulations intended for print and broadcast media. Adams says that the agency “should formalize requirements that drug companies provide a brief summary and include multiple forms of adequate provision in banner ads.”

Adams’ analysis of 68 banner ads found that each contained a brief summary of risk information and at least one form of adequate provision to give consumers additional information about the drug. She found that there were about 7.18 risk facts for every benefit fact.

“The study supports prior content analyses of prescription drug ads that find that ads largely comply with the adequate provision and major statement broadcast requirements,” the report says. “Although ads did not use a toll-free phone number and print ads as provision, they disclosed other forms of provisions that may be helpful to patients. The banner ads abide by the print ad regulation requiring the inclusion of the MedWatch statement, which may be helpful to the public by informing them of this reporting mechanism. Banner ads did not achieve fair balance in terms of the ratio of risk to benefit facts in the main portion of the ad.”

Adams says that recent FDA guidance on Internet social media does not provide much direction to firms seeking to generate banner ads that comply with regulations. Given the constantly changing nature of the Internet, she says, it is difficult to create guidelines for each specific medium. But she calls on the agency to “continually construct new guidance and revise past guidance so as to provide direction to the agency and identify instances of malfeasance.’