The issuance of the 14 untitled letters by the FDA a week ago Friday has been very troubling on a number of circumstances. The agency accompanied the action that the letters were sent as part of "routine monitoring" which, unfortunately, is not credible given the fact that the practice of search engine advertising has been going on for years.
One may be of the opinion that from a policy point of view, what the FDA has done was an exercise in extremely poor judgment. But what about the legal standing? It seemed like a good idea to talk to a lawyer who wasn't me about the topic. I had the good fortune to speak with Arnold Friede, counsel at the firm of McDermott, Will & Emery. He agreed that there were many questions about the FDA action on both a legal and policy grounds and had interesting perspectives on the nature of search engine advertising.
According to Friede:
Unilateral rejection by DDMAC of the landing page as a component of the entire advertisement effectively misinterprets what is the "advertisement" as a whole. It violates cardinal principles of advertising interpretation that FDA itself has routinely adopted in a variety of related contexts. For example, in its Draft Guidance on Help Seeking Ads, and in its Warning Letter to at least one pharmaceutical company on "bookending" of "reminder" and "help seeking" ads, FDA/DDMAC has quite clearly taken the position that seemingly separate advertisements should nevertheless be considered as a whole in determining whether the ensuing "advertisement" does or does not comply with the requirements for disclosure of "fair balance". Likewise, and by strong analogy, the very definition of "labeling", which is an analogue of the statutorily undefined term "advertising", refers to information "accompanying" the product and not merely what is on the actual label. In this connection, FDA has long taken the position, which has been upheld by the U.S. Supreme Court, that a broad interpretation of what "accompanies" a product is consistent with the statutory definition of the term "labeling" as both a legal matter and a matter of public health policy And there are any number of authorities, from FDA, FTC, and the courts, that overall context determines the meaning of an advertisement, and that in determining that meaning, one looks at the entire mosaic of the advertisement and not at each individual tile. If that principle, which FDA routinely applies, holds in determining the meaning of an "advertisement", it ought to apply similarly in determining what IS "the advertisement" in the first instance.
Viewing the matter from this perspective, FDA's approach of unilaterally rejecting the contents of the landing page as a component of the advertising is unquestionably wrong as a legal matter. It may also violate the First Amendment, which, as the Supreme Court held in Hustler v. Falwell, requires that information (in that case, a parody) be interpreted using a "reasonable man" standard. (Every reasonable person knows that clicking on the sponsored link takes you to additional and contextually integrated information. It's like going beyond the front page of the newspaper to get to the rest of the story Everyone knows you've got to the turn the page, and they tell you as much, as do the hot links here). And the principle that context determines meaning has likewise been applied by the Supreme Court in any number of related contexts (e.g. in the Brown & Williamson case, which involved the scope of FDA's statutory authority).
After recording this podcast, I did get a further explanation from Julie Zawisca at CDER's Public Affairs office. Julie is a great person and an asset at FDA. The podcast referred to here is the one posted here with DDMAC's Dr. Jean Ah Kang.
and the discussion around our podcast was about use of Web 2.0/social
media tools, which we view as tools that are
characterized by interactions between users on the Internet and/or by
being comprised largely of user generated content, rather than about
promotion on the internet generally. We wouldn't characterize
sponsored links as belonging in this 2.0 category, and we also wouldn't
characterize these untitled letters as a message about Web 2.0. Our
participation in the podcast was intended to be a good faith effort to
communicate about those new social media tools, and to reinforce our
standard message that our regulation of promotion is based on the nature of the
message conveyed rather than the medium used to convey it.
Unlike some of the
issues that may come up in the future regarding the use of Web 2.0
tools to promote products, the problems cited in these untitled
letters were not new agency interpretations of a policy or regulatory
issue - in other words, they were not the type of thing that is proper
to address in a guidance.
in the eyeonfda post on this issue after the letters issued:
action against the fourteen companies would have occurred had they been
involved in any other medium. The letters were not issued because of the
use of online media, they were issued because the type of intervention chosen
by the companies was not within regulatory confines. Ads for drugs were
run without any risk information. Period.
We've cited other
pieces on the web and in other media for similar issues for man years. We understand that there is a higher level of
interest in this case because of the number of letters, but we
disagree with the characterization of this as whack-a-mole – that
might be a valid characterization if we had singled out a lone
sponsored link when we had observed that company's competitors engaging in
the same violative behavior, but not here. Our purpose in issuing
multiple letters simultaneously was to maintain a level-playing
I am grateful for the FDA response and technically, they are right on the distinction between Web 1.0 and Web 2.0, but I think that is beside the point somewhat. The response does not address the fact that the practice of the search engine site ads has been going on for many, many years. To suddenly jump on it in one day with 14 letters, is in my mind, not only whack-a-mole but a dramatic example of it.
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
I am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.