FDA's New View Of Drug Promotion: FDLI Meeting

The philosophy of drug promotion has changed, William Schultz, deputycommissioner for policy in the office of the US Food and Drug Administration Commissioner, told a recent meeting of the US Food and Drug Law Institute (see also pages 24-25 and Marketletter September 15).

The FDA's old argument for maintaining pre-clearance of marketing material and not allowing direct-to-consumer advertising because of limited resources will simply not cut it any more, he said. It has to look at things from the perspective of patient and industry needs, while still being aggressively committed to policing promotion.

The FDA, industry, doctors and consumers agree that prescription and over-the-counter drug information should be more comprehensive. Information is now provided with 60%-70% of prescription drugs dispensed (mandated to reach 95% by 2006). The task is to ensure the data are adequate, which will be done through FDA guidances and voluntary industry efforts, he said. When the FDA found prescription drug advertising on television was confusing consumers, it changed its policy. It is also looking at print ads and whether to change requirements for the brief summary, to make it more useful to patients, and at making information in advertising to doctors more useful.