Eisai Company Ltd (ESALY)

[flemsnopes]

Having the cake and eating it too.
http://www.uspharmacist.com/content/d/pharmacy_law/c/32890/

The manufacturer of bexarotene, Eisai Co., based in Japan, is being a bit vague in its public statements about this potential off-label use of its product. Instead of coming right out and saying that the drug should not be used in humans until further research is performed, its spokesperson was quoted as saying, “It is our policy to not comment on off-label uses of our products. Physicians are able to prescribe products as they see medically necessary.” The company also disavowed any knowledge of the research study published in Science.17

That is a great way for a company to have its cake and eat it too. Companies can say that they do not have any control of how their products are used once they leave their factories, but they will be happy to take the profits from off-label uses if such an occurrence happens. While this may well be an accurate point of view at some time down the road when human-use evidence is collected, from an ethical perspective, the company should be saying this drug has been approved in the U.S. for a very narrow and specific use and should not be used for other purposes at this time. Perhaps that time could come in a relatively short period if clinical trials were opened under the auspices of an FDA Investigational New Drug Application (INDA) with the approval of the Institutional Research Board (IRB) where the research might be conducted.