The Advertising Coalition recently sent comments to the Food and Drug Administration (FDA) in response to a Notice of Proposed Rulemaking (NPRM) regarding “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in Television and Radio Advertisements In a Clear, Conspicuous and Neutral Manner.”
In their letter, the Coalition noted their “vital interest in assuring that the final outcome of this rulemaking protects the public health while at the same time retaining the ongoing viability of DTC television and radio advertising, which itself demonstrably advances that paramount objective.”
Accordingly, the Coalition focused its comments primarily on the so-called “neutrality” criterion that was incorporated by Congress into Section 502(n) of the Federal Food, Drug, and Cosmetic Act, as part of the recently-enacted Food and Drug Administration Act Amendments of 2007. The new criteria now provides that “[i]n the case of an advertisement for a [prescription] drug . . . presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner.”
Specifically, the Coalition asserts that instead of using the so called “neutrality” criterion, the FDA should instead use the concept that the major statement of risk should neither under warn nor over deter or “NUNO” for short.
The Coalition noted that a problem with these criteria is that FDA itself acknowledges that it “. . . is not aware of any previous standards or regulations concerning the definition of ‘neutral manner’ in the context of required disclosures.” In fact, the best the agency can do is to say that “neutral” means “unbiased manner.” Confusing matters further, FDA suggests that “unbiased manner” somehow has to do with avoiding distracting representations (including statements, text, images, or sounds or any combination thereof) when the major statement is being communicated, even though they provide no “meaningful linguistic or other analysis whatsoever.”
This approach is also misguided because to support this criteria, FDA is using results of a concluded study on the impact of distraction on consumer understanding of risks and benefits, which it is still “in the process of analyzing.” Moreover, there are “further empirical studies” that have not been carried out yet that FDA does not know the results of, which is important because they “may provide helpful information for the agency to consider in determining whether a major statement is presented in a ‘neutral’ manner.” Instead, FDA proposes that it “ . . . will provide an opportunity for public comment on the results of the analyses either during the existing comment period or through reopening the comment period if necessary.”
How can FDA assert the need for such criteria when the agency itself acknowledges that even if “neutrality” has to do with distraction, there is an insufficient empirical basis to support any meaningful proposed definition at this time? The Coalition answers this question by stating that in their view, “neutrality” as used in amended Section
502(n) of the Act has nothing whatsoever to do with “distraction.” Rather, the Coalition sees “distraction” as relevant to “clarity” and “conspicuousness” of the major statement, not its “neutrality.”
While the Coalition feel that a major statement is not “clear and conspicuous” if there are “distracting representations … that detract from” the net impression of the communication, they assert that “Congress intended to incorporate a far different meaning of major statement “neutrality” into the statute.”
For example, during deliberations of the new “clear, conspicuous, and neutral” major statement requirement in Section 502(n), Congress had the opportunity to require that the “major statement” of risk be totally devoid of any potentially distracting information by mandating that it be in a black and white “tombstone” format. Consequently, no such action was taken, and the failure to adopt this concept “suggests that “neutrality” has a meaning separate and distinct from anything related to “distraction.”
The Coalition sees “neutral” when used in Section 502(n) having “a qualitative meaning that is quite clearly differentiable from the more objective standards, including “distraction,” for determining when a major statement is “clear and conspicuous.”” In fact, they point Black’s Law Dictionary to define “neutral” and show how its definition “is consistent with their view that “neutral” in this context should relate to the content or substance of an advertisement, not the style or manner in which the content is presented.”
As a result, the Coalition maintains that “a major statement of risk in a DTC television or radio advertisement is qualitatively “neutral” if it neither under warns consumers about the major risks that may result from use of the advertised medicine nor over deters them from using a beneficial product.” This concept that the major statement of risk should neither under warn nor over deter can be called “NUNO” for short.
Underlying this concept is the fact that FDA approved the drug based on a balancing of risks against benefits, and a DTC television or radio advertisement that overemphasizes risks is as potentially misleading as one that overemphasizes benefits. And FDA has acknowledged the soundness of this very principle in its recent Draft Risk Disclosure Guidance, where it said that:
“Effectively disclosing risk information also requires consideration of whether an advertisement or promotional material over warns.”
FDA has also recognized unequivocally in the Preamble to its final rule on prescription drug labeling, that:
“Exaggeration of risk could discourage appropriate use of a beneficial drug.”
Clearly then, as the Coalition comments, FDA should be using the NUNO principal as an operative standard for evaluating the “neutrality” of a major statement of risk, and should only evaluate “distraction” on whether the net impression of a major statement is “clear and conspicuous.” The Coalition also noted that incorporating the NUNO standard into determining when a major statement is “neutral” is perfectly congruent with the existing “fair balance” rules. In fact, in using the “comparability” criterion to “balance” between risks and benefits, the major statement requirement, and the rules on “adequate provision,” the “fair balance” standard is adequately met in the context of DTC television and radio advertising.
Another issue the Coalition addresses is the attempt to incorporate into “major statement” concepts such as comparative safety and effectiveness versus other pharmacologic and non-pharmacologic approaches to treatment, including lifestyle modifications. The Coalition asserts that “to do so would require Congressional amendment, which “almost inevitably would force advertisers—and FDA—to take a non-“neutral” position in complex medical debates, just what the “neutrality” concept put forward by Congress militates against.”
This presents a significant problem for the Coalition because “the law simply does not contemplate safety and effectiveness comparisons of this kind as an element of a “brief summary” nor, consequently, of the “major statement” in DTC television and radio advertising. As a result, the Coalition recognizes that FDA needs proof of such research before making such assertions, especially considering the current “robust debate” regarding comparative effectiveness research.
Conclusion
From their analysis, the Coalition asserts that FDA’s NPRM “fails to acknowledge or even to address the value of DTC advertising in any meaningful way,” and does not “endeavor to put the mandatory disclosure into any type of positive context.” For the Coalition, this is troublesome considering a Draft Risk Disclosure Guidance from FDA in May 2009 stated that FDA must “not just look at specific risk-related statements, but at the net impression—i.e., the message communicated by all elements of the piece as a whole.” This kind of language—from FDA—clearly supports the NUNO principle, which the Coalition advocates.
In the end, “it does no one any good needlessly to frighten consumers away from using the advertised product with a major statement that effectively amounts to a skull and crossbones warning.” As such, FDA should consider the Coalition’s comments seriously, and evaluate the use of the NUNO principle.