And are you saying that companies actually have a separate compliance program in California, and now Nevada, than they do for the rest of the states?

Beyond that, I’m surprised that two such staunch defenders of pharma are happy to attack a bio firm. A little internecine rivalry?

I do think FDA should have more power in pursuing off-label promotion cases, but not necessarily through the DoJ - according to the Washington Post, the DoJ has a 10 year backlog of whistleblower cases to deal with. Of the over 900 cases filed, more than 500 of them involve healthcare and pharmaceutical industries. So what does that say? Viva the PhRMA Code?

Justice and others,
While the feds may not act on off-label promotion, my company IS acting. Keeping my job is a more immediate and compelling impetus to some reps than federal law to play by the rule book. And many, many doctors are more questioning of whether a claim is on-label or not. What irks me is that because smaller firms do indeed “fly under the radar,” I am selling with one arm tied behind my back–and increasingly, it feels like a gag in my mouth. I don’t want to sell off-label, but I would like to be able to raise points of fact from approved clinical articles; in its fear of federal retaliation, my company won’t let us do even that. The FDA scrutinizes the promotional efforts of some companies much more than others…

I find it ironic that there was such uproar about Neurontin, as benign a drug as it is possible to find (people take GRAMS and GRAMS of the stuff), while Tysabri is actually killing people and you hear nary a peep. AND it is expensive–isn’t using it outside of the TOUCH protocol fraud if Medicare Part D or Medicaid pays for it?

I am aware of California’s requirement, but the vast majority of those states do not have such a requirement. I am well aware that smaller pharmaceutical companies are able to fly under the radar with activities that would be against the PhRMA code. This includes biotechs. Moreover, Biogen-Idec’s code, as I read it, only apples to activities in California. For members of PhRMA, the code is a requirement throughout the country. It would be interesting to see BIO adopt a similar code of conduct.

Atlex

Any company - pharmaceutical, device, or bio - that sells in California is required to certify that they follow the PhRMA guidelines and have a “comprehensive compliance program” based on the OIG Guidelines - I’m surprised you don’t know this. That said, they do not always make this assertion easy to find.

Biogen Idec’s can be found here.

All words have dangers.

Yes, it would appear the GAO is saying that ‘W’ seems to always stand for whistleblower, at least in the context of this report.

ed

viz p. 2 of the report: “While FDA did not refer _any_ of these violations to DOJ for enforcement action, during calendar years 2003 through 2007, DOJ settled both civil and criminal cases that involved, at least partially, off-label promotion. These actions were initiated as a result of violations identified by sources _other_ than FDA and resulted in 11 settlements.” [emphases mine]

Thus, worse than Keystone Cops. No cops at all. And no actual prosecution; all settlements.

Among other things, this means that even if there _were_ a “fraud exception” under preemption (which there ain’t), none of the cases would qualify, because no convictions.