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CLB Journal Club with Kelly Lowenberg

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September 22, 2009 12:45pm - 2:00pm

Room 271
Doctors are allowed to prescribe drugs to treat illnesses other than those for which the FDA approved the drug's use. This off-label use is very common, constituting about 1 out of every 5 prescriptions written. Although these off-label uses do not require formal clinical trials, they should be based on scientific evidence that they are safe and effective. A recent survey, however, indicates that doctors may not know whether the prescriptions they write are off-label, and in some instances believe a use to be FDA-approved that, in fact, has no scientific support. What steps could be taken to protect patients from off-label prescriptions that are unsafe for their illness? And how can doctors and manufacturers improve patient care and better protect themselves from liability? Some issues we may discuss include: education about off-label uses, informed consent, limits on manufacturer's promoting off-label uses and the First Amendment, the manufacturer's duty to warn about risks, and federal pre-emption. Additional reading will be emailed with the announcement. Discussion facilitated by Kelly Lowenberg.