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Hastings Law Journal

Abstract

The doctrine of informed consent should be expanded to require doctors to disclose: (i) off-label prescriptions; and (2) conflicts of interest created by drug-company marketing. Off-label prescriptions are those which do not comply with the FDAapproved use for the drug. While they are perfectly legal and a significant part of mainstream medicine, accounting for more than half of all prescriptions written today, in many instances they are not supported by scientific evidence, drive up the cost of health care, and expose patients to unnecessary risks. Conflicts of interest arise because drug companies provide free continuing medical education, pay speakers' and consultants' fees, offer bounties for prescribing certain drugs, and distribute mountains of gifts and free samples. Research establishes that these marketing practices increase the prescribing of promoted drugs and lead to non-rational prescribing decisions. To date, no appellate case has required these disclosures, and legal scholarship on these issues is surprisingly scant. As this Article explains, since this information is vital for patients to make informed health care decisions, it should be disclosed under the doctrine of informed consent.

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