Will the FDA hearings on social media, which kicked off today, result in guidance specific to online media? That's the question on the minds of digital gurus converging on the capitol for two days of presentations on using social media in drug and device marketing.
The FDA said it will draw on participants' suggestions to “help guide policy decisions.” Some say this is overdue.
Addressing delegates at the PRWeek Next Conference at the Waldorf Astoria in New York on the eve of the FDA hearings, Ray Kerins VP, worldwide communications, Pfizer, said guidelines are “sorely needed.”
Indeed, as Twitter and Facebook rapidly emerge as channels to reach patients and build online communities, drug company interactive managers are tempted but understandably reticent to use Web 2.0 tools, without clear rules on handling risk communication and adverse-event reporting.
Last March FDA issued untitled letters to 14 companies for omitting fair balance in sponsored links on search engines. The letters seemed to suggest that the traditional “one-click” rule—in which risk information is available on a landing page a single click away—does not suffice as does turning the page to get such information in a print ad.
Kerins said any guidance is better than none and that the FDA is trying to do the right thing. “Nobody should point the finger at the FDA and say this is their fault—because it's not.”
MM&M's senior editor, Matthew Arnold, is attending the hearings and will offer his insight and commentary in a roundup following each of the two days' testimony.