FDA hearings focus on need for guidelines

WASHINGTON: The pharmaceutical industry and healthcare communicators advocated for guidelines that would define the way they use the Web to communicate during the Food and Drug Administration (FDA)'s two-day social media hearings.

WASHINGTON: The pharmaceutical industry and healthcare communicators advocated for guidelines that would define the way they use the Web to communicate during the Food and Drug Administration (FDA)'s two-day social media hearings.

The federal agency scheduled the hearings, held November 12 and 13 in Washington, to gather information from drug makers, PR and advertising agencies, Internet companies, and consumer advocates about how the Web and social networking sites are being used to promote and communicate FDA-regulated products.

The FDA currently uses the same rules regarding fair balance and risk information for print, TV, radio, and online communications.

While some view the hearings as an opportunity to push for guidelines that could free pharmaceutical and medical device companies from the regulatory and legal concerns they face when communicating on the Web, others see the potential for increased regulation that could affect the online tools they are already using.

“There's a tremendous degree of redundancy, which is a good thing,” said Peter Pitts, director of the global healthcare practice at Porter Novelli. “People are saying the same things. They're presenting the research that upholds the same conclusions.”

Pitts, along with several other PR professionals, presented at the hearings.

"Companies are hungry for guidelines, but a bit apprehensive about how the FDA might choose to clamp down on marketing activities that they currently employ," said Rohit Bhargava, SVP of digital strategy and marketing for Ogilvy PR Worldwide, by e-mail.

He said that he expected to hear more contention about whether or not pharmaceutical brands should be sharing health information online.

“I think the most important idea from today is the concept that marketing content [can] have real value when it comes to helping patients and healthcare professionals to understand a condition better,” said Bhargava by e-mail. “Just because it is promotional content doesn't mean that it must be inherently sales focused and devoid of something meaningful to say.”

Many presenters introduced ideas, such as PhRMA's suggestion to create a FDA icon to inform patients that a Web site they were visiting had the proper risk and benefit information. Presentations from companies like Google and Yahoo looked at issues related to paid search.

Emily Downward, SVP of digital health for Edelman, which plans to submit written comments, said that she had hoped more focus would have been placed on communications.

"We've seen a huge impact in paid search since the FDA letters came out in April," she said. "I don't think when the FDA did that they were thinking about the communications aspect. If there's a recall or a side effect issue or something that needs to get out to the public, paid search is an excellent way to get to people."

Rick Wion, VP of interactive media at GolinHarris, spoke the morning of November 13, recommending a widget that would gather adverse events and relay them directly back to the FDA instead of through the pharmaceutical companies first.

The FDA said it is gathering feedback and additional data and information until February 28, 2010.

Updated November 13, 2009, 11:13am

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