"My sources inside the agency (but outside of DDMAC) tell me they were caught by surprise by these new DDMAC letters," says Peter Pitts, author of Drug Wonks, which is widely read by the pharmaceutical industry (see "Sponsored Links: Implications & Applications").
"What does this mean? Does it expose the probability that this important social media issue was not discussed at higher levels? You be the judge – but you can bet they will be now. In fact, I wouldn’t be at all surprised to see this issue discussed at a sitting of the Risk Communications Advisory Committee."
MY sources tell me that FDA Intern is tracking down who discussed these letters at higher levels in the FDA.
Yes, it's FDA Intern! Strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even former FDA commish Andy von Eschenbach!
FDA Intern! Who can change the course of mighty clinical trials, approve drug ads faster than a speeding bullet, jump through Congressional Subcommittee hoops of fire and ire, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great regulatory agency, fights a never ending battle for fast-track drug approvals, pharmaceutical company user fees, and the FDA way!(Click for an enlarged view. Print it and show your friends!)
"In fact," says Pitts, "[the issue] should have been discussed before the letters were sent out in the first place – that’s what advisory committees are for. But that’s just my opinion."
Better be careful Mr. Pitts! You might just get what you wish for and MORE -- ie, Sydney Wolfe sitting on that advisory committee!
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