FDA's November meeting to address drug promotion may lead to more clearly defined boundaries across all mediums, not just the Internet, Ted Smith, executive vice president of patient engagement at HealthCentral and a former Obama campaign advisor, noted just after an industry gathering.

Smith, who spoke at a DTC Perspectives conference in Livingston, N.J., on Oct. 14, expects that, after listening to concerns from drug makers and others, FDA will be able to examine how marketing channels work together and may take that into account when drafting new guidelines.

"We have guidelines that were mostly born out of the media landscape we had a decade ago, and they were appropriate rules for that era, but now all of these [channels] are converging" - such as broadcast, print and the Internet, Smith noted in an interview. "It's a great time to look at some of those original rules and look at where the updating makes sense."

Looking to the FDA's list of posted questions for the meeting, Smith said that "a lot of the questions relate to the extent of [a company's] responsibility to discover information and correct information ... but there is a shortage in that list of items that address the convergence of media."

The FDA is asking the public to weigh in on several factors: when the use of search links is appropriate; what communications companies should be accountable for; how pharma can fulfill regulatory requirements, such as fair balance, in Internet and social media promotion; and what parameters should apply to posting corrective information on Web sites controlled by third parties (Also see "DDMAC 2.0: FDA To Host November Meeting On Web And New Media Promotion" - Pink Sheet, 18 September, 2009.).

But convergence, despite falling through the cracks on the agency's list, is particularly relevant, Smith said. A lot of drug marketing on the Web and in newer mediums, such as the video site YouTube.com, is shaped by what appears in print and TV ads.

But despite these similarities, real differences are evident across mediums. For example, an Internet doesn't have a "back page" akin to a magazine ad where further information can be displayed.

Already, the agency has sent out warning letters to companies about insufficient risks/benefit information presented on the Internet. Most notably, 14 agency letters went out to companies in April regarding Internet search links.

Revisiting the "one click rule"

Since most major drug makers received an FDA letter for cited search links, how best to address risk/benefit information is sure to be a hot-button topic at the upcoming meeting.

But when it comes to presenting risk information, FDA already has taken a strong stance that full prescribing information must be present on any page or item that makes a promotional claim.

Just one month after sending out the search link letters, the agency cited two companies for a journal ad and sales aids that did not include full risk information on every page - showing that fair balance rules apply across mediums (Also see "FDA Stresses Importance Of Fair Balance; Warning Letters Continue To Climb In 2009" - Pink Sheet, 20 May, 2009.).

Still, Bill Drummy, chief executive of Heartbeat Digital, asserts that labeling information on the Internet should be "one click" away from advertisements. "Pharma is not taking advantage of technologies because the FDA has tied its hands," Drummy pointed out while speaking at the DTC Perspectives conference on Oct. 14.

At the conference, Drummy presented a list of talking points firming up Heartbeat Digital's position prior to FDA's public meeting. These include:

· FDA should allow companies to host conversations with clearly stated posting guidelines.

· Marketers should only be required to remove inappropriate remarks after posting and not be held liable unless the error came from a paid contributor.

· Disclosures reflecting any kind of potential author bias should be noted in context.

· Label information should be one click away from advertisements.

· Suggestions offered for how to tag tweets (made through the micro-blog Twitter), comments and posts from pharma companies.

-Carlene Olsen (c.olsen@elsevier.com)

Upcoming FDA Internet Marketing Meeting Generates Buzz At DTC Summit

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