What is the FDA knew?

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Anonymous

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What if the FDA knew about our regional meetings and being required to do role play on a study that is dissemination only??????? How does Abbott get away with some of the things they do???
 








And Abbott legal,.. puts more & more of the risk soley on the 'backs' of the field sales force,... nice rigged game that,... I'd like to see anyone from legal work in field sales for 6 months & increase Niaspan/Simcor business under the draconian boundaries THEY put in place,.. read the Pharma Guidelines & then see how exaggereated Abbott legal's interpretation is,... it is not the FDA they are concerned about,.. it is competitors legal team making threats to fine them,..
READ THE DAMN PHARM-GUIDELINES,..
 












you are a complete idiot if you really believe this. Never have we used those reprints. We are not supposed to use those. You are the kind of rep who gives everyone a bad name because you don't know what the hell is going on.
 




The FDA knows that we are still actively promoting two drugs that have not only done nothing to advance patient care in two NIH studies but have also caused harm to specific groups within those studies! At bare minimum our circulars should contain warnings against using fibrates or niacin in any diabetics, elderly & women specifically and yet we've done nothing to tell physicians and continue to prevaricate and drag our heels! My manager told us to stay away from any information on ACCORD or AIM-HIGH until those studies are confirmed..which they'll never be until the drugs are off patent and will mean nothing to our bottom line!
 












Anonymous said:
I just want to know what the FDA would do if they knew.
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What would you like the FDA to do? They can't do anything. It's your meeting, and if management expects you to know and articulate the contents of the study, so what? As long as you don't discuss it in the field with a HCP, it's none of the FDA's business.
 








Anonymous said:
What would you like the FDA to do? They can't do anything. It's your meeting, and if management expects you to know and articulate the contents of the study, so what? As long as you don't discuss it in the field with a HCP, it's none of the FDA's business.
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There is certainly a very strong suggestion that they are encouraging and condoning that we use off label and unauthorized material with doctors by drilling us on them.
That is not a big leap of faith. Not appropriate at all.
 




Anonymous said:
The FDA knows that we are still actively promoting two drugs that have not only done nothing to advance patient care in two NIH studies but have also caused harm to specific groups within those studies! At bare minimum our circulars should contain warnings against using fibrates or niacin in any diabetics, elderly & women specifically and yet we've done nothing to tell physicians and continue to prevaricate and drag our heels! My manager told us to stay away from any information on ACCORD or AIM-HIGH until those studies are confirmed..which they'll never be until the drugs are off patent and will mean nothing to our bottom line!
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Poster is bang on.

Question is now is how bad will it get when AH is published or presented. At that point the FDA will tell us what to do and say.
 




Anonymous said:
There is certainly a very strong suggestion that they are encouraging and condoning that we use off label and unauthorized material with doctors by drilling us on them.
That is not a big leap of faith. Not appropriate at all.
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Agree. If we get caught or in trouble they will try to look away and then term us. I am keeping real good notes.
 




Anonymous said:
What would you like the FDA to do? They can't do anything. It's your meeting, and if management expects you to know and articulate the contents of the study, so what? As long as you don't discuss it in the field with a HCP, it's none of the FDA's business.

Spoken like a true Ab BOTT manager
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Not an Abbott manager. Not even employed by ABT. Was laid off in January and still check this site to see what's happening there. But what's the big deal about this? If you're so concerned about what the FDA would do, TELL them! Then you'll know they won't do anything. It's a gov't institution, they don't move their asses unless they have to.

If your concern is that you are being railroaded by management to sell off label, TELL THEM! Tell them you won't do it. What the hell, in six months most of you in dyslipidemia will be gone anyway.

If this is one of those BS "Four square" exercises, don't pick that reprint to detail from. If you are made to use it, role-play it, "Doc, I'm leaving this reprint for your review, if you have any questions, call Med Info."

Don't you know yet how to play this stupid game?

I repeat, as long as you don't actually discuss this reprint with a HCP, the FDA can't/won't do anything.
 




Anonymous said:
Not an Abbott manager. Not even employed by ABT. Was laid off in January and still check this site to see what's happening there. But what's the big deal about this? If you're so concerned about what the FDA would do, TELL them! Then you'll know they won't do anything. It's a gov't institution, they don't move their asses unless they have to.

If your concern is that you are being railroaded by management to sell off label, TELL THEM! Tell them you won't do it. What the hell, in six months most of you in dyslipidemia will be gone anyway.

If this is one of those BS "Four square" exercises, don't pick that reprint to detail from. If you are made to use it, role-play it, "Doc, I'm leaving this reprint for your review, if you have any questions, call Med Info."

Don't you know yet how to play this stupid game?

I repeat, as long as you don't actually discuss this reprint with a HCP, the FDA can't/won't do anything.
Click to expand...

No I didn't know and I will definitely say this. "Doc, I'm leaving this reprint for your review, if you have any questions, call Med Info."
 




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