The FDA, Freedom of Speech and the Web

FDA graphicBy Guy Mastrion

For Pharma marketers, digital media (the web specifically) is anything but black and white.

The FDA requires that all branded marketing and promotional materials be viewed within the context of the approved label. For brands and the consumers they serve this means indication, claims and the requisite fair balance.

As marketing partners we understand the rules and we work closely with our clients and their internal medical and legal review teams to assure that we are in compliance with FDA guidelines.

As any one who has ever cut and pasted something from the web can tell you, its pretty easy to take things out of context and place them somewhere else.

As citizens and as consumers of digital media, we have certain rights of freedom of speech and thought. So, lets say a person living with diabetes sees an ad for a diabetes product, and is compelled to copy the ad from whatever website they happen to be on. Then she notices a bit of copy from another source, it could be poetry, that perfectly supports her idea or feelings, so she copies that and then posts it to a site of her own or a social media site. This information, now taken out of context, is an expression of her freedom of speech but it also flies in the face of FDA guidelines. A particularly insightful creation, it spreads very rapidly across the digital space and in essence and fact spreads misleading information. But to her, this bit of compilation represents the truth of her emotions.

Who is responsible? The openness of the web and the ability to create, share and spread free thought is its most enduring legacy and one of its most powerful qualities. Will pharmaceutical advertising bring it down, or will a less severe solution come to the fore?

Pharma companies hire their agency partners who in-turn hire sub-contractors, like photographers, in the context of work for hire agreements. Work for hire transfers authorship and in some instance full ownership of these works to the client. These works often live on for years, protected to a lesser and lesser degree it would seem by copyright and trademark laws.

The client now owns these works, but on the web they are not really protected from use and abuse as noted above.

Recently a client asked us to remove work that we created for them from our corporate and personal websites. The reason for the request, as understood by us, was out of concern that the work could be viewed out of context and not in compliance with FDA guidelines. The client felt at risk for being cited for non-compliance and possibly even fined.

As an agency, our ability to attract new clients requires us to be able to promote ourselves, and prospective clients expect to see case studies of work done for others. Our website and other areas of web presence provide unique opportunities to showcase our work. To display one page of concept and often two or three pages of fair balance in the context of self-promotion to the trade seems unreasonable.

Even our employees, many of them creative professionals rely on the showcasing of work to advance their careers. The Web has replaced the traditional portfolio as a means of sharing work with a prospective employer, just as it has for agencies to showoff their wares.

Somehow I dont think the FDA had any of this in mind when it set forth its guidance to Pharma. And the facts are that for years, agencies, their creative staff, art directors, writers, photographers, illustrators, etc. have been showing work to prospects in portfolios and reels with little concern for including the fair balance.

Enter the Web with its limitless reach and manipulation capabilities and suddenly were playing, if not by a new set of rules, a more strict and more easily enforced compliance.

As professionals we dont intend to break the rules for the purpose of spreading misinformation. After all why bite the hand that feeds you? We only wish to showcase our talents in the best light, and that does not always allow or warrant the work being shown in full context of its label. We need the ability to promote ourselves, to maintain some ownership of the work; otherwise were out of business. I believe as professionals and the creators of the ideas we have certain rights, including the right to work. Earning a living through our talents and the promotion of our capabilities as demonstrated by work done for others should be a respected and supported part of our rights.

Executing work for hire, without some latitude from our clients and a more relaxed attitude from the FDA or a clear statement of allowable use for this situation, would have agencies, no longer able to promote their talents.

And what of the small independent artist, subcontractors to agencies and media companies? Are we obligated to tell them that they can no longer promote themselves unless the work is seen in context of the drug label?

Lets come back to the rights of the individual citizen, cobbling together some crafty expression of their experience as a diabetic. Will the FDA send them a warning letter and fly in the face of constitutional law? Will Pharma companies start pursuing individual citizens for trademark and copyright infringement and risk alienating a customer group?

We have in our midst the confluence of contract law, intellectual property law and constitutional law.

Who is responsible for navigating these oft-conflicting laws? Who will interpret the rights of the individual citizen-creator in the digital age?

How should this be governed, and by who? Should it be governed at all?

Whos rights will be protected and whos will be lost?

What do you think?

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4 Responses to The FDA, Freedom of Speech and the Web

  1. Pingback: Pharma, Freedom of Speech, and Ad Agencies | Pharma Marketer

  2. admin says:

    FOR IMMEDIATE RELEASE

    Communications and Regulatory Experts Outline Best Practices for
    Compliant Data Dissemination in the New Era of FDA

    NEW YORK, September 11, 2009 Public relations and regulatory compliance experts will outline best practices for sharing data with media and advocacy groups, and responding to external queries, at the 2009 Regulatory Affairs Professionals Society (RAPS) annual conference in Philadelphia. The discussion is timely given the recent announcement by newly appointed FDA Commissioner, Dr. Margaret Hamburg, that the Agency is laying a new foundation for enforcement that makes regulatory compliance a priority at every stage of drug development from pre-approval to post-marketing.

    The external communications environment is complex and fast moving. “Media are looking for high-impact stories, social media continues to be uncharted regulatory territory, and multiple audiences are operating across a variety of media outlets, says Barbara Box, New York and Chicago Healthcare President, Weber Shandwick. “In the new era of FDA, we all have a responsibility to align ourselves around compliant strategies for data dissemination.

    Ilyssa Levins, President of the Center for Communication Compliance (CCC), outlines four steps to achieve alignment between public relations and regulatory professionals:

    Commit to teamwork
    Make a culture of compliance a priority
    Get everyone on the same regulatory baseline through training and certification, and
    Implement best practices in compliance.

    “In this way, everyone achieves their objectives without running afoul of regulations, she states.

    Lucy Rose, regulatory expert and former FDA official, agrees: “In this environment, a team regulatory approach leads to a better functioning operation more productive meetings and program ideas that see the light of day. Rose is president of Lucy Rose and Associates.

    The panel discussion, which will take place on September 15th, 2009 at 8:30 am at the Philadelphia Convention Center, is moderated by Peter Carson, EVP, Healthcare Public Affairs, Powell Tate. Panelists will include Barbara Box, Lucy Rose, Sheryl Williams, VP, Public Affairs, Cephalon, and Ilyssa Levins.
    # # #

    Ǭ∑ For more information on RAPS, please visit http://www.RAPS.com < http://www.RAPS.com> < http://www.RAPS.com>

    Ilyssa Levins, President
    Center for Communication Compliance (CCC)
    ilevins@communicationcompliance.com
    p: 212-361-9868, f:212-980-3760
    303 E 57th Street, Suite 21B, NY, NY 10022
    http://www.CommunicationCompliance.com < http://www.CommunicationCompliance.com>