Another interesting point to note is that the YouTube video represents the first time a warning letter has been issued for something posted on that site. And only the second one I know of issued for something exclusively online.

That said, it’s also important to note it’s not the site or the digital channel that was at fault — it was some basic rules the companies broke that would’ve been a problem no matter what the channel.

More discussion on my blog at http://intouchsolutionsdigital.blogspot.com/

We are about to elevate a number of publicly held companies to this new level of social standing. I think that this should call for a drastic restructuring of their top level management to come into alignment with what is customary for this new exempted status. Also maybe we should consider how to better control other aspects of their business practices including limits on profits, controls on spending, advertising, pricing etc. more in alignment with a utility company for example. ;-)

But this would require FDA to take action showing fraud against itself. And, assuming that means proving fraud in court - whidh FDA essentially never does - such a “fraud exception” to preemption would be, de facto, meaningless.

And then there is this: Even if the FDA _did_ prove fraud, FDA and DOJ argued in the Kent case that that its approved products (yes, even if approved through fraud) should _still_ be protected from lawsuits.

Barn door closed.

In general, I think that the pharma business has done more good than harm especially in the past. However, now, with the looming issue of preemption, I find it interesting that the FDA has chosen to send Warning Letters on this topic. Essentially, from my understanding of preemption (as it works in the device world), as long as the agency has taken an action, ANY charge or court filing is preempted by that action. This would include fraud on the FDA because there is currently no right of private action specifically mentioned in the law. In fact, the law specificaly states that the ONLY person capable of bringing any level of action against the industry in the FDA.

As a parent who refuses to medicate my child with this garbage which has (as far as I am concerned as a scientist, regulatory specialist and parent) NEVER been shown to do anything other than make it easier for the teacher in the classroom to handle a difficult student (oh, and by the way, in my own experience the most LIKELY person to suggest medicating a child is the TEACHER NOT THE DOCTOR) and to have a child become a zombie (and they DO NOT learn that way at all!). Sorry, these drugs should NEVER have been allowed on the market in the first place as far as I am concerned.

Overall, the problem with preemption is simple: if the FDA does ANYTHING then the right to bring civil actions would be completely and totally preempted (see FDA’s amicus brief in Levine and Riegel) by the fact that the FDA has ruled on whatever the issue might have been and the FDA is the sole decision maker in these actions. I find it funny sometimes that the FDA is so much the “expert” but that the FDA’s own people told the GAO a year or two ago that they were forced to or bullied into recommending approval of dubious drugs with incomplete or questionable safety or efficacy concerns.

Re: FDA’s powers, its Office of Criminal Investigation, in conjunction with the DOJ, can bring criminal charges. Along with civil penalties, that happened, for example, in the Neurontin case.

On the other hand…

Proving fraud is a tremendously complex business, in a criminal court - it requires proof of an intention to deceive, as you probably know. Civil actions, such as the one successfully pursued by Eliot Spitzer, against GSK, do not even allow one to say that GSK is a bunch of fraudsters - only a criminal court may do that. A regulatory finding? That’s got to be the next rung down on the ladder, hasn’t it? In any case, the FDA only has regulatory sanctions, as far as I’m aware, such as those you mention.

The facts of the matter are, to an extent, irrelevant, anyway. Human nature is at play, here: the FDA finds that a company has stepped across the line in a big way, let’s say. Perhaps in a way that, if the FDA had had its eye on the ball, it would have noticed. Let’s say that the company concerned advised the FDA of what it was doing, but nobody did anything, or worse, that this was a known problem, but the FDA had taken no action to ensure that a regulatory loophole was not exploited.

Suddenly, it’s the FDA’s fault, at which point the FDA is investigating itself. What kind of decision do you think it might make? The company isn’t stupid, after all - if the FDA tries to scapegoat the company, the company is going to let everybody know how crap the FDA is…

And so, it’s in everybody’s interests “to work together to resolve the matter, improving systems to ensure that the best interests of patients are served.”

Gosh, that does look cynical, doesn’t it? Experience can be a terrible thing.

Matt

I would like an explanation from Shire as to why Ty Pennington switched from Adderall XR to Vyvanse in the first place. Did Adderall XR not really work? Did Adderall XR stop working after initially treating his symptoms? Did he switch in some sort of cosmetic psychopharmacology experiment, just to see whether Vyvanse might work “better” than his current medication? What is Shire telling us here? That we shouldn’t believe their claims and their spokesperson’s claims about the efficacy of the medication they market and manufacture? Or that you should try a newer medication just to see if it’s better than the one that’s currently working? In other words: is Shire promoting bad medications or are they promoting bad medical practice?

I would like an explanation from Shire as to why Ty Pennington switched from Adderall XR to Vyvanse in the first place. Did Adderall XR not really work? Did Adderall XR stop working after initially treating his symptoms? Did he switch in some sort of cosmetic psychopharmacology experiment, just to see whether Vyvanse might work “better” than his current medication? What is Shire telling us here? That we shouldn’t believe their claims and their spokesperson’s claims about the efficacy of the medication they market and manufacture? Or that you should try a newer medication just to see if it’s better than the one that’s currently working? In other words: is Shire promoting bad medications or are they promoting bad medical practice?