FDA seeks balance between flexibility and adequacy in proposed drug risk standards for broadcast DTC ads

The US FDA is proposing standards for determining whether side-effect related statements in direct-to-consumer (DTC) TV and radio advertisements are presented in a "clear, conspicuous and neutral manner". The agency was instructed to do so by a provision of the FDA Amendments Act of 2007. It says that its proposed guidelines provide "flexibility" for drug sponsors to be creative in how they meet the four criteria set forth in a newly proposed rule, and it also seeks comments from industry.

Some industry observers say that the proposed rule leaves plenty of room for interpretation and there may be problems further down the road that could lead to greater enforcement action, at a time when FDA Commissioner Margaret Hamburg has already heightened the focus on enforcement. To others, the proposed rule does not appear to change much in how the FDA evaluates DTC ads.

The FDA Amendments Act of 2007 requires the disclosure of a product's major side-effects and contraindications – otherwise known as the "major statement" – be made in a clear, conspicuous and neutral manner. To satisfy certain provisions of the Act, and in a proposed rule to amend the DTC regulations in the 29 March Federal Register, the FDA offers four criteria for determining when a major statement meets that standard:

* The information is presented in a manner that is readily understandable by consumers;

* The audio part of the information is understandable in terms of volume, articulation, and pacing used;

* The textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a manner that can be read easily (eg, in terms of size and style of font); and

* There are no distracting representations, such as statements, text, images, sounds or any combination thereof, that detract from the communication of the major statement.

In its notice, the agency stated: "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." Sponsors can be creative in designing their ads as long as the "overall message" to consumers – including the major statement – is accurate and not misleading.

One difference is the use of the term "neutral", which has not been used in previous regulations in the context of required disclosures. "We specifically request any comments on standards to establish 'neutral'," the agency said in its notice. The FDA also said it is interested in comments about whether the final rule should require major statements in TV ads to be presented in both the audio and visual parts of advertisements. Comments can be submitted until 28 June.

The FDA said that the proposed regulation is consistent with the factors described in draft guidance issued last May about presentation of risk information in prescription drug and medical device promotion, where the agency emphasised how it frowned on distracting visuals and where it first outlined the concept of an understanding of risks by a "reasonable consumer", where an ad would use everyday words or terms that such a consumer would understand (scripnews.com, 28 May 2009).

According to the FDALawBlog of Hyman, Phelps & McNamara, there are problems with both the new proposal and the draft guidance since they "fail to clearly articulate what type of language will be clear, conspicuous, and neutral to consumers". It goes on to state: "The draft guidance was the first time the 'reasonable consumer' standard had been proposed as a basis for judging the presentation of risk information in DTC promotion. The proposed regulations state that information presented must be 'readily understandable by consumers'. 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 acknowledgement that certain risk information simply cannot be clearly described in supposed 'consumer friendly' language."

Regulatory affairs professionals may be inclined to review carefully one section of the 29 March Federal Register notice. Under "Baseline Practice", the agency said that it had to develop an estimate of the percentage of major statements that would be in violation of the proposed rule. It said that the agency's division of drug marketing, advertising and communications (DDMAC) examined a randomly selected sample of 35 TV and radio drug ads disseminated in 2008 and found that one third could be judged in violation of a clear, conspicuous and neutral standard. "Such results clearly suggest that current regulatory and statutory requirements have not adequately prevented the broadcast of a significant number of potentially misleading or deceptive discussions of product risk," the agency stated.