Back to the drawing board for off-label marketing strategy

The FDA approves drugs for specific purposes (“indications”) and labels the drugs accordingly. Sales reps and ads from pharma companies are only allowed to promote the drug for the labeled purpose, but doctors can typically prescribe the drug for whatever they want. This has led to pharma companies deploying “scientific liaisons” who are allowed to discuss off-label use, and sometimes going over the line in commercial marketing to promote “off-label” uses. For some drugs, especially in oncology, more than half of prescriptions are for off-label use.

A typical commercialization strategy has been to get a drug approved for a specific indication, and then try to broaden the drug’s use over time through approvals for new indications or by promoting off-label use. But that tactic may be coming under a new form of pressure.

In 2003, AstraZeneca’s Iressa won accelerated approval from the FDA without clear evidence that it worked against lung cancer. Ordinarily, AstraZeneca would have been able to keep marketing the drug –and physicians free to continue prescribing it– for on label and off-label use. But, after a follow-up trial demonstrated essentially no benefit for Iressa, the FDA has decreed that Iressa will only be available to patients who have taken the drug and shown benefits. (See AstraZeneca Faces Restricted Use For Cancer Drug in the Wall Street Journal.)

Supposedly this restriction doesn’t represent a new policy, but my guess is that FDA is experimenting with how to rein in off-label marketing. Pharma companies may have to rethink their commercialization strategies, and it’s another reason we may see more sales force reductions such as those at Wyeth and Pfizer. (See below.)

June 20, 2005

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