The pharmaceutical industry is seeking a path to participation in social media and the Internet without running afoul of FDA's promotional no-no's and appears willing to help pay for it.

"We'd have to look at any proposal for ... user fee funding for DDMAC [Division of Drug Marketing, Advertising and Communications]," Pharmaceutical Research and Manufacturers of America Assistant General Counsel Jeffrey Francer said March 9.

"But we have supported user fee funding to help DDMAC do its job in the past," he noted during a press briefing to discuss PhRMA comments to FDA on how drug promotion on the Internet should be regulated (Also see "Who's Liable For Online Content? Pharma, Marketers Disagree (Slightly)" - Pink Sheet, 30 November, 2009.). The FDA Amendments authorized user fees to pay for DDMAC to review direct-to-consumer television ads, but Congress never appropriated money for that activity.

PhRMA reiterated its call for a universal symbol for use in space-constrained media, such as sponsored search results, to indicate a direct link to FDA-regulated risk and benefit information (Also see "PhRMA's Web Search Solution: Add Icon Or Generic Risk Statement In Results" - Pink Sheet, 9 November, 2009.).

FDA would set standards for using that symbol, and once the standard is set, "companies can then go forward and FDA can review the use of the standard, just as they review promotional pieces now," Francer explained.

If FDA allows use of a symbol, he noted, the agency will have to come up with enforcement protocols and work with the Federal Trade Commission, which would be responsible for going after non-pharmaceutical entities that counterfeit the symbol.

Using the symbol in sponsored search results would be a good way to roll it out, Francer suggested, because then operators of the search engine "would enforce the use of the symbol, and they already talk directly to manufacturers and those who buy advertising on the search engine."

PhRMA's comments to FDA included two formats for the sponsored search results - one with, and one without, the universal symbol, which the group considers to be a risk statement. "PhRMA is amenable to either. We're trying to provide formats that are appropriate for new media and the Internet, and so in one format we have a universal risk statement. The second one is a more customized statement which would be introductory risk information with the continuation after a click," Francer said.

Bayer has used a format proposed by Google in its sponsored search results for the oral contraceptive Yaz . (Also see "Bayer Tries Google Format To Keep Yaz Name In Sponsored Link And Meet Risk Requirements" - Pink Sheet, 25 November, 2009.). Sponsors have been looking for a way to provide fair balance in that venue since FDA issued warning letters to 14 firms last year for failing to include risk information there (Also see "Internet Searching May Get ‘Riskier’ For Patients After FDA Citations" - Pink Sheet, 6 April, 2009.).

Guidance on using Twitter or other microblogging technologies to report newsworthy events, such as drug approvals, also is on PhRMA's to-do list for FDA. The agency "should provide standards to help manufacturers differentiate between what information would be considered promotion and what information would be considered scientific exchange," Francer said.

-Cathy Dombrowski (c.dombrowski@elsevier.com )

PhRMA Open To User Fees To Support Oversight Of Internet Drug Promotion

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