Industry, Government Grapple With New Frontier in Day 1 of Hearings
NEW YORK (AdAge.com) — PhRMA is advocating for a universal safety symbol — either the FDA logo itself or an FDA-approved symbol — to indicate that a Twitter or Facebook mention links to a page that contains the pharmaceutical company’s FDA-mandated risk information.
The lobbying group for the pharmaceutical industry made its case during the first day of the two-day U.S. Food and Drug Administration public hearings in Washington. The hearings are designed to establish guidelines for how pharmaceutical companies go to market on the web and social-media sites.
And while 31 speakers representing such power players as drug maker Eli Lilly and search giant Google each had 15 minutes to present their respective cases to a 12-member FDA panel, perhaps none was more compelling than the Pharmaceutical Research and Manufacturers Association, which caught the panel’s attention.
The panel, led by Thomas Abrams, the FDA’s division of drug marketing, advertising and communications director, peppered PhRMA assistant general counsel Jeffrey K. Francer with questions after his presentation had concluded.
“Consumers on the internet are accustomed to viewing pop-ups, rollover text, links and other communication mechanisms,” Mr. Francer said. “FDA should recognize, as the [Federal Trade Commission] has, that space limitations in certain formats warrant allowing certain long warnings to be accessed using a prominently labeled hyperlink.”
Lack of guidelines
The lack of regulatory guidelines for marketing via tools such as Twitter, Facebook, blogs and websites, came to a head in April of this year when the FDA sent warning letters to 14 companies for search-engine ads that the FDA said violated regulations regarding presentation of fair balance. The reaction from drug makers, health-care ad agencies and internet sites was unanimous — it’s impossible for the same risk information that is conveyed in a 30-second television spot or a full-page magazine ad to be duplicated in a 140-character Twitter message or internet banner ad, hence the need for a defined set of guidelines for Web 2.0 marketing.
According to TNS Media Intelligence, internet spending by drug makers zoomed 36% to $137 million last year but, according to a report from PricewaterhouseCoopers, that represented less than 2% of the $10.9 billion spent on online advertising. In part, that was due to a lack of regulation and a fear by drug makers of FDA retribution.
Michele Sharp, senior director of U.S. regulatory affairs for drug maker Eli Lilly, said the dubious rules regarding internet advertising are so ambiguous that her company has, reluctantly, not pursued online and social-media marketing as it should.
Though the public-hearing process takes months to play out, Tiffany A. Mura, managing partner/director-digital for Boston-based Consensus Interactive, urged the FDA to institute its guidelines sooner than later.
“Guidelines need to be implemented in 2010,” Ms. Mura said. “Months are the equivalent of years on the web.”
Need for clarity in online advertising
Yahoo VP-General Manager of Display Advertising David Zinman said there’s a need for greater clarity in advertising online.
“We firmly believe the ad rules should be commensurate with the media,” he said.
Craig M. Audet, VP-regulatory affairs marketed products for pharma giant Sanofi-Aventis, noted that 83% of all internet users look online for health information, according to Pew Research, and he likened the conversation between a company’s website and a consumer to a conversation between a sales representative and a physician.
“I would say that any postings online would have those same characteristics,” Mr. Audet said.
Some 32 speakers are scheduled to present on Friday. The FDA said it received more than 800 registrants wishing to speak at the public hearings.
By Rich Thomaselli
Published: November 12, 2009