Commissioner Margaret Hamburg, M.D.
Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
These comments from Public Citizen Health Research Group come in response to Docket No. FDA-2009-N-0582, the FDA Proposed Rule relating to Direct-to-Consumer (DTC) Drug Advertisements, published at 75 FR 15376, March 29, 2010.
It is important to note that well over a decade ago, the FDA considered and even drafted regulations concerning DTC advertising, based on the correct notion that the target audience, consumers, has a very different background in matters pertaining to drug safety and effectiveness than doctors, pharmacists and nurses, the primary intended audience for the then and currently existing advertising regulations. For reasons that were never made clear, these draft regulations never saw the light of day and it would be important to see them in the context of this new, belated rulemaking effort. This disclosure is particularly important since it is highly likely, if not certain, that the scope of the draft rule from the 1990’s was far broader than the relatively narrow area of DTC advertising covered by the current proposed rule.
Public Citizen does not support DTC advertising of pharmaceutical products on broadcast media. The United States is one of two countries in the world that permit it (the other being New Zealand), and Public Citizen believes that DTC advertising has not advanced public health in either country. (See Lurie P, DTC Advertising Harms Patients and Should be Tightly Regulated, J Law Med Ethics 2009; 37:444-450.)
Given that DTC advertising via broadcast media is permitted in the United States at this time, ostensibly as protected commercial speech, and while reserving our objections thereto, Public Citizen agrees with the general proposition that such advertising should include “major statements” of risk, including side-effects and contraindications in a clear, convincing and neutral manner. This is particularly important as a public safety matter in light of the limited time most physicians have in which to fully advise patients regarding harmful side effects.
Public Citizen suggests that whether a particular advertisement presents risks in a “clear, convincing and neutral” manner should be determined by techniques similar to those used to determine consumer comprehension of benefits.
By requiring that the major statement of risks be presented in a clear, convincing and neutral manner, Congress intended that consumers be given adequate information to comprehend risks equally with the benefits of a particular drug. It therefore seems reasonable to require that the same marketing techniques be used in presenting these risks as are used in presenting the benefits.
To assure that target consumers might equally comprehend risks and benefits of an advertised product, Public Citizen proposes that requests for approval of each proposed “direct to consumer” media advertisement be supported by the results of independent market research organizations. Market research organizations are equipped to carry out empirical testing to determine the extent to which the benefits of advertised products are understood by target consumers. The same techniques should be used to determine the extent to which statements of risk (including side effects and contraindications) are comprehended by the same target group. Applicants should be required to demonstrate that the consumer testing was bias-free in that it was not rigged to inaccurately alter the perceptions and/or comprehension of benefit or risk by the target group.
FDA has specifically requested guidance as to whether the practice of the Federal Trade Commission (FTC) should be adopted in requiring simultaneous video presentation of required audio messages, and as to how the word “neutral” should be interpreted in setting forth information contained in the “major statement” in a “clear, convincing and neutral” manner. The remainder of this comment will focus on these questions.
1. Should the practice of the FTC be adopted to require simultaneous video presentation of required audio messages?
YES. Besides noting the adoption of this practice elsewhere, notably by the FTC, FDA has cited literature supporting the proposition that increased comprehension results when learners can see information as well as hear it and appropriate visuals could direct the attention of the viewer to the simultaneously spoken message.
DTC advertisements currently seen on television frequently distract the viewer from statements of risk with attractive images, often promoting the benefits but having little or nothing to do with the side effects, contraindications and warnings, etc. The current practice of showing distracting benefits images while lists of side effects, contraindications and warnings, etc., are read in either a monotone or a reassuring tone of voice must not continue.
2. Should a broad definition of neutral (as described below) be adopted so that “neutral” would not be a superfluous term?
YES. As noted in the proposed rule, the 2007 Amendments to the Food Drug and Cosmetic act require that the “major statement” in DTC television and radio advertising relating to side effects and contraindications of an advertised prescription drug intended for humans be presented in a “clear, conspicuous and neutral manner.” FDA has asked for guidance in implementing this Congressional directive of neutrality in presenting information regarding side effects and contraindication, and has indicated that it is not aware of previous standards from other agencies concerning this term. 75 FR 15379 further notes that the terms “clear and conspicuous” have been given extensive interpretations by other agencies but it appears that many of these definitions blur into common definitions of “neutrality.” Therefore, adopting these interpretations alone could render the word “neutral” superfluous.
If “neutral” is to be meaningful, it must encompass features not included in “clear and conspicuous.” We therefore propose a definition of neutrality that would present the advertised product in a “neutral manner” as compared with other pharamacologic or non-pharmacologic approaches to the indications for use, as well as considerations relating to consumer convenience, comfort and cost. Since the desirability of assuming risks (including side effects and contraindications as defined herein) can only be evaluated by comparison with expected benefits, the expected benefits must also be considered in determining “neutrality.”
Public Citizen therefore proposes that to present information “neutrally,” DTC advertising should include the following information:
a. How do the risks of the product compare with the expected benefits of use?
b. How does the product compare in safety and efficacy with existing products – both under patent and generic – for the same indication?
c. How does the product compare in safety and efficacy with non-pharmaceutical approaches (including but not limited to lifestyle modification) for the same indication?
Including this information will result in a more neutral presentation by giving consumers a balanced picture of the benefits and risks of the advertised product.
In summary, Public Citizen suggests the following amendments to the proposed rule.
1. To obtain approval of DTC advertising on broadcast media, a party shall present market research demonstrating that information concerning side effects, contraindications and warnings is comprehensible to the target audience, using market research equivalent to that carried out with respect to the benefits of that product.
2. DTC advertising on television and other audio-visual media shall present appropriate visual information about side effects, contraindications and warnings simultaneously with the audio presentation.
3. A broad definition of “neutral” should be adopted to require presentation of other approaches, both pharmacologic and non-pharmacologic, to treating the target condition.
Sidney M. Wolfe, M.D.
Public Citizen’s Health Research Group
Joan Levin, J.D., M.P.H.
Formerly of the Health Research Group