How To Market A Drug Off Label
8 CommentsBy Ed Silverman // November 4th, 2009 // 8:21 am
With all the controversy over off-label promotion - you know, huge settlements in the billions of dollars paid by this or that drugmaker for violating federal law governing such activities - one would think that the pharmaceutical industry would become a little more discreet.
Then consider Named Patient Programs. These are compassionate use programs through which patients can be prescribed investigational or approved drugs prior to their commercial launch - outside the US, that is. In other words, such a program fields requests from docs on behalf of patients to receive a med before its licensed in the patient’s home country.
This is a worthy goal, to be sure. Compassionate use is an important way to ensure a patient receives a potentially useful treatment that may not otherwise become available. However, there is a bit of a cottage industry springing up to remind drugmakers of the benefits they may receive as well. For instance, an upcoming webinar offers this pitch:
“These programs are a legal and ethical way to effectively manage pre-approval access and can bring significant value to the sponsoring company. Benefits include physician engagement and education prior to launch, KOL development, real-life data capture outside the scope of a clinical trial, and new opportunities for optimizing the product lifecycle.”
The concept isn’t brand new - some companies already have Named Patient Programs (here is another pitch from 2006). However, 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. The theme was discussed in a September 2008 article in the Journal of Medical Marketing entitled ‘Implementing a Pre-launch Named Patient Program - Evidence of Increased Market Share’ (subscription required).
It also raises a question about outcomes. Side effects are required to be reported to European Union member states, for instance, but what about disappointing results? These programs, which can be used to gather info for a US launch, are not the same as randomized clinical trials or may not involve enough patients, in any event, to provide meaningful insights. To what extent might disappointments concerning, say, efficacy work there way into FDA filings?
Compassionate use is to be commended. But given the recent industry failure to adhere to rules about off-label activities - Shire chief executive Angus Russell says it is now ‘normal practice’ to receive subpoenas about such things - what happens when named patient programs are increasingly seen as just another marketing tool? And who will provide proper oversight?
Anne PME
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.
Been There
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.
pharmavet
They’re called MSL’S.
more
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.
Justice in Michigan
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.
Justice in Michigan
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.
Chris
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).
BP Watch
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!