▪ Abstract Revised FDA regulations governing pharmaceutical companies' broadcast advertisements directed to consumers produced substantial increases in direct-to-consumer advertising (DTCA) expenditures. Proponents of DTCA claim it supports patient autonomy in the patient-physician relationship and has motivated some consumers to seek a physician's care for conditions they previously had not discussed with a doctor. However, DTCA's blend of promotion and information has produced more prescription drug awareness than knowledge—it has been largely ineffective in educating patients with medical conditions about the medications for those conditions. The evidence for DTCA's increase in pharmaceutical sales is as impressive as is the lack of evidence concerning its impact on the health of the public. Broadcast advertisements are too brief to include extensive technical information; consequently, the impact of FDA regulations to assure a fair balance of risk and benefit in DTCA is still being assessed.