FDA issues DTC ad guidelines


The Food and Drug Administration just released proposed guidelines for drug and medical device television ads meant to reduce diversions to consumers. Reuters reported that the agency said such ads should steer clear of images and music that sidetracks viewers from critical information on potential side effects.

See the full draft here

The guidelines suggest that both benefits and risks be explained in similar type styles and voice-overs, said Reuters. The proposed guidelines were prompted by complaints pointing to drug maker tactics to minimize risks and play up benefits via distracting music and type styles, explained Reuters.

From the size of the font used in television commercials to the amount of white space in text advertising, the FTC describes exactly what it approves or disapproves in drug and device marketing material. Pharma 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.

All ads will be reviewed based on the perspective of the “reasonable consumer,” a standard accepted by the Federal Trade Commission for consumer advertising: “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.”

FDA also 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.

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