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Sins of omission: the FDA’s social media inaction puts patients and industry at risk
April 20, 2011
“Eighteen months ago, 80 of my closest friends and I presented before the US Food and Drug Administration on how the agency should regulate the promotion of medical products via the internet and social media1. Not long after the November 2009 hearings, I wrote in this very publication:
When might the agency issue some guidance for the industry? The smart money seems to be on ‘in about a year’, and given that the opportunity for public comment extends until mid-February 2010, that seems like a reasonable bet.
Seems we were being unreasonable. On 31 March 2011, the FDA issued a statement on its website, stating that it needed more time to state its position2. The agency said:
Policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities. Despite our limited resources and increasing workload, we remain committed to this area in terms of both time and human resources. It is difficult to provide a timeframe for the issuance of our guidances due to the extensive work and review process…
It’s difficult to see what the FDA has been doing concerning this ‘high priority’ for what seems like an eternity in internet time. Its response is the equivalent of an employee telling his boss, ‘Gee, it’s really hard and I’m really busy, but I’ll get to it eventually. And by the way, don’t ask me for a deadline.’ The difference being, of course, that although industry partially funds the agency and the American public is supposed to be its master, the FDA is one of these strange creatures of Washington that’s responsive only to frequencies none of the rest of us can hear.”
See the article in full on RAJPharma.com:
Source: Bill Drummy, CEO, Heartbeat Ideas as published in Regulatory Affairs Pharma Magazine.
Date Published: April 20th, 2011
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