Presenting Risk Information in DTC Ads: FDA Issues Proposed Rule That Allows for Flexibility

March 31, 2010

By Carrie S. Martin & Dara Katcher Levy

On March 29, 2010, FDA published a proposed rule to amend its direct-to-consumer (“DTC”) regulations to require that prescription drug advertisements present information about side effects and contraindications in a “clear, conspicuous, and neutral manner.”  Current regulations, found in 21 C.F.R. 202.1, require the disclosure of major side effects and contraindications (commonly known as the “major statement”) in either the audio or audio and visual parts of an advertisement and that they be presented in a comparable manner to any statements regarding the drug’s efficacy. 

With the passage of the FDA Amendments Act of 2007 (“FDAAA”), Section 502(n) of the Food and Drug Cosmetic Act (“FDC Act”) now requires that the major statement in television and radio advertisements to consumers be presented in a “clear, conspicuous, and neutral manner.”  The Agency looked to standards set by other agencies for guidance, including the Federal Trade Commission (“FTC”), the Department of Treasury (“DOT”), and the Securities and Exchange Commission (“SEC”).  FDA now proposes to amend Section 202.1(e)(1) to include four criteria as to when a major statement would be considered “clear, conspicuous, and neutral”:

(1)  The information is presented in language that is readily understandable by consumers;

(2)  The audio information is understandable in terms of the volume, articulation, and pacing used;

(3)  The textual information is placed appropriately and is presented on a contrasting background for sufficient duration and in a manner that can be read easily (e.g., in terms of size and style of font); and

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

FDA admits that these guidelines provide “flexibility” for drug sponsors to be creative in how they meet these four criteria.  In addition, the Agency believes that these proposed guidelines are consistent with the draft guidance it issued in May 2009 about the presentation of risk information entitled “Presenting Risk Information in Prescription Drug and Medical Device Promotion” ("Draft Guidance"). 

Unfortunately, both the draft guidance and the proposed regulations fail to clearly articulate what type of language will be clear, conspicuous, and neutral to consumers.  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 acknowledgment that certain risk information simply cannot be clearly described in supposed "consumer-friendly" language.  Further, the Agency admits that it was not aware of any previous standard of what constitutes "neutral" in the "context of required disclosures" and asks the public for comments specifically addressing this issue.

Written or electronic comments should be submitted by June 28, 2010.  FDA is particularly interested in comments about whether the final rule should require major statements to be presented in both the audio and visual parts of advertisements, as well as comments about the "neutral" standard.  Written comments can be faxed to the Agency (301-827-6870) or sent to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  Electronic submissions must go through the following website:

Categories: Drug Development