Patient autonomy and the regulation of direct-to-consumer advertising.

BACKGROUND The current direction of the US Food and Drug Administration (FDA) policy on direct-to-consumer advertising (DTCA) of pharmaceuticals is a subject of debate. The literature addresses the benefits and drawbacks of DTCA, but the foundations for such policies have not been investigated in detail. OBJECTIVE This paper explores the most recent FDA guidance on broadcast DTCA based on a critical examination of the principle of autonomy. CONCLUSIONS Autonomy is determined not by the ability to choose a therapy, but by the ability to actively participate in choices about health care. DTCA can be an effective tool to increase patient awareness of their therapeutic choices, encourage patients to seek more information, and help them draw closer to autonomous choices, but only if the presentations provide fair and balanced information on the benefits and risks of therapy.