The Pharmalot blog has a post up today on the prosecution of pharma companies for encouraging off-label prescribing practices. The key bit: Since 1997, when the Justice Department began receiving funding earmarked for fighting health care fraud, the AP…

First, thanks for writing.

Second, you sound just a wee bit like an attorney. which is fine - Its nice to have an informed point of view show up.

Third, you make a lot of good points. There are disagreements all the time, as I understand it, about what constitutes off-label marketing. And I would imagine some of that is good lawyering, and some is genuine.

I have a hunch the Washington Legal Foundation woulld have quite a lot to say about handing out articles (I covered the free speech issue several years ago, in fact, for The Star-Ledger and found it to be quite interesting, especially since I enjoy free speech myself).

I don’t mean to suggest that every company is out of compliance all the time, jousting over legal definitions aside. I was trying to point out that the issue, such as it is, continues to be a problem to be rooted out. In a word, vigilance is needed. And of course, disagreement over terminology or legal definitions shouldn’t automatically be used as cover for marketing a drug for an unapproved use.

I agree with you, however, that clarifying appropriate laws, to the extent such a move is needed, is a good thing. I won’t pretend to know, off the top of my head, specifics you might suggest. But I’m always happy to go to school. So if there are links you can send along, please do.

Cheers

ed

Also, according to AUSA Michael Loucks, there are over 500 ongoing illegal promotion/misbranding investigations going on.

Maybe the industry isn’t involved in massive illegal marketing. Maybe, just maybe, the laws are so unclear (intentially so by both the FDA and DoJ) that it is almost impossible for a company to be compliant.

For instance, if a drug company hands out information published in a peer reviewed journal (JAMA, for instance) that is inconsistant with the label, both DoJ and FDA would call that “illegal promotion” because it MIGHT result in a script being written for an indication not approved by the FDA.

Interestingly, the courts don’t believe this (FDA vs. Henney, FDA vs. Friedman). It would be interesting to see the Washington Legal Foundation’s views published in this article.

This really isn’t cut and dry, and I for one don’t believe the every company in the industry is involved in massive fraud via illegal promotion. If every company is facing the same issue, perhaps it is time for the regulatory bodies to clarify the law instead of forcing settlements from companies.

It bears noting that the government’s False Claims Act/ misbranding theory has NEVER been tested in court — by using the debarment statute (and the now rejected Thompson Memo) they force companies to settle. No one wants to take these to court because of the risk of debartment, and the government continues to be able to shake down companies for millions (which ultimately get passed on to the consumer; where do you think this money comes from?)