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You're absolutely right about post-marketing, but I'm not sure the author was speaking about the same type of clinical review after the drug is on the market. One take-away I got from the editorial was that regulators at the FDA should be more careful about selling and prescribing meds off-label -- hardly easy, but consider what is the FDA doing about it now now -- next to nothing, and its impossible with the severe limitations the agency has on budgets and staff to enforce. But certainly disclosures about off-label usages and what the drug has been tested for (and what it hasn't) can be included among the 16-panel, onion skin, mice type disclosures that already accompany drugs today.

I suspect that some of this editorial was predicated by the recent scandal with Lilly's Zyprexa and how salespeople really pushed the use of that drug off-label. There, some teeth might have made a difference, think of what a stiff fine imposed on Lilly would have done to widespread off-label merchandising!

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