I just had a Pennsaid speaker come to my office promoting off label and the rep is pushing this illegal behavior
Speakers can say whatever they want as long as they cover the fair and balanced legal presentation and are responding to a question. Even if they don't, it's not illegal for a medical professional to talk about non-indicated use of a med, it may be against pharma guidelines but it's absolutely not illegal. Oh, and you're not a medical professional either.
Elena......your company paid speaker and you are promoting Pennsaid off label..........your goose is cooked....................
So what's the federal, state, county, city, district, precinct or parish law that was broken? Those with medical licenses are allowed to talk about and use approved meds for unapproved conditions when they believe there is merit to the treament. If you think it's illegal you're wrong.
it's not illegal it is just down right sleazy. Our whole industry is based off of the fact we make money on helping doctors prescribe medication to patients. for better or worse that's how we earn a living. best not to bring right and wrong into job. hang out in the grey...
Paid speakers have to stay on label................go to the FDA website and read up What a doctor does with their patient as far as writing off label is another thing but promoting off label is totally wrong and whistle blowers are making a fortune on fines against off label promotion
Gosh....even with all of the speaker off label promotion talk I still cannot make my Pennsaid numbers or Exalgo numbers.
Poster #10 is right. Your speaker MUST disclose the product indication(s), but whatever other benefits they speak about regarding that drug, if off indication, it must be clear that it's off label. That's it...they don't have to expound any further. Now, they do have to work with the approved promotional deck your PRB folks put together, including fair balance, etc. There is a post-program survey and that includes a speaker evaluation. It will come down to the rep using their best judgement. Either scold or "advise" the speaker (usually an experienced writer of your drug or good potential) and blow future Nrx/Trx, or shut up about it and keep chugging...LOL. Let the games begin!
What's your problem with Elena? She must be kicking your ass! You posted crap in other threads with her name as well. Get a life, or learn how to sell against her.