Wednesday, August 05, 2009

DTC Implications: FDA Calls Foul on Magic Johnson Promotional DVD

Written by Arnold I. Friede

Source: The RPM Report
July 2009, Vol. 4, No. 7
(posted with permission of author)

FDA’s criticisms of promotional DVD for Abbott’s Kaletra highlight pitfalls of celebrity testimonials. FDA says too much of the session with the basketball star focuses on benefits from drug; risk information is just an afterthought. The interview with net star also demonstrates FDA concept of inaccurate “net impression.” The DVD creates implied claim that drug works for five years – without supporting data.

On July 14, the Division of Drug Marketing, Advertising, and Communications (DDMAC) in FDA’s Center for Drug Evaluation and Research issued a Warning Letter about a promotional DVD featuring an interview with basketball great Earvin “Magic” Johnson about his personal experience with the combination protease inhibitor AIDS drug, Kaletra (lopinavir and ritonavir).

This compliance correspondence offers immediate insight into how a few of the concepts articulated by the agency in its May 2009 Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion will be applied in practice.

In this context, perhaps the most important aspect of the Warning Letter has to do with the substantial criticism by the agency of where and when in the promotional DVD the key risk information appears.

According to DDMAC, “the first 11[and 1/2] minutes of the promotional DVD are devoted to an engaging and lively discussion…presented in an interview format…that includes a discussion of the benefits Magic Johnson has received from Kaletra.” However, “in contrast, the presentation of serious risks associated with Kaletra is relegated to the end of the DVD after the interview is over, where it is unlikely to draw the viewer’s attention.”

FDA says “this overall presentation misleadingly minimizes the serious risks associated with Kaletra because it fails to convey the important risk information with a prominence and readability reasonably comparable to the claims of effectiveness.”

Putting aside for the moment the underlying concerns about the importance in context of the specific information about the drug’s serious risks, the temporal delay between communication of the benefit information in the promotional DVD and the information about serious risks was in and of itself particularly troublesome to FDA. In this respect, DDMAC appears to be articulating a principle that might be termed “tight integration” of risk with benefit information.

As the agency said in the draft guidance: “In addition to appearing with or near benefit presentations, risk information should appear as an integral part of the piece, just as benefit information does.”

One might question how the principle of “tight integration” might be applied where the temporal delay between the benefit and risk information is substantially less than the 11 and 1/2 minute delay in the Magic Johnson promotional DVD—say, for example in the context of a 60 second television commercial. At the same time, however, deviation from that principle, at least as perceived by DDMAC, is a major aspect of this Warning Letter.

A second key lesson from FDA’s letter has to do with whether, to what extent and how testimonial claims can be generalized to a broader target audience consistent with the “net impression” standard for evaluating the meaning of advertising as articulated in the draft guidance.

Magic Johnson is perhaps the best known example of the role and value of chemotherapeutic management of AIDS through aggressive use of anti-retroviral agents. He is an almost perfect embodiment of how these medicines have helped many people with the disease lead a relatively “normal life”.

We can all recall a time when these drugs were not generally available in the United States, and the ravages of the disease without them. At the same time, FDA has an institutional concern, grounded in the statutory “substantial evidence” standard, about basing promotional claims on one person’s experience, or even the experience of a small group, and then extrapolating from there to a broader population.

In this context , one can certainly comprehend the concern that the “net impression”—although the term is not used explicitly in the letter—from the Magic Johnson interview is the claim that Kaletra would be effective for at least five years and allow someone to lead an absolutely “normal life” except for having to take medication.

This concern was intensified because, ironically, almost precisely five years ago (on October 29, 2004), DDMAC issued an untitled letter about implied claims “that patients taking Kaletra can expect to survive and be healthy for at least five years, in the absence of substantial evidence or substantial clinical experience to support such an implication.”

This overall net impression was not alleviated, according to FDA, by the use in a “super” of the qualifier “individual results may vary”. This interpretation is consistent with the tenor of the draft guidance, which repeatedly emphasizes the limitations of qualifying information in a variety of contexts.

In the end, the draft guidance provides a useful prism for discerning some of the generalizable principles in FDA’s Warning Letter on Kaletra and the Magic Johnson DVD. It should likewise provide a useful framework for both going-forward and retrospective analysis of other DDMAC compliance correspondence.

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