Michael Causey, Editor & Publisher, eDataIntegrityReport.com
Maybe things really are changing at the Food and Drug Administration. The FDA says it really wants to hear what you think about the job it’s doing. They’ve just set up a new blog [http://fdatransparencyblog.fda.gov] as part of their new “transparency” campaign.
It appears to be a genuine effort by the agency to reach out to its customers — that’s all of us — and try to do a better job of regulating devices, drugs and food.
It’s early days yet for the blog, but already it’s looking like a pretty lively place. And the FDA better be prepared to hear some things it may not like hearing. For example, a recent commenter on the blog said,
“FDA’s lost its way and must go back to the original intent to find it. Without that, FDA’s been left alone too long pursuing its own goals and now can’t find its way home. Who will lead FDA back home? The transparancy police? Not likely.”
Ouch.
And here’s an interesting – and accurate – point made by someone who identifies himself as a long-time employee in the medical device industry,
“Due to lack of formal policy on topics like online advertising, medical and pharma [companies] have to second guess the FDA’s stand on many emerging issues. It’s a bit like driving on a road with no posted speed limit – where the limit is established by the first person to get a speeding ticket (or in this case an FDA Letter).”
That’s a complaint I’ve heard echoed by many device and drug companies. And don’t even get them started on the status of the “new” 21 CFR Part 11, or what’s the latest on the eMDR initiative.
If you still need more room to rant beyond the new blog, you can also submit electronic comments to the federal register at www.regulations.gov, submit written comments to the Division of Dockets Management, or attend a public meeting June 24, 2009, in downtown Washington DC with some members of the Task Force.
Click here for additional details about how you can engage with the Task Force.
