DDMAC is nearing completion of the first in what is expected to be a series of guidance documents pertaining to appropriate drug promotion on the Internet and with social media tools.

Nearly a year after a lengthy public meeting on the subject, the Division of Drug Marketing, Advertising and Communications could produce the first social media guidance document by the end of December.

DDMAC Director Thomas Abrams said the series of guidances will address specific issues related to Internet drug promotion. They will not address how to use specific social media tools like Facebook, YouTube and Twitter because Internet technology evolves too fast.

Abrams did not say how many guidances could be produced, but said there are about five major issues to be covered in one or several documents.

“What we’re going to do is address questions like how to respond to unsolicited requests for information, what’s the corporate responsibility for correcting and monitoring third party sites for misinformation, what’s the corporate accountability for having people post promotional videos and things like that,” Abrams said Oct. 12 during a Food and Drug Law Institute conference on enforcement.

Abrams’ list of the pertinent issues mirrors some of the questions the agency wanted answered during the public meeting on Internet and social media drug promotion held in November 2009.

Other questions asked at that hearing included how manufacturers can fulfill regulatory requirements using social media tools with limited space requirements, such as the microblogging site Twitter, and when the use of links to other websites is appropriate.

[Editor's note: The Pink Sheet is sponsoring a webinar on how to navigate changing trends in promotion and advertising. The Oct. 21 event will feature former FDA Associate Chief Counsel Arnold Friede, who will discuss the agency's current and upcoming enforcement priorities. To register, call 800-332-2181, email custcare@elsevier.com, or visit http://pages.elsevierbi.net/AC090710LP .]

Industry has called for FDA to explain definitively how it wants Internet drug promotion to function. Some called for the agency to issue guidance along with regulations (Also see "Advertising Regulation Wiki? Industry Wants Authoritative But Frequently Updated FDA Guidance (And/Or Regs) On Internet Drug Promotion" - Pink Sheet, 22 March, 2010.).

Until last year’s meeting, FDA had told companies to apply existing broadcast and print policies to Internet advertising.

Agency Tiptoes and Develops Guidance

While guidance has been in development, DDMAC has taken a few positions on how it expects industry to use the Internet. So far the overriding principle the agency has communicated is efficacy claims must be accompanied by risk information.

FDA also has debunked the concept of a “One-Click Rule,” although that policy may come into question again with ads directed at smartphone users (Also see "DTC Smartphone Ads Present An “Interesting” Problem For DDMAC" - Pink Sheet, 18 October, 2010.).

The agency established a social media working group consisting of about 20 DDMAC and other officials to determine best practices for the use of social networking sites and the Internet.

Earlier this year, the group decided to review an application for an iPhone App. It was a unique case for DDMAC because it is a common-use technology. The agency typically reviews specific ads, not broad templates.

Several Apps already populate Apple’s App Store, but were not subject to review because they were unbranded, meaning they were not drug-specific (Also see "FDA Social Media Group Reviewing Its First iPhone App As DTC Marketing Tool, But It's Not The First To Be Released" - Pink Sheet, 19 April, 2010.).

DDMAC also cited Novartis for including a widget on its website that posts links about one of its drugs on Facebook. Because the widget did not include risk information and broadened the Tasigna (nilotinib) indication, DDMAC told the company to stop using it (Also see "DDMAC Dislike: FDA Cracks Down On Facebook Widget Used On Tasigna Website" - Pink Sheet, 5 August, 2010.).

Likely the most famous of the agency’s Internet policing came last year, when it sent notice of violation letters to 14 firms indicating sponsored search ads violated rules because they did not include risk information along with efficacy claims (Also see "Internet Promotions Must Be Redesigned After FDA Cites Sponsored Web Links" - Pink Sheet, 13 April, 2009.).

The new social media guidance is nearing completion as DDMAC is seeing what Abrams called a “remarkable” increase in the number of filings for Internet-based advertisements. The agency is shifting more enforcement resources toward the medium as a result.

By Derrick Gingery

FDA's Internet Promotion Guidance: One Down By Year-End; Four More To Go?

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