An FDA summary of research exploring direct-to-consumer advertising calls for more studies on the impact of the ads on the patient-physician relationship.

"We continue to encourage research on all aspects of potential DTC influence on the interaction between patients and their physicians," the Nov. 19 ¹ report states.

The final report, entitled "Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs - Summary of FDA Survey Research Results," is an analysis of two patient surveys and one physician survey.

The patient surveys were conducted on 960 adults in 1999 and 944 adults in 2002. The physician survey was conducted in 2002 on 500 office-based physicians.

FDA conducted the studies "to evaluate the effects" of the agency's 1997 guidance relaxing limits on ads and of "DTC broadcast advertising, in general, on the public health and on doctor-patient interaction."

The study came away with mixed results. "Findings indicate that DTC advertising has important positive and negative impacts," the report states.

Among physicians, 72% "agree that DTC advertising increases awareness of possible treatments."

The report noted a decline in the number of patients who feel that "the ads help them make better health decisions." In 2002, 32% of patients felt the ads were helpful, down from 47% in 1999.

This decline, coupled with a 40% decline over the three years in patients who reported enjoying seeing DTC ads, suggest a changing public environment for the advertising format.

FDA Acting Commissioner Lester Crawford recently called on the industry to be more responsible in its DTC advertising (² Also see "DTC Ad Comparative Claims Draw FDA Criticism, Even With “Scientific Basis”" - Pink Sheet, 16 November, 2004.).

For DTC advertisements in magazines, the survey found that the percentage of people reading half or more of the brief summary "in general declined from 39% in 1999 to 27% in 2002."

"Rate of use [of the brief summary] should improve if the information is presented in consumer-friendly formats and language in place of the medical and legal jargon found presently in many, if not most, brief summaries," the report states.

- Andrew Shelton

FDA DTC Report Calls For Additional Studies

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