FDA Compliance

Quote




































anonymous said:
Drug is gone, do not think the FDA is even caring about this supposed issue. Ask a doctor, most are afraid of the drug. The off label thing is a joke.
Click to expand...

You must either be very naive, or new to pharma. Don't kid yourself, if inappropriate activity has gone on, or inappropriate patients were prescribed Lotronex, the FDA will have an interest. I've seen it with another company where the drug had lost patent, but people were still investigated.
 






anonymous said:
You must either be very naive, or new to pharma. Don't kid yourself, if inappropriate activity has gone on, or inappropriate patients were prescribed Lotronex, the FDA will have an interest. I've seen it with another company where the drug had lost patent, but people were still investigated.
Click to expand...
This was a beast of a drug to sell because doctors would barely rx it on label, are you joking about off label!! For all 20-30 prescriptions in your territory they were very on label for patients that had suffered for years. The volume alone shows on label use. They used it in their very very severe cases, 8+ bowel movements a day. Off label is laughable, with all the paperwork involved.
 












anonymous said:
This was a beast of a drug to sell because doctors would barely rx it on label, are you joking about off label!! For all 20-30 prescriptions in your territory they were very on label for patients that had suffered for years. The volume alone shows on label use. They used it in their very very severe cases, 8+ bowel movements a day. Off label is laughable, with all the paperwork involved.
Click to expand...

Boy, who was the dumbass who wrote this? Non-compliance is not about what the doctor did, it's about what the salesperson or manager said! How stupid are you?
 






anonymous said:
This was a beast of a drug to sell because doctors would barely rx it on label, are you joking about off label!! For all 20-30 prescriptions in your territory they were very on label for patients that had suffered for years. The volume alone shows on label use. They used it in their very very severe cases, 8+ bowel movements a day. Off label is laughable, with all the paperwork involved.
Click to expand...

And you know this detailed information HOW? Unless you were looking at patient charts, you don't know this specific detail ...
 






anonymous said:
Boy, who was the dumbass who wrote this? Non-compliance is not about what the doctor did, it's about what the salesperson or manager said! How stupid are you?
Click to expand...

If no rep promoted it off label, which no body but I guess you did, and no doctor wrote it off label, by volume and utility they did not, they the FDA is investigating what?? Nothing!!! Good luck with the next job, especially if you are telling the FDA you like to promote off label. No one else did, you just went rogue.
 






anonymous said:
If no rep promoted it off label, which no body but I guess you did, and no doctor wrote it off label, by volume and utility they did not, they the FDA is investigating what?? Nothing!!! Good luck with the next job, especially if you are telling the FDA you like to promote off label. No one else did, you just went rogue.
Click to expand...


Another moronic comment with no logic behind it. The one who is defensive of the company is the guilty one. Someone is running scared ...
 






anonymous said:
If no rep promoted it off label, which no body but I guess you did, and no doctor wrote it off label, by volume and utility they did not, they the FDA is investigating what?? Nothing!!! Good luck with the next job, especially if you are telling the FDA you like to promote off label. No one else did, you just went rogue.
Click to expand...


If I can butt-in on this conversation, the above statements do not help the company. In fact, it's Psychology 101 for someone to get so defensive and deflect accusations to someone else when they feel guilty. If there's nothing to hide, this person wouldn't be deflecting.
 






anonymous said:
If no rep promoted it off label, which no body but I guess you did, and no doctor wrote it off label, by volume and utility they did not, they the FDA is investigating what?? Nothing!!! Good luck with the next job, especially if you are telling the FDA you like to promote off label. No one else did, you just went rogue.
Click to expand...

Your diatribe is not very clear here...
 






This thread is booooooring!!! Boring. Come on haters....can't you think of something better to post about? Lotronex, compliance, off label, blah, blah, blah....and I fell asleep. Like to watch paint dry, much? There has to be something better....Alex, some idiot manager, we're all going to get laid off, the training department is incompetent, the home office is lame, etc. Come on!! Anything is better than this.
 






anonymous said:
This thread is booooooring!!! Boring. Come on haters....can't you think of something better to post about? Lotronex, compliance, off label, blah, blah, blah....and I fell asleep. Like to watch paint dry, much? There has to be something better....Alex, some idiot manager, we're all going to get laid off, the training department is incompetent, the home office is lame, etc. Come on!! Anything is better than this.
Click to expand...

Yeah, a lack of integrity is so boring.
 












anonymous said:
Thank god that you are here to remind us of integrity. And truth, justice and the American way! You are the caped crusader of integrity. Quick, grab Robin and it's off to the integrity-mobile to fight the next round of off label promotion! SHAZAM!
Click to expand...

That's "god" with a capital G, thank you very much...
 












Top Bottom
Back
Quote