Package Inserts for Patients: Informed Consent in the 1980s
Curran, William J.
New England Journal of Medicine. 1981 Dec 24; 305(26): 1564-1566.
Federal court actions upholding the FDA's power to require patient package inserts in estrogen-containing oral contraceptives are briefly reviewed. Although court language may suggest that package inserts have a role to play in obtaining a patient's informed consent to treatment, the author maintains that this is an oversimplification: the insert is seen by the patient too late to influence the basic decision to follow the physician's advice. Moreover, if the FDA requirement were extended to all drugs, and did not allow physicians to override the requirement for particular patients, patients who rejected medication without consulting their physicians could be harmed. (KIE abstract)
Consent; Drug Industry; Drugs; Education; Food; Government; Government Regulation; Industry; Informed Consent; Legal Aspects; Organizational Policies; Organizations; Patient Education; Patients; Physician Patient Relationship; Physicians; Political Activity; Professional Organizations; Power; Regulation; Risks and Benefits;
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