An Insider Discusses Off-Label Promotion Tricks
7 CommentsBy Ed Silverman // October 23rd, 2007 // 6:47 am
This is basically a brief overview on the subject. Doug Melnick, a preventive medicine physician who is billed as a ‘pharma insider,’ tells Adriane Fugh-Berman of PharmedOut about the various ways that drugmakers can get around the prohibitons against off-label promotion. Melnick, by the way, is also a consultant to the organization.
Hank
Perhaps someone can explain this to me.
Typically, the “think tanks” that push hardest for FDA preemption also lobby for far looser restrictions on off-label promotion.
So the question arises: If the FDA’s expert and scientific determinations ought not to be “second-guessed,” why would one also push for essentially unfettered rights to promote drug uses that FDA has not approved?
Of course, I know how some would answer in terms of motive. I am looking for a reason with that has logical, abd not only psychological/fiscal, consistency.
Jack
The example alluded to in the video involves a pediatric patient that needs chemotherapy. Very few drug companies pursue approval for their drugs in a pediatric patient, because (depending on the type of cancer) it doesn’t make financial sense to get approval for such a small population. In fact, many (I would guess most) drugs that do get approval in a pediatric population for any indication get that approval to extend the patent life of the drug (because the FDA wants drugs studied in pediatric patients patent law gives the company an extra 6 months of market exclusivity for testing the drug in a pediatric population). However, doctors still encounter occasional pediatric patients that need treatment for these diseases (or if they work at a children’s hospital like St. Jude they encounter them all the time). So the doctor can look in the literature and call the company. The company provides the doctor with whatever information (written or orally) it does have, to inform the doctor. The logic here is that guiding clinical care with limited information is better than no information, and thus the FDA permits this sort of dissemination.
The connection you’re trying to create, between this off-label “promotion” (your words) and pre-emption of labeled use doesn’t really exist because the information *should* only be distributed when the doctor asks the company for the information as an unsolicited request. By definition, this off-label dissemination is non-promotional because the company can’t legally use it promotionally. The laws in this area, and the scenarios described in the video point out the grey areas in these laws, but if off-label promotion is occuring it’s illegal.
I also suspect that most people who read this blog (or at least post on this blog) who read my post will assume that the information disseminated from the companies contains a lot of bias, and promotes the positive features of the drug. To them, (if they are a healthcare professional because most companies won’t send out the stuff to non-healthcare professionals) I challenge them to call 10 random pharmaceutical companies about 10 random drugs with 10 random questions. Examine the information you receive for promotional bias. I don’t think you will find much (any?) promotional bias in these materials.
Ed Silverman
Hi Jack,
Points well taken, although I’m always curious to hear more from others to gain additional, and perhaps, opposing insights. In any event, I used the word ‘promotion’ simply because that’s how PharmedOut bills this video clip. You can see that by going to the link I provided to their site.
And there are actually many industry people who read this site, but not all post comments here for various reasons. I’m sure you can imagine one or two. There is, however, a vociferous slice of our readership who may, as you say, assume such company info is biased. But I would hesitate to say they represent a majority. More likely, they don’t have work-related inhibitions. As someone who must read all the comments, I can say that a healthy mix visits us.
Thanks for stopping by,
ed at Pharmalot
Hank
Jack - I think you misunderstood my post. I was referring to groups like the Washington Legal Foundation which have been fighting long and hard _against_ the restrictions on off-label promotion (their word).
You accurately describe the situation as it stands. The point is that groups like the WLF would like to change the situation as it stands.
Here is a brief excerpt from one of their 2005 white papers related to fighting limits on off-label promotion (once again, their word) in the courts: “FDA will need to establish that off-label promotion will gut the product approval process, pose some real risk to patients, or is “inherently misleading†if it expects courts to uphold off label restrictions.”
The overall philosophic rationale is freedom of commercial speech. And the question is the extent to which freedom of commercial speech and FDA preemption over a drug’s uses and indications can be held consistently.
Hank
To close the circle, I should have added that the WLF - with whom Daniel Troy has worked closely - has also been in the forefront of the campaign for FDA preemption.
Janet
I just took at look at the WLF site. Their FDA/DDMAC campaign (i.e. writing letters to the FDA to request the withdrawal of individual warning letters) is pretty distressing. Free speech for all pharma companies even if it is misleading? Fine until somebody PROVES that it poses some real risk to patients? Under what circumstances do they expect this will happen (particularly if they are supporting FDA preemption)?
Hank
In the mid-90s, The WLF was at the forefront of the efforts, spearheaded by Gingrich, to return us to, in effect, a pre-thalidomide FDA.
Needless to say, if one is viewing things from an “unfettered market” perspective, radically downsizing both FDA regulation and civil liability make mutual sense.
If you gain control the FDA via political appointments, and then gut it from the inside, that serves the same purpose. You grant it full all-encompassing power (preemption) while strictly limiting the power it has.