Comments on: How To Market A Drug Off Label

By: BP Watch

BP Watch — Thu, 05 Nov 2009 16:33:39 +0000

Let’s get this out front. Off-label promotion is ILLEGAL and violators as well as those who should be processed to the fullest extent of the law! Truth is that top execs and commercial management do whatever they want to increase profits and get away with murder! Then they walk away all the way to the bank. Disgusting!

MSLs, MSSs - and whatever else you call them - are typically scientists who behave as super-salesman. One question or one form signed by the doc opens up a huge can of worms and the opportunity to push off-lable. It’s acon game!

By: Chris

Chris — Thu, 05 Nov 2009 13:01:32 +0000

Allergan is suing to be able to PROACTIVELY communicate benefits and risks of their drug in off-label use, despite the fact that under current regulations they are already allowed to provide this information upon physician request (by medical science liasons)(MSLs).

By: Justice in Michigan

Justice in Michigan — Thu, 05 Nov 2009 02:31:26 +0000

whoops…missing pieces at the end. Should have been: “fear-mongering as a political/commercial strategy appears to have significant pay-offs.”

Nothing new, of course.

By: Justice in Michigan

Justice in Michigan — Thu, 05 Nov 2009 02:28:43 +0000

This puts Allergan’s suit against FDA in an interesting context. As many here will know, Allergan is suing in order to be able to communicate alleged risk info to docs who are already using Botox off-label. The suit is obviously aimed at making the limits on off-label promo look like they are putting pts at risk. It’s the same essential strategy that the preemptors (mostly the same folks) have used re: “dangerous overwarning,” etc..

As recent history demonstrates, in any event, however, fear-mongering a politica/commerical strategy appears to have signific pay-offs.

By: more

more — Thu, 05 Nov 2009 02:15:20 +0000

What’s an “MSL”?

I admire the craft that went into this sentence: ” the notion is now clearly part of the marketing plan with, arguably, a subtle emphasis on benefiting the company as much as, if not more than, the patient.”

Wow. I confess that the dead rat of the other thread would have been a lot less nuanced.

By: pharmavet

pharmavet — Wed, 04 Nov 2009 16:59:10 +0000

They’re called MSL’S.

By: Been There

Been There — Wed, 04 Nov 2009 15:55:46 +0000

Anything to make more money. Big Pharma has it all figured out. Problem ia that the Federal Government has finally started to catch up with them. More power to the OAG, DOJ, OIG, FDA and all of the other sectors of governement tasked with watching these callous beasts.

By: Anne PME

Anne PME — Wed, 04 Nov 2009 14:36:22 +0000

The information appears to have left out that under FDA compassionate use, you are more likely to be able to get the patient to pay the full out of pocket costs for the medicine and accompanying tests out of pocket without having to grapple with difficult to deal with insurance executives and oversight officials.

Why, because these patients are usually desperate for life saving treatments.

Also, the insurance co. can invoke the experimental treatment clause that is included in most policyholder certificates of coverage.

Also, there is FDA personal use. This went into effect in large part bc/ of the AIDS crisis.

Here is one of the bigger problems. If the medicine has to be injected, there is more liability and the patient is likely to have problems finding a facility to administer the medicine. Medical malpractice insurance companies and risk managers are also very likely to really frown on doctors and facilities who go outside the scope of normal reimbursable activities to keep their patients alive and well.

Maybe we should be thinking about this…about what health care is really about and really for as we grapple with health care reform.