Wednesday, January 30, 2008

A question for my new friends

A vendor stopped by the other day, and we had an interesting chat about what they are doing for my company, and any legal issues that might pertain.

You see, they're performing social media monitoring for us, for a number of our products, and for our corporate image in general. They're checking out a number of blogs, using technorati and other blog rating tools (I forgot to ask about blogshares! Pick up your shares of pharmablogger today! Cheap!). They're following product discussions on cancer and psychiatry related patient websites. And they're giving us reports on everything they read.

I thought about one of our products in particular that has two key characteristics that interest me. First, it the subject of massive litigation, and second, it has a large amount of sales for off-label uses. Now, I've previously invoked the Divine Wow in these pages, asking that he guide our sales force to be not advising docs about these off-label uses. So for the moment, let's assume my prayers have been heeded, and we won't be on the wrong end of another Neurontin suit.

Yet our product teams are receiving reports about all of the off-label use of our drug from these vendors, as well as reading accounts such as this Wall Street Journal article about dementia patients, accompanied by warnings from the FDA like this. We also know that we're selling outsize amounts of low-dose tabs of our drug, that would not amount to therapeutic doses for its intended purpose, but are enough for the common off-label use. And then there's the IMS Health data. In short our sales force know what's going on out there.

So with all this knowledge about our product and how it's being used in the real world, how protected are we by simply claiming, however accurately, that we're not actually promoting the off-label use? Or in other words, does all of this awareness impose any duty on us to act, to warn, to advise doctors not to use our product inappropriately?

I posed the question to the vendor, and asked if they are providing any legal advice with their website content reports. That's not their function, it turns out. It should probably be mine, but I'm too tired to do the Lexis search tonight.

Even if I didn't find anything, just imagine the jury impact of the facts above. Our company is raking in billions of sales from a product that has a huge percentage of off-label use, that is inappropriate and harmful and maybe even fatal according to the FDA, and we're very aware that this is taking place, even if we're not instigating it, and we're not doing anything to stop it. How would you rule?

I might also add that we are not the only ones researching ourselves on the net. The plaintiff firms and "natural products" companies are doing it as well, but at least we're not actually posting or steering discussions in the patient forums (fora?). Heartening to know we're at least a half-step more ethical than law firms, isn't it? And of course, all-natural products never harmed anyone, right Socrates?


Pharm Aid said...

This is a really interesting question.

I've posted a full reply on my blog:

In brief, legally, I wouldn't know. But some lawyer scum could probably get a jury to go its way in a civil case.

Ol Cranky said...

I don't think a company is legally responsible for off label use or to dissuade off label use. My guess is that most companies would actively try to dissuade an off label use only if/when they are sufficiently concerned that the safety profile of the product will take a significant negative hit by continued use in the non-approved indication, they fear they will be enjoined in lawsuits and/or the use will generate significant negative press for the company (i.e., the anti-abortion protests of Monsanto/Searle because misoprostol is administered as an adjunct to RU-486).

My own company is fully aware that 75 - 80% of the sales of our product are off label. Since we do not promote off label use, executive management argues that tracking the off label use allows medical affairs to better support those physicians who use the drug for non-approved indications.

I think companies with injectables administered in a physician's office assist physicians in obtaining insurance approval for treatment of a patient for an off-label use. They also have strategic business managers whose job it is to liaise with insurers to obtain coverage for off-label indications and may well have MSLs/medical affairs physicians who conduct injection training for off-label indications. I've often wondered if, in offering this sort of assistance, these companies could really claim not to be promoting off-label use. I'd be willing to bet that any action that is perceived as impeding a companies ability to continue these activities would be met with a cry that first amendment rights are being violated and patients would be put at risk.

* The company really does promote off label to the point that sales and company goals are actually based on these off label sales.