DDMAC Director Says Quality of DTC Ads Has Decreased

The overall quality of direct-to-consumer (DTC) advertising has been declining, according to the head of the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC), which last year issued a record number of warning letters for violations of the agency's ad requirements.

Recent DTC promotions have faltered in three areas, DDMAC Director Tom Abrams said in an exclusive interview. "The presentation of risk information is not as good as it could be," he said. "The overstatement of efficacy is occurring in some ads, and the overall tone is sometimes interfering with the presentation of important information. The industry can do a better job in those three areas, and I would encourage them to do so."

This message, in fact, may be getting through to industry. Drugmakers have acknowledged in recent months that aggressive and pervasive DTC advertising is contributing to a negative image of the industry. A growing number of pharma leaders are calling for changes in advertising practices, such as ensuring that ads present a balanced view of products' risks and benefits and ensuring that ads have educational value.

Firms that don't convey the appropriate balance of risks and benefits in their ads are risking enforcement action from DDMAC, which has become increasingly active on the warning letter front. In 2004, the division issued 12 warning letters out of a total of 23 letters issued, which included untitled letters. "Typically, we issue between four and five a year," Abrams said of the warning letters, which are prompted by serious promotional violations that may pose a public health risk.