Tuesday, January 13, 2009

FDA lets drugmakers advise doctors on unapproved uses

It's not what you think. The FDA is allowing drug reps to distribute reprinted journal articles that may include information about off-label use. However, the reps are not supposed to talk about the article.

Off-label use happens incredibly frequently. However, health insurance plans may not be willing to pay for expensive drugs that are used off-label. Additionally, may physicians have prescribed agents inappropriately, and this has resulted in harmful outcomes.

So will the distribution of peer-reviewed publications that discuss off-label use be beneficial to patients? Since discussions about off-label use is OK in the world of CME, I think it could be very beneficial. After all, if a doctor is going to prescribe drugs off-label, he or she should be very educated about the evidence behind that use. Physicians need to know what types of risks and adverse effects may occur.

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