The Food and Drug Administration (FDA) is weighing whether it needs to update its rules regarding advertisements for prescription medicine on radio and television, including whether those ads fully and conspicuously disclose all potential side effects that patients might experience.
Under the FDA’s current rules, broadcast advertisements for pharmaceuticals must disclose major side effects in a clear and conspicuous manner, but only as they relate to the conditions that the medicines claim to treat.
Updated rules under consideration at the FDA would require broadcast advertisements to disclose all major side effects, even if they do not directly relate to the condition being treated by a drug. It would also outline various elements of presentation, including setting specific rules about the tone and cadence of voice-over audio.
The FDA says it considers a “clear” notice to include:
- a presentation of information that is in clear, concise sentences, paragraphs and sections;
- one that uses short explanatory sentences or bulleted lists, when possible;
- one that uses definitive, concrete, everyday words and an active voice when possible;
- one that avoids multiple negatives;
- one that avoids highly legal and technical business termination, when possible; and
- one that avoids explanations that are imprecise and readily subject to different interpretations.
Likewise, it considers a notice to be “conspicuous” if:
- it uses plain language to call attention to the notice;
- it uses a typeface and type size that are easy to read;
- it provides wide margins and ample line spacing;
- it uses boldface or italics for certain keywords; and
- it uses distinctive type size, style and graphic devices, including shading or sidebars, when the notice is combined with other information.
“Overall, FDA believes that the standards described previously for clear and conspicuous disclosures provide appropriate information for the agency to use in developing its own standards for evaluating major statements,” the FDA wrote in a bulletin published last month. “Several of the policies and regulations described previously are similar to the ones set forth in this proposed rule in that they apply to consumer comprehension of disclosure information in television and radio advertisements.”
The proposal doesn’t specifically call for any rules regarding volume or articulation on pharma ads that run on television or radio, but said ads that are “inarticulate” could violate the spirit of its rules and be subject to investigation.
The rules would be another enforcement mechanism to ensure pharma ads are offering consumers as much information as possible, and would be in addition to regulations imposed by the Federal Trade Commission (FTC) on over-the-counter medicines that are advertised through broadcast.
Among other things, the FTC requires medicine ads to offer presentation in a “slow and deliberate manner and in a reasonably understandable volume” in order to satisfy that agency’s “clear and conspicuous” rule.
Pharmaceutical companies are among the biggest advertisers on traditional broadcast radio and television, with Pfizer, Merck and other firms spending around $8 billion toward ads last year.