Off-Label Sales: Some Companies Don't Learn

When a company has paid over $300 million in various fines (not to mention the legal fees accompanying huge lawsuits) since 2004, one surmises that the company will have learned a lesson and become ultraconservative.

Unless your company is Bristol-Myers Squibb.

BMS will pay $499 million to settle charges on price inflation, bribing doctors, and illegally promoting antipsychotic drug Abilify (aripiprazole) for off-label use. Abilify is approved to treat bipolar disorder and schizophrenia in adults. BMS is accused of illegal promoting Abilify for treating children and elderly patients by deploying sales teams to call on doctors that see these patient populations: child psychiatrists, pediatric specialists, and those working in long term care.

Bristol-Myers Squibb follows the string of pharma companies like Pfizer, Schering-Plough, and Serono that have been prosecuted for illegal off-label promotion and will enter into a corporate integrity agreement (CIA) with the Department of Health and Human Services. To be fair, Pfizer inherited the lawsuit by acquiring Warner-Lambert.

If I were to try and explain why off-label promotion seems to keep happening even in light of all these lawsuits, I would suggest that doctors often are using various drugs off-label anyway, and it would be irresponsible for the companies that have the most information about their own drugs not to share at least some safety and efficacy data with doctors. There is some truth to this phenomenon. That said, I don't buy that companies are completely innocent, either.

As with all the companies that settle charges by paying large fines, BMS does not "admit to any wrongdoing".

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Jane Chin, Ph.D. Of Jane Chin Associates

	Thanks for your comment, Erica. You are right in that educational grants are given to 3rd parties that technically should remain "independent". One of the criticisms of pharma-industry supported medical education programs is that these so called independent 3rd parties may not be as independent as we think, especially those companies that earn significant revenues from pharma company clients. There have been indeed cases where a pharma company exercises enough control over content "direction", audience- and speaker selection to render such programs promotional even though it is marketed as an independent CME. This is rarer now given the scrutiny over industry sponsored programs. To round off the various factors contributing to off-label marketing pressures, Wall Street also plays a role, where analysts often include off-label sales of a drug to then project growth and thus attractiveness of investing in a certain pharma company.
	Mon Oct 1, 2007 8:49 AM

Erica Richards Of Commerce Bank

	Obviously some of pharma's marketing agenda is to grow the off label uses of its drugs. That said, there is some loss of control when providing grants to third party content producers. Even though the 3rd parties know what they have to produce to continue getting grants, that content is still under the editorial control of the 3rd party. All I am saying is that "admitting to wrong doing" may actually be a literal lie as in many cases where on or off-label info is distributed; pharma isn’t actually the mouth piece.
	Sun Sep 30, 2007 9:35 AM

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