The FDA said side-effect related statements in consumer drug ads should be presented in a clear, conspicuous and neutral manner and, in a proposed rule issued this week, allowed for flexibility in determining whether these criteria are met.

The proposal, which appeared in the March 29 Federal Register, would require prescription drug ads to present information about side effects and contraindications in a “clear, conspicuous and neutral” way, and in a manner comparable to any statements about efficacy. This standard would apply when such information is presented in either the audio or visual parts of an ad.

The FDA Amendments Act of 2007 (FDAAA) requires that the disclosure of risks, contraindications and effectiveness made in TV and radio ads—otherwise known as the “major statement”—be made in a clear, conspicuous and neutral manner. In this week’s proposal, the FDA offers four criteria for determining whether a major statement meets that standard:

1. Information is presented in language that is readily understandable by consumers;

2. Audio information is understandable in terms of the volume, articulation and pacing used;

3. Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and font style that can be read easily; and

4. There are no distractions—such as statements, text, images or sounds—that detract from the communication of the major statement.

The FDA said there is no set formula for applying the criteria, saying manufacturers must apply their own judgment for creating major statements: “FDA intends to be flexible enough to consider the variety of techniques sponsors may use to appropriately convey required risk information in prescription drug ads.”

The FDA also said that the proposed regulation is consistent with the factors described in draft guidance issued last May about presentation of risk information—“Presenting Risk Information in Prescription Drug and Medical Device Promotion.” This draft guidance had proposed using a “Reasonable Consumer” standard as a basis for judging the major statement, including use of everyday words or terms that consumers can understand.

Some took exception with both the proposal and draft guidance. “The proposed regulations state that information presented must be ‘readily understandable by consumers,’” noted “However, both the draft guidance and the proposed regulations fail to further articulate ‘who’ these consumers are and what education level they might have.  Nor is there any acknowledgment that certain risk information simply cannot be clearly described in supposed ‘consumer-friendly’ language.” 

Minimizing the major statement in consumer ads, or omitting certain information, has been a source of trouble for drug firms. New FDA Commissioner Margaret Hamburg has heightened the focus on enforcement, and the volume of enforcement letters concerning advertising is up. The Division of Drug Marketing, Advertising and Communication, which reviews DTC and professional prescription-drug promotion, issued 12 letters in January alone.

FDA said manufacturers can be creative in designing their ads, as long as all of the standards listed in the proposed rule are met. That is, the major statement must be communicated “effectively” to consumers and the overall message that the ad—including the major statement—conveys to consumers must be “accurate and non-misleading.”

The agency is accepting written or electronic comments on the proposed rule until June 28.