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Towards a Rational FDA Policy Addressing the Internet and Social Media

Arnold Friede, Counsel to the law firm McDermott Will & Emery LLP, talks about organizing a collective response from representatives of the pharma industry to FDA's recent enforcement initiative on the use of sponsored links in search ads and more generally, on FDA's overall approach to regulating social media and the Internet.

• Guest: Arnold I. Friede, Counsel to the law firm McDermott Will & Emery LLP
• Live Streaming Audio Date: Tuesday, May 26, 2009, 2 PM Eastern US time.
• Live Streaming Audio Duration: 15-20 minutes
  
  
• Go to this Pharma Marketing Talk Segment Page at the time indicated above to listen to the LIVE show via streaming audio on the Web. You will also be able to participate in an online chat with the host and speakers to ask questions!

Background
On April 2, 2009, the FDA issued 14 letters informing drug companies that their search engine ads, which included drug brand names and indications but no risk information or fair balance, were in violation of the law. This caught many in the drug industry by surprise because they assumed the "one-click rule" applies; ie, as long as the fair balance information was just one click away -- on another Web page -- such ads are allowed by the FDA. With the 14 letters, FDA disagreed and quashed the "one-click rule."

Friede believes that there is an opportunity now to make a strong and compelling argument for the adoption of rational regulatory policies by FDA that address the unique features not only of sponsored links, but of other kinds of new communication tools, such as social media and the like. According to Friede (as quoted in Eye On FDA Blog): "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)."

On Tuesday, May 12, 2009, Friede and Bob Nicholas of the law firm McDermott, Will & Emery, convened a video conference to discuss organizing a collective response to FDA's enforcement initiative on the use of sponsored links in prescription drug advertising, and, more generally, on FDA's overall approach to regulating the internet as a distinct medium of communication. See below for some background on FDA's enforcement initiative.

The meeting was open to representatives from pharmaceutical companies, advertising agencies, internet media companies, trade associations and their individual member companies, and others who have a legitimate interest in the evolution of a responsible FDA approach to internet communication. The meeting, however, was not open to the trade press and other members of the media. This podast will present some insights from that meeting and an update regarding progress towards organizing a collective respons eto the FDA.

Some Questions/Topics to be Discussed

• Explain your view of the legal issues raised by FDA's recent enforcement action
• What sort of collective response do you hope to organize and why is it necessary?
• Have you gotten a good response? What's next?

Guest Bio

Arnold I. Friede is counsel to the law firm of McDermott Will & Emery LLP based in its Washington, D.C. office. Arnie is a member of the Firm's Health Law Department. Arnold I. Friede is a widely respected food and drug law counselor and advocate with significant advertising law, health care law, First Amendment, environmental, and commercial and transactional experience. He has a long history of direct involvement in successfully representing clients in FDA-regulated matters beginning as an Associate Chief Counsel in the FDA Chief Counsel's Office, as well as a broad spectrum of senior in-house legal experience across multiple FDA-regulated industries.

Additional Resources

• The 14 Letters. Who at the FDA Knew What and When? FDA Intern Wants to Know!
• A Conversation Around the Legal Questions About the FDA's 14 Untitled Letters on Paid Search Ads