Friday, January 20, 2012

'Twas the Night Before New Year's...

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Casey Ferrell is a research analyst at Cutting Edge Information. He will be guest blogging at IIR’s upcoming ePharma Summit 2012 (February 6-8, 2012 in New York City). You can find him on Twitter or over on his company’s blog.
 
... and all through the house,
Not a creature was stirring except for my mouse.
I returned from vacation, I checked email and snail mail,
I dashed over to Twitter; I had missed seeing Fail Whale.
But something was amiss; #socpharm was achatter,
I sprang from my desk to see what was the matter.
Away to Windows 7, I flew like a flash,
Tore open my Tweetdeck, and threw up the hash(tag).
When, what to my wondering eyes should appear,
But a Guidance! Oh Joy! It’s finally here!
But wait, what’s this? What’s this bulky title?
It’s not what we thought. This is a false idol.
Off-label requests and how to respond?
I couldn’t help but feel that we’d all been conned.
More rapid than eagles the pundits they came,
And they whistled, and shouted, and set the Interwebz aflame:
"To the blog! ToTwitter! To the new Facebook wall!
"Now dash away! Dash away! Dash away all!"
The next two weeks saw the blogosphere explode,
With more than sixty posts attempting to decode,
This FDA Guidance of Near-Mythical Proportions
That had us in various states of contortion.
It’s too short! It’s too shallow! There’s nothing here new!
We wanted to see something on which we could chew!
But fear not, pharmateers, cooler heads have prevailed,
The guidance, while narrow and modestly scaled,
Is a document of promise that once I had read,
Soon gave me to know I had nothing to dread.
It wasn’t a document to dismiss or condemn,
But a little wayfinder for the Spitzes and Shwens.
A handy little piece of non-binding regulation,
Acknowledging all of the wild speculation,
Around if and how pharma could ever be enabled,
To respond online to stuff that’s off-label.
So now we know what to do on this front,
Let’s hope going forward the FDA doesn’t punt.
Just think, with more guidance, maybe five or six more,
We’d be deep into digital where we haven’t before.
As I sat back and breathed and began my perceiving,
I was shocked yet again by a guy who was leaving.
None other than Boy Wonder, the wise and sage Jon,
Announced a new venture he was ready to try on.
He sprung to his sleigh, to his Tweeps gave a whistle,
And away he then flew, like the down of a thistle:
But I heard him exclaim, ere he drove out of sight —
Happy Pharming to all, and to all a good night.
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