The all-day hearings, scheduled for November 12 and 13 in Washington, will give the industry a public opportunity to advocate for the promotion of drugs, biologics, and medical devices in the online space. The federal agency plans to use the information gathered at the hearings to "help guide FDA in making policy decisions," according to the registration.
“The hearing is the very beginning of a much longer dialogue between the FDA and industry over what social media means and what companies could potentially do,” said Bob Pearson, chief technology and media officer for the WeissComm Group.
The FDA maintains that marketing efforts, including TV, radio, print, and online, are subject to the same rules regarding fair balance and risk information.
In April, the agency warned 14 pharmaceutical companies about their use of “misleading” and “misbranded” Internet ads, prompting confusion among drug companies using online communications.
Many communicators hope the hearings will lead to guidance specific to the Web and social media.
“From a client's perspective, any guidance will be better guidance than what they're getting right now from the FDA in this space,” noted Kelly Dencker, SVP and healthcare practice director at MS&L Worldwide. “There is some skepticism about how quickly they will move and there's concern about how clear the guidance will be.”
A handful of leaders in the PR industry are slated to speak at the hearings, including Larry Weber, chairman of Racepoint Group, who said that many of the firm's healthcare clients are concerned about the hearings.
“I think they're extremely concerned that the FDA doesn't get what's happening, that they don't get that a whole new generation of people is very comfortable sharing information on the Web,” he said. “We hope the FDA will learn that it's more about a positive use of social media and the Web to get their messages and products out.”
Dencker said he hopes that guidelines will be issued by late spring or summer of 2010, following additional hearings and sub-meetings.
“Knowing the FDA, they want it to be right the first time and so there's going to be tremendous feedback,” he added.
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