FDA Releases Guidance on Risk in Ads

May 26, 2009

Pharmaceutical companies no longer have an excuse if they receive a warning letter from the feds citing them for failure to present balanced risk and benefit information in ads. On Tuesday, FDA released draft guidance highlighting exactly what kind of risk information it is looking for in pharmaceutical and medical device advertising. From the size of the font used in television commercials to the amount of white space in text advertising, the agency detail exactly what it approves or disapproves in drug and device marketing material.

In effect, pharma and device ads must avoid any false or misleading claims, reveal all facts both positive and negative regarding the drug being advertised, and depict information about the benefits and risks in an equal manner. FDA also made it clear that it doesn’t approve of fast-moving imagery or loud music that can distract consumers from absorbing risk and benefit information.

According to the guidance, all ads will be reviewed based on the perspective of the “reasonable consumer,” a standard accepted by the Federal Trade Commission for consumer advertising. It states: “We examine the practice from the perspective of a consumer acting responsibly in the circumstances. If the representation or practice affects or is directed primarily to a particular group, the Commission examines reasonableness from the perspective of the group.”

The guidance even goes into specific details about signals or font size and headlines. For example, pharma companies cannot place risk information in a smaller font size than benefit information, or display it below a benefit statement. The same guidelines go for spoken language, with particular emphasis placed on language used and vagueness of statements.

Placement of risk information is also described at length. FDA recommends that side effects be mentioned at the beginning or end of television or radio ads to maximize recall, while risk info should be placed at the top of print ads, as people are less likely to read something at the end.

In an email to Pharm Exec, FDA spokesperson Karen Mahoney stated that the draft guidance does not change any of the rules that have previously applied to prescription drug and device promotion (guidance documents are intended to describe FDA's current thinking on a topic, rather than introducing new regulatory requirements). FDA's rules and the basis for its enforcement actions remain the same—the Appendix to the guidance describes the applicable legal provisions in detail.  

“What this guidance document provides is an in-depth look at the factors FDA considers when it evaluates promotion for compliance with these longstanding rules and regulations, along with recommendations on effective communication techniques,” Mahoney wrote. “Our aim is to aid companies in effectively communicating risk information in their promotion.”

The guidance is subject to comment for 90 days before being approved or altered.