October 12, 2007

Physicians are currently using two different drugs to treat a degenerative eye disease that commonly affects older Americans. One of the formulations has been explicitly tested for this purpose. The other is being used "off-label," i.e., based on a physician's expert judgement that the drug will be effective.

Now here's the rub: both drugs are both from the same company, Genentech, and are variants of the same active ingredient. Says the New York Times:

Lucentis is approved to treat wet age-related macular degeneration, the most common cause of blindness in the elderly. But it costs about $2,000 a dose, with treatment needed as often as once a month.

In a letter yesterday to retina specialists, Genentech said that its wholesalers would no longer provide Avastin to compounding pharmacies - companies that under sterile conditions can divide a vial of Avastin into tiny portions for use in the eye. The company said the distribution change would take effect Nov. 30.

Now, companies limiting the use of their own drugs is never a good idea, PR wise.

But criticism directed at Genentech over their pricing of Lucentis does point out a certain perversity of current FDA labeling guidelines. Companies are not allowed to advertise or otherwise encourage off-label uses of their drugs, which means that they are forgoing a certain amount of revenue.

If they want to add a new treatment indication to a drug's label, they must engage in lengthy and expensive clinical testing - and it only stands to reason that they ought to be able to recoup the costs of such testing, plus a respectable profit. Genentech followed the FDA's guidelines in this case, but are under heavy criticism for promoting Lucentis over Avastin.

The FDA's restrictions on off-label advertising put companies into a damned if you do, damned if you don't position. Off-label use is a powerful and productive way for doctors to rapidly offer new treatments to patients based on their knowledge and experience; but we would still like companies to study those off-label uses, and to help validate them.

By liberalizing the rules over off label promotion of drugs - perhaps based on a drug's mechanism of action combined with additional data collection guidelines - we can give companies a financial incentive to do more research on off-label uses and give patients and doctors more information on which make informed treatment decisions.

Posted by Paul Howard at October 12, 2007 01:44 PM

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